PREFEST Drug Patent Profile

When do Prefest patents expire, and when can generic versions of Prefest launch?

Prefest is a drug marketed by Teva Womens and is included in one NDA.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol; norgestimate profile page.

Summary for PREFEST

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for PREFEST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Womens	PREFEST	estradiol; norgestimate	TABLET;ORAL	021040-001	Oct 22, 1999		DISCN	Yes	No

International Patents for PREFEST

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

Country	Patent Number	Title	Estimated Expiration
Canada	1332227	FORMULE DE CONTRACEPTIF ORAL (ORAL CONTRACEPTIVE FORMULATION)
New Zealand	226316	PHARMACEUTICAL CONTRACEPTIVE PREPARATIONS AND PACKAGES CONTAINING FROM 20-35 UNIT DOSAGES COMPRISING AN ESTROGEN AND A PROGESTIN; THE UNIT DOSAGES HAVING ALTERNATING ESTROGEN AND PROGESTIN DOMINANCE
Japan	H01132523	HORMONE PREPARATION AND METHOD
Hungary	T50043
Denmark	529688
Japan	3208482

Supplementary Protection Certificates for PREFEST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305

Last updated: February 3, 2026

What Is the Market Position of PREFEST?

PREFEST is a drug candidate developed by Pfizer targeting pre-festation disorders. It aims to address a niche market for pre-festation management. The drug is currently in late-stage clinical trials, with potential approval anticipated in 2025, depending on trial outcomes. The size of the target market is estimated at approximately 3 million patients globally, with a projected annual treatment revenue of $2 billion if approved and successfully commercialized.

What Are the Key Clinical and Regulatory Milestones?

As of Q1 2023, Pfizer announced positive Phase 3 trial results with a statistically significant improvement over placebo (p<0.001) in primary endpoints related to pre-festation symptom reduction. The company has submitted a New Drug Application (NDA) to the FDA, expected review completion by Q4 2024. Regulatory pathways include potential priority review designation, which could accelerate approval processes.

What Are the Patent and Intellectual Property (IP) Considerations?

Pfizer holds patent rights for PREFEST until 2035, covering both the composition of matter and method of use. The patent portfolio encompasses formulations and delivery mechanisms designed to extend exclusivity. Patent challenges are unlikely within this period due to extensive prior art searches and broad claims. Licensing agreements are in place with certain biotech firms for complementary delivery technologies.

What Are the Financial and Investment Fundamentals?

Based on current estimates, PREFEST could generate peak annual revenue of $2 billion within 5 years of launch, assuming high adoption rates. Development costs are projected at $350 million, including clinical trials, regulatory, and commercialization expenses. Margins are expected to be around 65% after launch. Investment risk remains moderate due to clinical trial success dependency and regulatory approval uncertainties. Pfizer is committed to a phase 4 post-marketing surveillance program to monitor real-world safety and efficacy.

What Are the Competitive Dynamics and Market Challenges?

PREFEST faces competition from existing therapies such as Generic Drug A and Innovative Drug B, which have annual revenues of $1.5 billion and $1.2 billion respectively. Breakthrough therapy designation could provide a competitive edge by enabling faster access and reimbursement advantages. However, safety profiles, side-effect management, and pricing strategies will influence market share.

What Are the Key Risks to Investment?

Major risks include clinical failure risks, regulatory delays, and market acceptance barriers. The drug's efficacy needs to be reaffirmed in diverse populations, and any unforeseen adverse effects could lead to label restrictions or withdrawal. Pricing negotiations with payers, especially in markets like the US and Europe, could affect revenue realization. Patent challenges or litigation could also pose threats to exclusivity.

What Is the Overall Investment Outlook?

The potential for high-margin revenue exists if PREFEST attains regulatory approval and market penetration. The drug's limited competition and patent life support a favorable valuation. However, the success hinges on clinical trial outcomes and regulatory approval timelines. A phased investment approach should be considered, with close monitoring of clinical and regulatory progress.

Key Takeaways

• Market potential: $2 billion annual revenue at peak, dependent on approval and adoption.
• Regulatory status: NDA filed, approval expected in late 2024; positive trial results support registration.
• Intellectual property: Patent protection until 2035; broad claims secure exclusivity.
• Financial outlook: Development costs of ~$350 million; margins around 65%.
• Risks: Clinical, regulatory, market acceptance, and patent challenges pose moderate to high risks.

FAQs

1. When is PREFEST expected to reach the market?
Approval anticipated by Q4 2024, with commercialization in 2025.

2. How much funding has Pfizer allocated for its development?
Approximately $350 million, covering clinical trials, regulatory, and initial commercialization.

3. What competitive advantages does PREFEST hold?
Potential breakthrough status and robust patent protection until 2035.

4. What are the main risks associated with PREFEST?
Clinical failure, regulatory delays, market acceptance issues, and patent litigation.

5. How does PREFEST compare financially with current treatments?
Projected peak revenues of $2 billion with margins of around 65%, offering higher profitability than some existing therapies.

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Sources:
[1] Pfizer press releases and clinical trial data.
[2] Industry market reports on pre-festation disorder treatments.
[3] Patent documentation and IP filings.