PREMPRO (PREMARIN;CYCRIN) Drug Patent Profile

Which patents cover Prempro (premarin;cycrin), and when can generic versions of Prempro (premarin;cycrin) launch?

Prempro (premarin;cycrin) is a drug marketed by Wyeth Pharms Inc and is included in one NDA.

The generic ingredient in PREMPRO (PREMARIN;CYCRIN) 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 (PREMARIN;CYCRIN)

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	72
DailyMed Link:	PREMPRO (PREMARIN;CYCRIN) at DailyMed

US Patents and Regulatory Information for PREMPRO (PREMARIN;CYCRIN)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994		DISCN	No	No

Expired US Patents for PREMPRO (PREMARIN;CYCRIN)

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994
Wyeth Pharms Inc	PREMPRO (PREMARIN;CYCRIN)	estrogens, conjugated; medroxyprogesterone acetate	TABLET;ORAL-28	020303-001	Dec 30, 1994

International Patents for PREMPRO (PREMARIN;CYCRIN)

See the table below for patents covering PREMPRO (PREMARIN;CYCRIN) around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	165390
Greece	3029620
Finland	115915

Supplementary Protection Certificates for PREMPRO (PREMARIN;CYCRIN)

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 (PREMARIN;CYCRIN) Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of PREMPRO (and Related Drugs like PREMARIN)

Introduction

PREMPRO, a hormone replacement therapy (HRT) drug, along with its sister drug PREMARIN, has had a significant impact on the pharmaceutical market, particularly in the treatment of menopausal symptoms. Here, we will explore the market dynamics and financial trajectory of these drugs, highlighting key events, regulatory changes, and their effects on sales and public perception.

Rise to Prominence

In the late 1990s and early 2000s, PREMPRO and PREMARIN gained widespread acceptance and achieved "blockbuster" status, with sales exceeding $2 billion annually. Wyeth, the pharmaceutical company behind these drugs, aggressively marketed them to menopausal women and their healthcare providers, touting benefits such as the alleviation of hot flashes, osteoporosis, and other menopause-related symptoms[4].

Marketing Strategies

Wyeth's marketing efforts were extensive and included celebrity endorsements, direct-to-consumer advertising, and targeted sales campaigns to obstetricians and gynecologists. The company also published scientific papers, often ghostwritten by Wyeth but attributed to respected doctors, to reinforce the benefits of these drugs[4].

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

The landscape changed dramatically with the publication of the Women's Health Initiative (WHI) study in July 2002. The study revealed that PREMPRO increased the risk of breast cancer, cardiovascular disease, thromboembolic events, and other health issues. This led to a swift and significant decline in prescriptions and promotional spending for hormone therapies, particularly for standard-dose PREMPRO and PREMARIN[1].

Decline in Prescriptions

Following the WHI report, hormone therapy prescriptions declined sharply. By the first quarter of 2003, there was a 32% decrease in hormone therapy prescriptions compared to the second quarter of 2002. Specifically, the use of standard-dose PREMPRO decreased by 64% between the second quarter of 2002 and the first quarter of 2003, and by 80% by the fourth quarter of 2003[1].

Reduction in Promotional Spending

Promotional spending for hormone therapies also plummeted. Direct-to-consumer advertising for standard-dose PREMPRO ceased entirely, and overall promotional spending decreased by 82% from $19.4 million in the second quarter of 2002 to $3.5 million by the fourth quarter of 2003[1].

Shift to Lower-Dose Formulations

In response to the declining sales and negative publicity, pharmaceutical companies began promoting lower-dose formulations of PREMPRO and PREMARIN. These newer formulations saw modest increases in prescriptions and promotional spending. By the fourth quarter of 2003, promotional expenditures for lower-dose formulations had reached $13.5 million, indicating a strategic shift towards these products[1].

Regulatory and Labeling Changes

The FDA approved new indications and dosing regimens for PREMARIN, including the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. These changes were reflected in updated labeling and prescribing information, highlighting the risks and benefits associated with estrogen therapy[2][3].

Litigation and Public Backlash

The revelation of increased health risks associated with PREMPRO led to a wave of lawsuits. Over 10,000 women who developed estrogen-dependent breast cancers after taking PREMPRO filed lawsuits against Wyeth. These cases were consolidated into a multi-district litigation (MDL), resulting in significant settlements and damages awarded to the plaintiffs. The legal battles highlighted Wyeth's aggressive marketing practices and the company's efforts to downplay the risks of the drug[4].

Financial Impact

The financial trajectory of PREMPRO and PREMARIN was severely impacted by the WHI study and subsequent litigation. Sales plummeted, and Wyeth's stock price suffered significantly. Despite the introduction of lower-dose formulations, the drugs never regained their pre-WHI market dominance. The financial losses were compounded by the costs associated with litigation and settlements[1][4].

Current Market Status

Today, while PREMPRO and PREMARIN are still prescribed for menopausal symptoms, their use is much more cautious and regulated. The FDA has updated labeling to reflect the risks associated with these drugs, and healthcare providers are more diligent in weighing the benefits against the potential harms. The market for HRT has evolved, with a greater emphasis on personalized treatment plans and alternative therapies[2][3].

Key Takeaways

• Market Impact of WHI Study: The publication of the WHI study led to a significant decline in prescriptions and promotional spending for PREMPRO and PREMARIN.
• Shift to Lower-Dose Formulations: Pharmaceutical companies responded by promoting lower-dose formulations, which saw modest increases in prescriptions.
• Regulatory Changes: Updated labeling and prescribing information reflect the risks and benefits associated with estrogen therapy.
• Litigation and Public Backlash: Aggressive marketing practices and downplayed risks led to extensive litigation and financial losses.
• Current Market Status: The use of PREMPRO and PREMARIN is more cautious, with a greater emphasis on personalized treatment plans and alternative therapies.

FAQs

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

The WHI study led to a 32% decline in hormone therapy prescriptions by the first quarter of 2003, with a 64% decline in standard-dose PREMPRO prescriptions between Q2 of 2002 and Q1 of 2003[1].

How did promotional spending change after the WHI study?

Promotional spending for hormone therapies decreased by 82% from $19.4 million in Q2 of 2002 to $3.5 million by Q4 of 2003, with a complete cessation of direct-to-consumer advertising for standard-dose PREMPRO[1].

What new indications were approved for PREMARIN?

The FDA approved new indications for PREMARIN, including the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause[2].

How many lawsuits were filed against Wyeth due to PREMPRO?

Over 10,000 women filed lawsuits against Wyeth after developing estrogen-dependent breast cancers while taking PREMPRO[4].

What is the current status of PREMPRO and PREMARIN in the market?

The use of PREMPRO and PREMARIN is more cautious, with updated labeling reflecting the risks and benefits, and a greater emphasis on personalized treatment plans and alternative therapies[2][3].

Sources

1. Promotion and Prescribing of Hormone Therapy After Report of the Women's Health Initiative - JAMA
2. Supplemental New Drug Application for Premarin Vaginal Cream - FDA
3. PREMPRO (conjugated estrogens/medroxyprogesterone acetate) Label - FDA
4. Prempro - Hormone Replacement Therapy (HRT) - Hausfeld