Daughters of Premarin®: The Generics


FURTHER to the reference of generics in the “Alternatives to Drugs Made with Pregnant Mare’s Urine”, I think a separate word on the availability of generic Premarin® and its daughter drugs is warranted to clear up any confusion for those seeking to avoid products manufactured from the urine of pregnant mares.

Premarin has a long and interesting history when it comes to FDA approval of generics, a history mired in the ruthless and bloodthirsty battle of Big Pharma patent wars.

Many years ago, in 1986, the effectiveness of Premarin®’s, and other short-term acting estrogens, ability to diminish bone loss associated with osteoporosis was granted approval by the FDA. What was once a drug that was prescribed for the relief of menopausal symptoms now became the panacea for a long-term chronic problem. [1]  And with this came a huge untapped market.

At this time there were certified generics that were interchangeable with Premarin®.  However because of the ramifications of long-term use, the science behind the drugs prevailed.

While Premarin® provided slow-release bioavailability, the generics were immediate release. This disparity in mode of release would turn into a long battle between the generic manufacturers, Wyeth-Ayerst and the FDA. [2]

To make a long story short, the outcome of detailed analysis showed that the bioavailability of generic versions was not equivalent to Premarin® and in 1991 the FDA withdrew approval of all ANDAs (Abbreviated New Drug Applications) proclaiming that none of the synthetics on the market could be considered generic versions of Premarin®. [3]

Because of the lucrative market potential, two generic manufacturers – Duramed and Barr – set out to develop products that solved the bioavailability problem and submitted ANDAs for FDA approval. Both met the requirements of adsorption efficiency however Wyeth had been conducting its own research and contested FDA approval on the grounds that the generic drug lacked one of the estrogens, called delta 8,9 (dehydroestrone sulfate), present in Premarin®.

Nevertheless, in 1994, the FDA unanimously ruled that delta 8,9 (dehydroestrone sulfate) was an impurity and not a required ingredient of a generic version.

Duramed applied for FDA approval of Cenestin in September 1995, and Barr followed the next July. [4]  

What happened next effectively blocked any competitor from manufacturing a generic Premarin®. Propaganda and political persuasion tactics were used to coerce the FDA and in 1995 Wyeth-Ayerst successfully petitioned the FDA to require the presence of delta 8,9-dehydroestrone in any generic version of Premarin®. [5]  Together with Wyeth-Ayerst’s patent on synthetic delta 8,9-dehydroestrone, this shut out the competitors.

Eventually Duramed filed a NDA (New Drug Application) for its synthetically derived estrogen Compound Cenestin which is still available on the market today along with a variety of other synthetic products, none of which contain pregnant mare’s urine.

Premarin® lost its patent in February 2012 and the patent for Prempro® held by Wyeth Pharmaceuticals, does not expire until early 2015. 

Despite Premarin’s® patent expiration there seems to be no interest in manufacturing a generic version from pregnant mare’s urine. [6]  In any case, it would be challenging for another pharmaceutical company to synthesize a medication that is similar enough to Premarin® to receive the approval of the FDA, similarly so for Prempro® as it contains the same natural conjugated equine estrogens as Premarin®.

The so-called Premarin generics are the lab-synthesized versions manufactured from plant sources not pregnant mare’s urine (see “Alternatives to Drugs Made with pregnant Mare’s urine). [7] 

As a reminder, these drugs carry with the same serious risks as the Premarin® family of drugs.

Some will say that generic Premarin® is available online without prescription, particularly from Canada. However be wary of any medications that tout themselves as being a safe generic version of Premarin®. Congressional testimony from the US FDA points out the dangers of inadequately regulated foreign Internet sites which have also become portals for unsafe and illegal drugs. This excerpt specifically targets Canadian generic websites: [8]

“A recent example illustrates some of the dangers associated with the purchase of prescription drugs from rogue pharmacy sites. Within the last six months, FDA has examined two web sites having identical web pages headlined “Canadian Generics” which were identified through spam e-mails sent to consumers.  FDA has purchased prescription drugs from both of these sites, and has found that these drugs and the manner in which they are sold pose potential threats to the health and safety of consumers.

