OSPHENA Drug Patent Profile

Which patents cover Osphena, and when can generic versions of Osphena launch?

Osphena is a drug marketed by Duchesnay and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has ninety-four patent family members in thirty-one countries.

The generic ingredient in OSPHENA is ospemifene. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.

DrugPatentWatch^® Generic Entry Outlook for Osphena

Osphena was eligible for patent challenges on February 26, 2017.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for OSPHENA

International Patents:	94
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	2
Drug Prices:	Drug price information for OSPHENA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSPHENA
What excipients (inactive ingredients) are in OSPHENA?	OSPHENA excipients list
DailyMed Link:	OSPHENA at DailyMed

See drug prices for OSPHENA

Recent Clinical Trials for OSPHENA

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

Sponsor	Phase
Emory University	Phase 4
Sue Goldstein	Phase 4

See all OSPHENA clinical trials

Pharmacology for OSPHENA

Drug Class	Estrogen Agonist/Antagonist
Mechanism of Action	Selective Estrogen Receptor Modulators

Paragraph IV (Patent) Challenges for OSPHENA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OSPHENA	Tablets	ospemifene	60 mg	203505	1	2020-12-29

US Patents and Regulatory Information for OSPHENA

OSPHENA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	8,236,861
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	6,245,819
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	8,642,079		Y

Expired US Patents for OSPHENA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,566,252
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	6,245,819
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,855,224
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,772,353
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,470,890

EU/EMA Drug Approvals for OSPHENA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Shionogi B.V.	Senshio	ospemifene	EMEA/H/C/002780Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.	Authorised	no	no	no	2015-01-14

International Patents for OSPHENA

When does loss-of-exclusivity occur for OSPHENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Norway

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OSPHENA around the world.

Country	Patent Number	Title	Estimated Expiration
Portugal	1718288
Norway	20030273
Mexico	PA06009546	FORMULACIONES SOLIDAS DE OSPEMIFENO. (SOLID FORMULATIONS OF OSPEMIFENE.)
Bulgaria	107472
Austria	E506054
Japan	5629746
Germany	602005005165

Supplementary Protection Certificates for OSPHENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	PA2015023	Lithuania		PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458	PA2015023,C1713458	Lithuania		PRODUCT NAME: OSPEMIFENAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458	CA 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458	132016000023047	Italy		PRODUCT NAME: OSPEMIFENE IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(SENSHIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/978/001-002, 20150115
1713458	2015/031	Ireland		PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458	122015000048	Germany		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458	216 5010-2015	Slovakia		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug Osphena

Last updated: July 27, 2025

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Introduction

Osphena (ospemifene), an oral selective estrogen receptor modulator (SERM), received approval from the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of dyspareunia, a symptom of vulvar and vaginal atrophy due to menopause. With a unique mechanism targeting postmenopausal women suffering from painful intercourse, Osphena fits into a niche but growing segment of hormone-related therapies. Analyzing its market dynamics and financial trajectory reveals key trends, opportunities, and challenges shaping its commercial prospects.

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Market Overview and Demand Drivers

The global menopause market, anticipated to reach approximately USD 18 billion by 2025 [1], underpins the potential for Osphena. The increasing aging female population globally, especially in North America and Europe, sustains demand for hormone therapy options addressing menopausal symptoms.

Osphena's primary indication for dyspareunia due to menopause addresses an underserved market segment, particularly given the limitations and safety concerns associated with traditional estrogen therapies. Unlike systemic estrogen treatments, Osphena's selective action offers a potentially safer alternative, which is attractive to both physicians and patients.

Growing Awareness and Treatment Acceptance

Increased recognition of sexual health issues among postmenopausal women and the stigma surrounding menopausal symptoms have driven demand. Moreover, patient preference for oral medications over topical or invasive procedures furthers Osphena’s market accessibility.

Competitive Landscape

Osphena faces competition from hormonal and non-hormonal therapies:

• Hormone Replacement Therapy (HRT): Traditional estrogen-based therapies, though effective, face safety concerns, limiting their use.
• Vaginal Estrogen Products: These locally administered therapies (e.g., creams, rings) compete by offering targeted symptom relief but may lack the convenience or systemic benefits of Osphena.
• Non-Hormonal Solutions: Emerging treatments and lifestyle interventions are gradually gaining traction but remain limited in scope.

Pharmaceutical giants like Pfizer and Novo Nordisk have explored similar therapies, yet Osphena maintains a foothold due to its unique oral administration and favorable safety profile.

Market Penetration and Adoption

Initial post-approval years saw modest uptake, primarily driven by regulatory approval, physician awareness, and reimbursement policies. Key factors influencing adoption include:

• Physician Prescribing Habits: Gynecologists and menopause specialists are primary prescribers. Educational initiatives are critical in expanding awareness.
• Insurance Coverage: Reimbursement policies significantly affect access; coverage disparities across regions impact sales volume.
• Safety Perceptions: Perception of safety relative to other hormonal therapies influences prescribing behavior further.

