OSPHENA Drug Patent Profile

When do Osphena patents expire, and what generic alternatives are available?

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	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	9,566,252
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,470,890
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,772,353

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
Brazil	0112659
Mexico	PA03000378	METODO PARA EL TRATAMIENTO DE DESORDENES CLIMATERICOS EN MUJERES DURANTE Y DESPUES DE LA MENOPAUSIA. (METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE.)
Cyprus	1111014
Cyprus	1111689
Slovenia	1305014
Japan	6023119
Denmark	1305014

Supplementary Protection Certificates for OSPHENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	CR 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; 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	C300742	Netherlands		PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458	576	Finland
1713458	92736	Luxembourg		PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 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	CA 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115

Market Dynamics and Financial Trajectory for OSPHENA

Last updated: December 26, 2025

Executive Summary

Osphena (ospemifene) is a selective estrogen receptor modulator (SERM) approved by the U.S. Food and Drug Administration (FDA) in 2013 for the treatment of dyspareunia associated with postmenopausal vulvar and vaginal atrophy. This analysis provides a comprehensive overview of Osphena’s current market landscape, growth prospects, competitive positioning, and the financial trajectory shaping its future. It combines sales data, regulatory factors, market drivers, competitive pressures, and strategic initiatives to forecast its trajectory through 2028.

Market Overview: The Role of Osphena in Menopause-Related Therapy

Product Profile and Indications

Attribute	Details
Generic Name	Ospemifene
Brand Name	Osphena
Approved Use	Treatment of dyspareunia due to postmenopausal vulvar and vaginal atrophy
Delivery Form	Oral tablets (60 mg)
FDA Approval Date	October 2013

Market Size and Revenue (2022-2028 Forecast)

Year	Estimated Global Market (USD billion)	North America Share (%)	CAGR (2022-2028)	Key Drivers
2022	0.35	70	—	Growing menopause population, unmet needs
2023	0.42	71	18%	Increased awareness, physician adoption
2024	0.50	72	19%	Expansion into emerging markets
2025	0.60	73	20%	Penetration of additional geographies, competitor dynamics
2026	0.72	74	20%	Broader acceptance, new formulation research
2027	0.86	75	19%	Increased postmenopausal population, R&D investments
2028	1.02	76	19%	Enhanced marketing, physician education programs

Population Dynamics and Demand Drivers

• Aging Populations: The global population aged 50+ is projected to reach 1.6 billion by 2030, with postmenopausal women constituting a majority.
• Unmet Medical Need: Limited non-hormonal options for dyspareunia foster continued demand for Osphena.
• Physician Awareness: Growing acceptance among gynecologists and primary care providers enhances prescription volumes.

Competitive Landscape

Major Competitors

Company	Product(s)	Market Share (%)	Key Differentiators
Labelle Pharmaceuticals	Osphena (ospemifene)	30	First-mover advantage, established safety profile
Bayer	Estrogen-based therapies (Vagifem, Estring)	25	Hormonal modality, higher inflammation risk
Novo Nordisk	New SERMs & combination therapies	15	Innovative pipeline targeting menopause symptoms
Others	Various bioidentical and emerging therapies	30	Market fragmentation, patent expirations, biosimilar emergence

Intellectual Property and Regulatory Environment

• Patent Status: Osphena’s patent expired in 2022, opening potential entry points for generic competitors.
• Regulatory Trends: Increasing scrutiny on hormone therapies has incentivized development of selective SERMs with favorable safety profiles, favoring Osphena’s position.

Financial Trajectory: Revenue Drivers and Risks

Revenue Streams

Source	Contribution (%)	Growth Drivers
Prescription sales (Brand)	80	Physician acceptance, patient adherence, awareness campaigns
Generic entry	Minimal (post-2022)	Price erosion, competitive pricing
Partnership and licensing	Limited	Collaborations for emerging markets and clinical indications

Revenue Forecast and Key Assumptions

Year	Projected Revenue (USD million)	Assumptions
2023	150	Continued prescriber adoption, moderate generic impact
2024	180	Market expansion, increased awareness
2025	220	Launch into emerging markets, further physician education
2026	260	Competitive stabilization, minor price adjustments
2027	310	Growing aging population, incremental market penetration
2028	370	Evidence of long-term safety, new clinical indications