There is at least one Canadian flag on every page of these sites, as well as the words “Canadian Generics.”  The web sites say, “Order Canadian to get the biggest discounts!”  Both of the URLs from which the orders were placed suggest the sites are located in, and operated out of, Canada. Despite these representations, however, we determined there is no evidence that the dispensers of the drugs or the drugs themselves are Canadian. The registrants, technical contacts, and billing contacts for both web sites have addresses in China.”

There is currently no therapeutically equivalent version of Premarin® available in the United States.  In other words, there is no approved generic for Premarin in the US.

The drug policies and generic approval practices in other countries may vary. What is a generic in one country may not be approved as one in another.

Fraudulent online pharmacies may attempt to sell an illegal generic version of Premarin®. These medications may be counterfeit and potentially unsafe.

If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. [9]

Consult Your Doctor

Always consult your doctor before embarking on any change in medication


[1]  http://pubs.acs.org/subscribe/archive/mdd/v03/i08/html/kling.html
[2]  Same as at 1.
[3]  Same as at 1.
[4]  http://www.sagepub.com/jowett5estudy/cases/77821_c2.pdf
[5]  Same as at 4.
[6]  http://www.drugs.com/availability/generic-premarin.html
[7]  http://www.horsefund.org/pmu-alternatives-to-cee-drugs.php
[8]  http://www.fda.gov/newsevents/testimony/ucm113635.htm
[9]  Same as at 6.


The Quest for a Generic Premarin – A Bitter Pill to Swallow, By JANE ALLIN, Tuesday’s Horse, Nov. 14, 2014 »

Premarin Timeline 2014

Duavee enters the marketplace

Pfizer’s latest menopausal drug Duavee, the combination menopausal-osteoporosis drug, comprised of conjugated equine estrogens (Premarin) and bazedoxifene (Selective Estrogen-Receptor Modulator) was approved by the FDA on Oct 3, 2013 and was available to the marketplace in the first quarter of 2014.

However the FDA approval was not without provisions. Due to the heightened risk of endometrial hyperplasia, potentially a precursor to endometrial cancer, Wyeth/Pfizer is required to conduct a post marketing pharmacokinetic trial to evaluate the effect of conjugated equine estrogens and bazedoxifene on imminent changes in endometrial tissues within the selected cohort of non-obese and obese postmenopausal women. See http://goo.gl/mFpmON»

In effect the FDA has granted them permission to sell this concoction to unsuspecting women despite the undeniable concern that there is an increased risk of endometrial cancer. The final report from Wyeth/Pfizer is to be submitted by 04/2015 – an entire year and a half after its approval.

Pfizer had a lackluster first quarter, and the continued profit decline, accompanied by a lack of groundbreaking drugs on the horizon, disappointed investors. Despite the fact that Duavee took years to get to market along with biased studies, inexcusable side effects, questionable data and the fact that the FDA has yet to approve bazedoxifene as a stand-alone drug, Pfizer is pinning its hopes on Duavee to pick up the slack.

Pre-and post-market availability of Duavee, Pfizer ramped up an aggressive direct to consumer campaign and boosted its marketing efforts that continued throughout the year, not only for its new drug but also Premarin tablets and vaginal cream. Similarly medical doctors were plied with the benefits of Premarin and Duavee and encouraged to prescribe it to their patients – particularly Duavee – the so-called “safer” of the two drugs.

In late May 2013, Pfizer followed several other pharmaceutical companies in their quest to extend the period of their New Chemical Entity (NCE) exclusivity for their Fixed-Dose Combination drug Duavee to 5-years from the 3 years they were granted when it was approved on October 2013. To date the FDA has denied all petitions. The reasons for Pfizer’s fight for a 2-year extension are unclear – bazedoxifene has yet to be granted approval by the FDA nor is there a generic version of Premarin on the market.

Pfizer continues to fight its legal battles in the courtroom over the carcinogenic effects of the Premarin family of drugs. Of note is a class action lawsuit pending in Canada that has the potential of proving this to be true in a high number of cases, revealing important facts and figures previously uncovered – the body of evidence to date overwhelmingly points to a causal connection between the use of Premplus and the development of invasive breast cancer in women.

In a Canadian study conducted by the Canadian Cancer Society, its top epidemiologist alleges that popular menopause drugs made in part from estrogen found in the urine of pregnant horses have caused breast cancer in thousands of Canadian women. Wyeth, now wholly owned by Pfizer continues to deny this of course.