Despite its niche positioning, Osphena’s penetration remains moderate, with global sales predominantly concentrated within the United States.

Financial Trajectory: Revenue Streams and Growth Potential

Initial Sales and Growth Trends

From launch in 2013, Osphena experienced gradual revenue growth. Pfizer’s reported sales figures indicated revenues of approximately USD 150–200 million annually in recent years, although these figures have shown fluctuations subject to market penetration, competitive pressures, and internal strategic shifts.

Revenue Drivers

• Market Expansion: Increasing prescriber base and geographic expansion bolster revenue.
• Label Expansion: FDA label modifications indicating broader indications could enhance market opportunity.
• Pricing Strategies: Competitive pricing and reimbursement negotiations influence sales volume.

Pipeline and Lifecycle Management

Pfizer’s strategic investments in lifecycle management—such as potential label extensions or combination therapies—could sustain or elevate revenue streams. Ongoing trial data exploring efficacy, safety, and comparative effectiveness will inform future marketing and regulatory actions.

Market Challenges and Risks

• Regulatory and Safety Concerns: Post-marketing safety signals or adverse event reports may impact market confidence and sales.
• Competitive Innovation: The emergence of alternative therapies, especially non-hormonal options, can diminish Osphena’s market share.
• Pricing Pressures: Cost containment initiatives by payers could restrict reimbursement levels.
• Off-Label Use and Prescriber Hesitancy: Limited familiarity or skepticism among physicians may hinder widespread adoption.

Emerging Trends Influencing Future Market Trajectory

• Digital Health and Patient Engagement: Digital platforms facilitating education and adherence could improve market penetration.
• Personalized Medicine: Biomarker-driven approaches might identify subpopulations more likely to benefit, optimizing sales.
• Global Expansion: Markets in Europe, Asia, and Latin America are unmapped territories with growth potential, contingent on regulatory approvals and strategic partnerships.

Financial Outlook and Forecasts

Industry analysts project a compound annual growth rate (CAGR) of approximately 4-6% for the postmenopausal treatment segment over the next five years [2]. With targeted efforts, Osphena could capitalize on this trend, potentially reaching USD 300 million to USD 500 million globally by 2028, depending on adoption rates, label expansions, and competition.

Additionally, Pfizer’s broader strategic initiatives, including lifecycle management and pipeline diversification, will influence Osphena's long-term valuation. The recent pivots towards digital health and patient-centered models are expected to further shape revenue streams.

Conclusion

Osphena's market dynamics are shaped by demographic trends, evolving treatment paradigms, and competitive forces. Its financial trajectory hinges on market expansion, prescriber acceptance, and strategic lifecycle management. While it capitalizes on a niche but expanding segment of menopausal therapy, challenges remain from safety concerns, regulatory pressures, and competitive innovations.

Proactive market engagement, continued clinical research, and potential indication extensions will be critical to optimizing its long-term financial outlook.

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Key Takeaways

• Growing Demographic: The aging female population ensures sustained demand for menopause-related therapies, underpinning Osphena’s market potential.
• Strategic Positioning: Osphena’s oral administration offers advantages over local therapies, but market adoption requires enhanced physician education and reimbursement navigation.
• Competitive Landscape: Shifts towards non-hormonal treatments and safety concerns surrounding hormone therapies present ongoing challenges.
• Revenue Expectation: Moderate growth projected, with potential to expand through geographic and indication expansion, contingent on regulatory and clinical support.
• Market Risks: Safety issues, payer pressures, and emerging competitors necessitate vigilant lifecycle management and innovation.

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FAQs

1. What is Osphena’s primary mechanism of action?
Osphena acts as a selective estrogen receptor modulator (SERM), agonizing estrogen receptors in vaginal tissue to alleviate atrophic symptoms and acting as an antagonist in other tissues to reduce risks associated with systemic estrogen therapy.

2. How does Osphena differ from traditional hormone replacement therapies?
Unlike systemic estrogen therapies, Osphena specifically targets vaginal tissues, offering a localized treatment with a potentially better safety profile, and is administered orally, improving patient compliance.

3. What are the main barriers to Osphena’s market growth?
Barriers include safety concerns, limited physician familiarity, reimbursement challenges, and competition from both hormonal and non-hormonal alternatives.

4. Are there ongoing clinical trials that could impact Osphena’s future?
Yes. Ongoing studies evaluating efficacy in broader indications, safety, and comparative effectiveness may support label expansions and market growth.

5. What strategic steps can Pfizer take to enhance Osphena’s market trajectory?
Pfizer can focus on clinician education, expand geographic approvals, pursue label extensions, and engage in partnerships facilitating access in emerging markets.

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References

[1] MarketResearch.com, "Menopause Market Size & Trends," 2021.
[2] EvaluatePharma, "Pharmaceutical Industry Forecast," 2022.