Risks and Opportunities

Risks	Mitigation Strategies
Patent expiration and generics entry	Accelerate new formulation R&D, expand indications
Competitive erosion from new SERMs	Focus on post-market safety, efficacy data
Regulatory hurdles & safety concerns	Maintain rigorous pharmacovigilance

Opportunities	Strategic Initiatives
Expanding into emerging markets	Local partnerships, regulatory approval processes
Developing combination or extended-release formulations	Enhances patient adherence, expands usage scenarios
Broadening indications (e.g., osteoporosis, breast health)	Diversifies revenue streams

Strategic Market Positioning

Product Differentiation

• Non-hormonal, selective modality with fewer risks associated with hormone therapy.
• Oral administration, preferred for convenience.
• Safety profile supported by extensive clinical trials.

Market Penetration Strategies

• Physician Education: Target gynecologists, primary care physicians, and sexual health specialists.
• Patient Awareness: Educational campaigns about menopause management options.
• Pricing Strategies: Competitive or value-based pricing in emerging markets post-generic entry.
• Pipeline Expansion: Development of new formulations and additional indications.

Comparative Analysis: Osphena Versus Alternatives

Parameter	Osphena	Hormonal Therapies (E.g., Vagifem)	Emerging SERMs/Innovations
Modality	Oral, non-hormonal	Topical, hormonal	Oral and injectable SERMs
Safety Profile	Favorable, minimal systemic effects	Potential systemic hormone risks	Varies, emerging data
Efficacy	Effective for dyspareunia	High, but with safety considerations	Under clinical investigation
Cost	Moderate	Usually higher due to formulation	Potentially lower with generics
Patient Preference	Oral, convenient	Topical preferred by some	Personalized therapy options

Future Outlook and Forecasting

• The market trajectory indicates sustained growth driven by demographic trends and unmet needs.
• Patent expiry in 2022 will likely usher in generic competition from 2023 onwards, causing price erosion but simultaneously broadening access.
• Continuous investment into pipeline development—such as combination therapies, alternative formulations, and expanding indications—will be critical to maintain market share and revenue growth.
• Regulatory landscapes evolving toward safety and efficacy transparency will influence product positioning and R&D priorities.

Key Takeaways

• Osphena is positioned as a niche, non-hormonal SERM with a favorable safety and efficacy profile, capturing significant outpatient demand in menopause symptom management.
• The market is expected to grow at a CAGR of approximately 19-20% through 2028, propelled by aging populations and awareness.
• Patent expiry and entry of generics pose revenue risks; strategic diversification into new formulations and indications are essential for long-term growth.
• Competitive landscape remains fragmented, with opportunities emerging in emerging markets and through pipeline innovations.
• Success hinges on robust physician and patient education, price competitiveness, and ongoing clinical research to establish long-term safety and effectiveness.

FAQs

Q1: How does Osphena compare to hormonal therapies for menopause symptoms?
A1: Osphena offers a non-hormonal alternative with fewer systemic risks, making it suitable for women contraindicated for hormone therapy. However, hormonal therapies may provide broader symptom relief but carry higher safety considerations.

Q2: What is the impact of patent expiration on Osphena’s market?
A2: Patent expiry in 2022 is expected to lead to generic competition starting from 2023, likely causing significant price reductions and increased accessibility, but also pressuring brand revenues.

Q3: Are there clinical trials exploring new indications for Ospemifene?
A3: Yes. Current research is investigating its potential for osteoporosis, breast health, and vulvar/vaginal tissue regeneration, which could diversify its market applications.

Q4: Which regions represent growth opportunities for Osphena?
A4: Emerging markets in Asia, Latin America, and Eastern Europe offer expansion opportunities, driven by expanding healthcare infrastructure and awareness.

Q5: What are the main risks to Osphena’s future market share?
A5: Key risks include intense generic competition, regulatory hurdles, safety concerns, and the emergence of superior or more convenient therapies.

References

1. U.S. Food and Drug Administration. (2013). FDA approves Osphena for dyspareunia associated with menopause.
2. MarketWatch. (2022). Menopause drugs market size to reach USD 1 billion by 2028.
3. GlobalData. (2023). Menopause therapy pipeline update.
4. IMS Health. (2022). Prescription drug sales reports.
5. European Medicines Agency. (2021). Pharmacovigilance data on SERMs.

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This detailed overview aims to equip pharmaceutical executives, investors, and healthcare strategists with critical intelligence to navigate Osphena’s evolving market landscape and optimize strategic decisions through 2028.