A blow to horse advocates and those opposed to the use of CEE-containing hormone therapies came in October of this year with the news that Kim Cattrall, star of Sex and the City, teamed up with Pfizer to promote Duavee in a campaign called “Tune into Menopause”. This, despite the fact that Cattrall is not a Duavee patient, has the potential to influence and encourage many women to take this drug.

On October 27, 2014 the combination conjugated equine estrogen / bazedoxifene venom, to be sold under the name of Duavive, was recommended for approval by the European Medicines Agency (EMA) so it is only a matter of time before it is available in Europe.

After the launch of Duavee in the first quarter of the year Pfizer reports that the sales of their combo drug have grown to more than 5,000 prescriptions per month. Sales projection for 2014 is approximately 100 million USD, estimated to double by the year 2020. See http://consensus.druganalyst.com/Pfizer/Duavee/#

Last but by no means least, the horses. In North America the NAERIC (North American Equine Information Council) website lists the number of mares on the PMU farms as 2,000.

NOTE: It is well known however that the primary production of CEEs for the manufacture of the Premarin family of drugs now takes place overseas in Asian locations (China, possibly India). As for the exact number of farms and mares on the pee lines this has yet to be confirmed. Needless to say, they must far out-number those left here in North America. How long will it be before the ranches here disappear? —Jane Allin.

Pfizer turns the sex talk toward 50-ish women with a menopause awareness push

Anyone who’s watched a Viagra commercial knows that Pfizer ($PFE) isn’t too embarrassed to talk about sex. Anyone who’s run across Pfizer’s “Get Old” campaign knows it doesn’t shy away from aging, either. Now, the drug giant is going equal opportunity on the sex-and-aging talk, and “Desperate Housewives” actress Brenda Strong has the dialogue.

With its latest menopause awareness campaign, Pfizer is taking a break from hot flashes and night sweats. Instead, it’s focusing on some lesser-known effects of menopause, namely painful intercourse and vaginal atrophy. They’re not terms tossed around at your average dinner party, and Pfizer’s campaign capitalizes on the uncomfortable.

Aptly titled “Let’s Talk About Change,” the campaign has launched with a YouTube video titled “The Other Talk.” In one scene, Strong’s character engages her daughter in the birds-and-bees conversation so often lampooned in Hollywood comedies. Predictably, said daughter closes the door in her mother’s face. But then the tables are turned. Strong’s character finds herself in an awkward conversation with her mother–about menopause and its effects on her mother’s sex life.

Pfizer’s point is that women need to talk to someone about these little-known effects of menopause. If not their mothers, then perhaps their partners–and most importantly for Pfizer, their doctors. “It’s our hope that ‘The Other Talk’ video will prompt new dialogue about the symptoms of post-menopause,” Strong says in a Pfizer release. “The video is funny, but has an important message–more women should be talking about these changes and taking action to help find relief. Women should not have to suffer in silence.”

If women did ask their doctors–and if the conversation goes as Pfizer might hope–women would not only hear about symptoms but also get information about the company’s products for those very symptoms.

To give a nudge, the “Let’s Talk” home page includes a link to Pfizer’s Estring brand website. A vaginal ring that releases estrogen over a 90-day period, Estring is approved specifically to treat any unpleasant menopausal changes in the vagina and is designed to act locally rather than systemically. Among its rivals is Osphena, approved in February 2013; Shionogi specifically touts it as a nonestrogen treatment for vaginal changes around menopause.

Estring is just one in Pfizer’s lineup of hormonal treatments for menopausal side effects. Its Premarin line of products, acquired along with Wyeth in 2009, still generates blockbuster-level sales, with $768 million for the first 9 months of 2014. Pfizer knows well about potential side effects of hormonal therapy in menopausal women; it paid $1.2 billion in 2012 to settle lawsuits over its Prempro drug and its links to breast cancer.

