PREMPRO Drug Patent Profile

Which patents cover Prempro, and what generic alternatives are available?

Prempro is a drug marketed by Wyeth Pharms and Wyeth Pharms Inc and is included in two NDAs.

The generic ingredient in PREMPRO is estrogens, conjugated; medroxyprogesterone acetate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estrogens, conjugated; medroxyprogesterone acetate profile page.

Summary for PREMPRO

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	14
Drug Prices:	Drug price information for PREMPRO
What excipients (inactive ingredients) are in PREMPRO?	PREMPRO excipients list
DailyMed Link:	PREMPRO at DailyMed

See drug prices for PREMPRO

See drug sales revenues for PREMPRO

Recent Clinical Trials for PREMPRO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Pfizer	Phase 3
MDS Pharma Services	Phase 1
Bayer	Phase 2

See all PREMPRO clinical trials

Pharmacology for PREMPRO

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

US Patents and Regulatory Information for PREMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-005	Jun 4, 2003		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998		RX	Yes	Yes
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003		RX	Yes	Yes

Expired US Patents for PREMPRO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-001	Nov 17, 1995	RE36247
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-003	Jan 9, 1998	RE36247
Wyeth Pharms	PREMPRO	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020527-004	Mar 12, 2003	5,547,948

International Patents for PREMPRO

See the table below for patents covering PREMPRO around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	64407	Controlled release of steroids from sugar coatings
Denmark	165390
China	1141168

Supplementary Protection Certificates for PREMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	SPC/GB97/032	United Kingdom		SPC/GB97/032: 20040802, EXPIRES: 20090801
0136011	SPC/GB98/034	United Kingdom		SPC/GB98/034: 20040802, EXPIRES: 20090801
0136011	C00136011/03	Switzerland		PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417

PREMPRO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Prempro

Introduction

Prempro, a combination hormone therapy drug consisting of conjugated estrogens and medroxyprogesterone acetate, was once a blockbuster medication for menopausal symptoms. However, its market dynamics and financial trajectory have been significantly influenced by several key events, particularly the findings of the Women’s Health Initiative (WHI) study.

Rise to Prominence

Before the WHI study, Prempro, along with its sister drug Premarin, achieved widespread acceptance and generated over $2 billion in annual sales. Wyeth, the pharmaceutical company behind Prempro, aggressively marketed the drug, touting its benefits for various menopausal symptoms such as hot flashes, osteoporosis, and skin elasticity. The drug was heavily promoted through various channels, including direct-to-consumer advertising, free samples, and office-based detailing[4].

Impact of the Women’s Health Initiative (WHI) Study

The publication of the WHI study in July 2002 marked a significant turning point for Prempro. The study revealed that Prempro increased the risk of breast cancer, cardiovascular disease, thromboembolic events, and other health issues. This led to a rapid decline in prescriptions and promotional spending.

• Prescription Decline: Within nine months of the report’s publication, hormone therapy prescriptions decreased by 32%. By the fourth quarter of 2003, the use of Prempro had declined by 80%, from 4.4 million prescriptions in Q2 of 2002 to just 0.9 million prescriptions[1].
• Promotional Spending: There was a substantial reduction in promotional activities, with a 100% decrease in direct-to-consumer advertising and a 61% decrease in promotional spending for standard-dose Prempro by the first quarter of 2003[1].

Financial Consequences

The decline in prescriptions and promotional spending had significant financial implications for Wyeth and later Pfizer, which acquired Wyeth.

• Revenue Drop: The sales of Prempro and other hormone therapies plummeted following the WHI report. This led to a substantial decline in revenue for Wyeth and subsequently Pfizer[4].
• Legal and Settlement Costs: Over 10,000 women who developed estrogen-dependent breast cancers after taking Prempro filed lawsuits. These legal battles resulted in significant costs and settlements, further impacting the financial trajectory of the drug[4].

Shift to Lower-Dose Formulations

In response to the decline, pharmaceutical companies began promoting lower-dose formulations of Prempro and Premarin.

• New Promotional Strategies: By the latter part of 2003, promotional spending shifted towards lower-dose formulations, which saw modest increases in prescriptions. This strategy included new promotional expenditures of $13.5 million by the fourth quarter of 2003 for these lower-dose formulations[1].
• Market Adaptation: The introduction of lower-dose formulations was part of a broader strategy to adapt to the changing market landscape and mitigate the negative impact of the WHI study findings[1].

Current Market Status

While Prempro is no longer the blockbuster it once was, it still maintains a presence in the market, albeit with significantly reduced sales and a more cautious approach to promotion.

• Regulatory and Public Perception: The drug's reputation has been irreparably damaged by the WHI study findings, leading to stricter regulatory oversight and a more skeptical public perception[4].
• Competition and Alternatives: The market has seen the introduction of new treatments for menopausal symptoms, such as Imvexxy and Annovera, which have further eroded Prempro's market share[3].

Financial Performance of Pfizer

Pfizer, the current owner of Prempro, has seen significant fluctuations in its financial performance, partly due to the decline of Prempro and other factors such as the impact of COVID-19 products.

• Revenue Trends: Pfizer's revenues have been influenced by the decline of Prempro and other legacy products, as well as the rise and fall of COVID-19 related products like Comirnaty and Paxlovid. For example, in 2023, Pfizer reported a 42% decline in revenues compared to 2022, largely due to the decrease in sales of these COVID-19 products[2][5].

Key Takeaways

• The WHI study significantly impacted the market dynamics and financial trajectory of Prempro.
• The drug saw a rapid decline in prescriptions and promotional spending following the study's publication.
• Pharmaceutical companies adapted by promoting lower-dose formulations.
• The financial performance of Pfizer has been influenced by the decline of Prempro and other factors.
• The market has become more competitive with the introduction of new treatments for menopausal symptoms.

FAQs

What was the impact of the WHI study on Prempro prescriptions?

The WHI study led to a 32% decrease in hormone therapy prescriptions within nine months of its publication, with Prempro prescriptions declining by 80% by the fourth quarter of 2003[1].

How did the WHI study affect promotional spending for Prempro?

The study resulted in a substantial reduction in promotional activities, including a 100% decrease in direct-to-consumer advertising and a 61% decrease in promotional spending for standard-dose Prempro[1].

What was the financial impact on Wyeth and Pfizer due to the decline of Prempro?

The decline led to significant revenue drops and legal costs associated with lawsuits filed by women who developed breast cancer after taking Prempro[4].

How have pharmaceutical companies adapted to the decline of Prempro?

Companies have shifted their focus to promoting lower-dose formulations of Prempro and Premarin, which have seen modest increases in prescriptions[1].

What is the current market status of Prempro?

Prempro still exists in the market but with significantly reduced sales and a more cautious approach to promotion, facing competition from new treatments for menopausal symptoms[3].

How has Pfizer's financial performance been affected by the decline of Prempro?

Pfizer's revenues have been influenced by the decline of Prempro, as well as the impact of COVID-19 related products. The company reported a 42% decline in revenues in 2023 compared to 2022[2][5].

Sources

1. Promotion and Prescribing of Hormone Therapy After Report of the Women’s Health Initiative (WHI) Study - JAMA
2. Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance - Pfizer
3. Oppenheimer NDR_TXMD Final 3 - TherapeuticsMD Inc
4. Prempro - Hormone Replacement Therapy (HRT) - Hausfeld
5. PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES FULL-YEAR 2023 GUIDANCE - Pfizer