In October 2013, the company won approval for Duavee, which pairs estrogen with bazedoxifene, an ingredient designed to temper some of the safety risks that can accompany solo therapy with estrogen. Approved to treat hot flashes and to help prevent postmenopausal osteoporosis, the drug goes up against a new nonhormonal pill for hot flashes, Brisdelle, and a variety of hormone-based osteoporosis fighters, including Eli Lilly’s ($LLY) Evista. END

Source: FiercePharma »

Pfizer is stuck with a hot flash med that took years to get to market

Project name: conjugated estrogens/bazedoxifene
Disease: Moderate-to-severe vasomotor symptoms
Peak sales estimate: $200 million
Approved: Oct. 3
Companies: Pfizer and Ligand Pharmaceuticals

Pfizer ($PFE) already had treatments for menopausal women in its quiver when it got approval for Duavee, a drug it acquired in its buyout of Wyeth in 2009. In fact, what it refers to as its Premarin family of products, which also came with Wyeth, generated more than $1 billion in sales last year. But while many women would like to find something to treat hot flashes, they have been scared off by a decade of discussion over the risk of developing breast cancer after taking hormones for the symptoms.

Duavee is approved for moderate-to-severe hot flashes related to menopause in women who haven’t had a hysterectomy as well as for prevention of postmenopausal osteoporosis. It differs from other hormonal treatments by being the first to combine estrogen with the estrogen agonist/antagonist bazedoxifene, which reduces the risk of endometrial hyperplasia. Some experts think the combo may mean it will have fewer of the increased cancer and other risks that have plagued earlier drugs in the category, including Prempro and Premarin. The company certainly understands the potential downside those risks pose; it has reported that litigation tied to these risks in its hormone products have cost it about $1.6 billion over the years.

Pfizer touts the drug as a hormone therapy with few of the side effects associated with similar treatments, but it has a risk history of its own. Originally known as Aprela, Wyeth started work on it in 1999, as part of a program with Ligand ($LGND). They had hoped for a 2007 approval, but FDA concerns over health risks kept pushing that opportunity further into the future. Still, some experts say Duavee may not carry the same safety concerns about long-term use of estrogen. Doctors who treat women with menopause know their patients are ready for a treatment option.

Duavee, however, is not the only alternative approved this year, and its competitor does not rely on hormones for its benefits. Brisdelle from Noven Therapeutics, a unit of Hisamitsu Pharmaceutical, is the first nonhormonal treatment for hot flashes. What it does contain is paroxetine, the same ingredient found in the popular antidepressant and antianxiety drug Paxil. Paroxetine carries a boxed warning about the risk of suicide associated with its use in children and young adults, and so the drug carries that as a boxed warning.

Pfizer could have given up on Duavee. Some analysts did, surmising it would never get to the market. That makes it difficult to gauge its potential earnings power. There have been forecasts that it could generate $200 million. But given that sales of the Premarin family of drugs top $1 billion and Eli Lilly’s ($LLY) Evista for prevention of postmenopausal osteoporosis also reaches blockbuster status, it is hard to say. — Eric Palmer. END

Source: FierceBiotech »

The Horses

Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

More Timeline

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THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2019


FDA denies Pfizer Petition asking for new method of assessing Premarin generics

The FDA has denied a citizen petition from Pfizer calling on the agency to use the company’s method for assessing sameness in generics for its estrogen drug Premarin (conjugated “equine” estrogens).

Pfizer had appealed to the FDA to force sponsors of generics for Premarin to use the “Pfizer method” for assessing sameness rather than the method recommended in FDA draft guidance.

Pfizer claimed that the FDA’s December 2014 draft guidance for establishing sameness is “fundamentally flawed”. Additionally claiming that not only does it lack a critical level of sensitivity on API (Active Pharmaceutical Ingredient) steroidal composition, but also it does not account for all classes of components in the API or the non-steroidal components.

They maintained that guidance should instead use the “Pfizer Method” that the company developed at the FDA’s request and with their input, which permits a determination of sameness between a proposed generic for the company’s drug Premarin and the reference drug based upon the mixture as a whole, while allowing a comparison across all categories of components making up the API.

APRIL 2019

Bijuva launched for moderate to severe hot flashes in menopause

TherapeuticsMD announced the launch of Bijuva (estradiol and progesterone) capsules for use in women with a uterus for the treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause. It initially received approval from the Food and Drug Administration (FDA) in October 2018.

Bijuva is the first bio-identical hormone therapy that combines estradiol and progesterone in a single capsule. Compared with synthetic hormone products, the estradiol and progesterone found in Bijuva are structurally identical to the hormones naturally circulating in the woman’s body.

Bijvua carries a Boxed Warning regarding cardiovascular disorders, breast cancer, endometrial cancer, and probable dementia. Breast tenderness, headache, vaginal bleeding, vaginal discharge, and pelvic pain were the most common adverse reactions associated with Bijuva.

JUNE 2019

PMU Ranchers feel pinch as cuts announced

Pfizer Canada’s cuts to pregnant mares’ urine production will force four Manitoba ranches and one Saskatchewan ranch out of the industry.

The reduction affects three ranches in southwestern Manitoba, one in the Interlake region of Manitoba, and one in Saskatchewan. Of those five, three producers raised registered Quarter horses, one bred purebred Percherons, and one raised sport horses.

Pfizer has initiated a review of its inventory management and determined they are able to satisfy market demand by working with fewer ranchers.

The latest reduction leaves 19 producers still involved in PMU production in Manitoba and Saskatchewan, with most ranches located in southwestern Manitoba, four each in south-central Manitoba and southeastern Saskatchewan and one in the Interlake.

JULY 2019

Pfizer’s Wyeth loses bid to duck hormone-therapy lawsuit

Pfizer Inc’s Wyeth unit must face a class action alleging that the drugmaker misled California women by downplaying risks including breast cancer associated with its hormone-replacement therapy products, a federal judge has ruled.

U.S. District Judge John Houston in San Diego on Monday ruled the plaintiffs presented sufficient evidence for a jury to decide whether Wyeth’s alleged misrepresentations caused women to buy Prempro, Premarin and Premphase.

To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2FOpbRU »

New Book — Flash Count Diary: Menopause and the Vindication of Natural Life, by Darcy Steinke

“What orcas can teach humans about menopause and matriarchs“, A new book argues for a sea change in the way our culture views older women

Her research unearthed a long history of dubious “cures,” from transfusions of dog’s blood to vinegar sponge baths to putting a magnet in your underpants. All of which, she says, seem a little less strange once you realize that the most popular hormone replacement treatment, Premarin, is made from the urine of pregnant horses. Source: Crosscut »


Hormone therapy during menopause raises breast cancer risk for years, study finds

New analysis adds to the evidence that many women who take hormone therapy during menopause are more likely to develop breast cancer — and remain at higher risk of cancer for more than a decade after they stop taking the drugs. 

The study, in the Lancet, looked at data from dozens of studies, including long-term data on more than 100,000 women who developed breast cancer after menopause. The longer women took the medicine, the more likely they were to develop breast cancer. Experts say the findings could shape how women and their health care providers decide how to manage symptoms of menopause.

For years, research has suggested a potential link between MHT and an increased risk of breast cancer.  But there wasn’t much information on whether that risk persisted, or how it differed based on the type of MHT a woman took. So, an international group of researchers pulled together data from dozens of studies — published and unpublished — to examine the issue more closely. 

The researchers found that compared with women who never used MHT, women who did had a significantly higher risk of developing invasive breast cancer. Also, the longer women used MHT, the greater their risk of breast cancer. 


Premarin sales figures continue to deline

The Premarin family of hormone replacement products was the 11th best seller in 2018 at $832 million, a decline of 14.8 percent. Sales in the first six months of 2019 were $361 million, 10 percent less than in same period of 2018.

Third quarter sales of Premarin (conjugated estrogens tablets, USP) family — $182 million, down 11%.

Data as of 12.27.19

About Premarin Horses

Premarin®, Prempro®, Premphase® and Duavee® are examples of the Premarin® family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products. Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are many alternatives.

Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

More Premarin Timelines

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THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2018

JULY 2018

In an article entitled, “Top 25 Pharma & BioPharma“, ContractPharma reports:

In 2018, Pfizer reported revenues of $53,647 billion, an increase of two percent. Premarin sales delivered $832 million to that total, with sales down -15%. END


In an article entitled, “Menopausal Hot Flashes Market is Rising to a Valuation of US$ 5,284.1 Mn in 2023,” OnlineNewsGuru.com reports:

Transparency Market Research has published a new market report titled, “Menopausal Hot Flashes Market — Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023.”

According to the report, the global menopausal hot flashes market was valued at US$3.77 bn in 2014 and is projected to expand at a CAGR of 3.7% from 2015 to 2023 to reach US$5.28 bn by 2023.

Hot flashes are the most common vasomotor symptom of menopause complications. The usual symptoms include sudden sensation of intense warmth spreading over body lasting for several minutes leading to sweating, red flush, and palpitations.

Hot flashes may occur during the day or at night (also known as night sweats). The intensity of hot flashes vary from woman to woman depending on several physiochemical factors. It may be mild, moderate and troublesome, or severe and debilitating.

Hormone replacement therapy (HRT) has been considered as gold standard for the treatment of menopausal hot flashes. However, long term HRT has an increased risk of breast cancer and risk associated with increasing age such as stroke, blood clots, and other health related problems.

Other therapies include intake of vitamin E supplements and anti-depressants along with various complementary therapies.

In the U.S. and other developed countries approximately 70% of menopausal women suffer from hot flashes that can last for several years. According to a publication by Harvard Medical School, on average, hot flashes can last for about 7 years to 11 years.


In an article entitled, “Pfizer Is Weighing Sale of $2 Billion-Women’s Health Portfolio“, Bloomberg reports:

•  U.S. drugmaker is gauging interest from potential buyers
•  Suitors likely to include private equity firms and drugmakers

Pfizer Inc. is reviewing options including a sale of its women’s health portfolio as the U.S. pharmaceutical giant seeks to focus on developing treatments with higher growth potential, according to people with knowledge of the matter.

The drugmaker is working with financial advisers to gauge the interest of potential buyers, the people said, asking not to be identified because the deliberations are private. A sale of the division, which has annual sales of roughly $1.2 billion, could fetch about $2 billion and draw bids from both private equity firms and rival pharmaceutical companies, they said.

A spokeswoman for Pfizer said the drugmaker declined to comment on speculation. No final decision has been reached and the company may yet decide to retain the assets, which include menopause treatments such as Premarin, Prempro and Premphase, the people said.

For more on Pfizer’s likely strategy under its new CEO, read this.

A divestment of the business would mean that Pfizer, which last month narrowed its full-year forecast amid manufacturing challenges within the business that makes its older medicines, is joining Allergan Plc and Teva Pharmaceutical Industries Ltd. in selling or winding down women’s health lines and shifting resources to other parts of their portfolios.

Allergan Chief Executive Officer Brent Saunders, who has been seeking to sell the firm’s women’s health and antibiotics divisions, this week said the offers so far have been below what the assets are worth. Last year, Teva opted to sell its women’s health division in separate transactions for about $2.5 billion as it raced to pay down debt. END.


Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.


Premarin, doctors and conjugated equine estrogens, Tuesday’s Horse, The Horse Fund (Oct. 8, 2018) »

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THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2017




AMAG Pharmaceuticals has big ambitions for its women’s health business, so it’s snapped up the rights to a new med, Intrarosa, to beef up that portfolio.

The company plans to tout Intrarosa’s safety profile to set it apart from established estrogen-based treatments such as Pfizer’s Premarin cream and Estring vaginal ring. The AMAG drug, which contains the hormone precursor prasterone, has a “similar efficacy profile,” CMO Julie Krop said this week. “[F]rom an efficacy standpoint, I don’t see that there is particularly differentiating advantage,” Krop said. “It’s really on the safety side”.

The company clearly sees big potential for Intrarosa. AMAG will pay Endoceutics $50 million up front, plus 600,000 shares of newly issued common stock, which closed Tuesday at $22.65. Follow-up sales milestones add up to $45 million if Intrarosa surpasses $300 million in sales over time. Read more at our blog Tuesday’s Horse »



A must read from our blog: New Study damns results of WHI report on Premarin family of drugs, by Jane Allin, Tuesday’s Horse (Oct. 10, 2017) »


Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

1686-1998 | 2001-2009 | 2010 | 2011 | 2012 | 2013 | 2014 | 2015 | 2016 | 2017 | 2018 | 2019

THF 2019 Logo. ©The Horse Fund.

Premarin Timeline 2016


Premarin horses (or PMU horses) are the mares and foals cruelly exploited to produce the Premarin® family of drugs made for the relief of menopausal symptoms in women.

The key component of these drugs comes from the estrogen rich urine collected from pregnant mares on what are commonly called “pee lines” in the industry.

PMU horses are purpose bred to produce Premarin® type drugs.

The resulting foals become unwanted byproducts and typically sold off at auction where they are in danger of being bought by “meat men” working on behalf of slaughterhouses. Some of these foals are shipped live to Japan to feed the highly popular sushi market.

Mares who can no longer become pregnant are also routinely cast off by the industry and exposed to the risk of slaughter.


In 2016 Horse Fund advocates and Tuesday’s Horse followers took more action and viewed and shared more articles and information on the Premarin® Horses issue than any other we work on.

You alerted us whenever you saw ads for Premarin® tablets or cream on television, in magazines and on YouTube. We contacted the advertisers and these ads were removed or not renewed, rarely appearing again. If they did resurface, you were on it and so were we.


The scientific term for the estrogen rich component contained in pregnant mare’s urine is conjugated equine estrogens (CEE’s).

With your help we were able to send out more than 33,000 Dear Doctor letters in 2016 warning physicians about the presence of CEE’s in the Premarin® family of drugs.


A bone of contention between us and certain doctors arose over labeling.

Notably, some years ago the word equine was removed from Premarin® packaging stating the drugs were made with conjugated estrogens.

This was done in spite of the fact that the World Health Organization declared that conjugated equine estrogens are known carcinogens — in other words they have cancer causing properties. In our opinion the US Food and Drug Administration (FDA) in this regard are operating in a dangerous and immoral manner by allowing the mislabeling of Premarin® in this way.

Conjugated estrogens can also be derived from plants. The core ingredient necessary to make Premarin® can only be derived from equines.

Yet there were doctors who continued to argue this point with us and said they had no problem prescribing Premarin®. In contradictory fashion some doctors even went so far as to defend the labeling stating that the FDA would not be so reckless with people’s lives.

However, it is crystal clear.

The key ingredient in the making of Premarin® type drugs is derived from pregnant mare’s urine. All you need to do is look at the name for proof — PREgnant MARe’s urINe.

We are pressing hard for the FDA to enforce correct labeling and will continue to do so. However in the current political climate it is likely to be tougher than ever.

By the way the Premarin® family of drugs includes Duavee® (originally named Aprela in all by the final stage of the FDA’s approval process) is an almost identical drug also made by Pfizer. But for reasons unknown they have marketed it very little in the US or abroad.

The largest market for Premarin® type drugs from available information is in China where they are producing what appears to be a copycat drug.


In 2012 Jane Allin performed her own independent research and discovered that there are indeed PMU horses in China. The use of the horses by the Chinese in this instance make their intent clear. See Pfizer consigns PMU horses to killing fields of Asia (Tuesday’s Horse).

It was not until 2016 we were able to show you what it looks like inside a “pee farm” in China. See A look at a PMU farm in China (Tuesday’s Horse). Here are a couple of images from that collection.

PMU Farm in Xinyuan County, China (2012).

PMU Farm in Xinyuan County, China (2012).

The Xinjiang Xinzi Biopharmaceutical Limited Liability Company reportedly uses the urine of pregnant mares as the source to successfully develop estrogen drugs, claiming they are one of two companies in the world doing this, the other being Wyeth and bought out by Pfizer.

Did Pfizer sell or make some sort of deal with the Chinese for the formula? Or did they have to considering the status of the drug’s patent?

Here is what it looks like inside one of the Chinese labs.

Inside the Xinjiang Xinzi Biopharmaceutical Company.

Another look inside the Xinjiang Xinzi Biopharmaceutical Company.

More from inside the Xinjiang Xinzi Biopharmaceutical Company.

Here is what Chinese packaging looks like for the copycat Premarin® vaginal cream.


The numbers are scary. The number of women reaching the menopausal stage in China is many millions more than any other place in the world.

It is up to us to warn them about the cancer causing properties connected to Premarin® type drugs. It is the only way we can help these horses. That is our mission for 2017.

Please remember.

Menopause is not a disease. Menopausal symptoms — although they can be most unpleasant and in some instances seem debilitating — are not life threatening and can be successfully treated.

No human or animal needs to be exposed to suffering or death in order to be provided with relief from menopausal symptoms. There are alternatives.


Premarin, Prempro, Premphase and Duavee are examples of the Premarin family of drugs which are made with the the estrogen rich urine of pregnant mares.

In the ‘pregnant mare urine’ (PMU) industry, horses are repeatedly impregnated so their urine can be collected and made into hormone replacement products . Some of the foals are rescued , but most are simply slaughtered and seen as a byproduct (much like male calves in the dairy industry).

There are alternatives. Talk to your doctor. Visit your local pharmacy. There are prescription free over-the-counter treatments for hot flashes, vaginal dryness and other menopausal symptoms. Thank you.

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