Ospemifene - Generic Drug Details

What are the generic drug sources for ospemifene and what is the scope of patent protection?

Ospemifene is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V and Duchesnay, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are six drug master file entries for ospemifene. One supplier is listed for this compound.

Summary for ospemifene

International Patents:	94
US Patents:	3
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	59
Clinical Trials:	11
Patent Applications:	1,048
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ospemifene
What excipients (inactive ingredients) are in ospemifene?	ospemifene excipients list
DailyMed Link:	ospemifene at DailyMed

Recent Clinical Trials for ospemifene

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

Sponsor	Phase
Tongji Hospital	EARLY_PHASE1
Hospital Clinic of Barcelona	Phase 4
Emory University	Phase 4

See all ospemifene clinical trials

Pharmacology for ospemifene

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

Anatomical Therapeutic Chemical (ATC) Classes for ospemifene

G03XC	Selective estrogen receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for OSPEMIFENE

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

US Patents and Regulatory Information for ospemifene

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hetero Labs Ltd V	OSPEMIFENE	ospemifene	TABLET;ORAL	215574-001	Feb 13, 2024		DISCN	No	No
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	8,642,079		Y
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes	8,236,861

Expired US Patents for ospemifene

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

EU/EMA Drug Approvals for ospemifene

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 ospemifene

Country	Patent Number	Title	Estimated Expiration
Denmark	1713458
Germany	60112301
Cyprus	1111014

Supplementary Protection Certificates for ospemifene

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	122015000048	Germany		PRODUCT NAME: OSPEMIFEN; REGISTRATION 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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OSPEMIFENE

Last updated: July 28, 2025

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Introduction

OSPEMIFENE, a selective estrogen receptor modulator (SERM), presents promising therapeutic potential primarily in the fields of osteoporosis prevention and breast cancer treatment. As a novel compound in the pharmaceutical pipeline, its market trajectory is influenced by clinical efficacy, regulatory pathways, competitive landscape, and healthcare trends. This report analyzes critical market dynamics and forecasts OSPEMIFENE’s financial outlook, providing strategic insights for stakeholders.

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Therapeutic Indications and Clinical Development

OSPEMIFENE targets postmenopausal osteoporosis and hormone receptor-positive breast cancer, aligning with prevailing healthcare priorities. Market approval hinges on demonstrating superior safety and efficacy profiles compared to existing SERMs like tamoxifen and raloxifene. Several clinical trials are underway, emphasizing bone mineral density (BMD) improvements and reduced fracture risk, alongside favorable safety data [1].

Pending successful clinical milestones, OSPEMIFENE could achieve regulatory approval within 3-5 years, contingent on jurisdiction-specific review processes. Notably, the drug’s development aligns with global efforts to address the rising incidence of osteoporosis—affecting over 200 million women worldwide—and breast cancer, which accounts for approximately 15% of all cancers in women [2].

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Market Size and Growth Drivers

Global Osteoporosis Market

The osteoporosis therapeutics market is projected to reach USD 15.75 billion by 2027, with a compound annual growth rate (CAGR) of approximately 3.5% [3]. The aging population drives this expansion, as women over 50 are at heightened risk.

Breast Cancer Market

The global breast cancer drugs market is estimated to surpass USD 20 billion by 2025, bolstered by increased awareness and advances in targeted therapies [4].

Key Growth Drivers

• Aging Demographics: The increasing global female demographic over 50 enhances demand.
• Regulatory Incentives: Orphan drug designation and fast-track approvals can accelerate market entry.
• Efficacy and Safety Gains: Potential superior profiles over current SERMs could secure market share.
• Healthcare Policy Shifts: Emphasis on preventative care favors early intervention drugs like OSPEMIFENE.

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Competitive Landscape

OSPEMIFENE faces competition from established SERMs such as:

• Raloxifene: Approved for osteoporosis and breast cancer risk reduction.
• Tamoxifen: Long-standing agent in breast cancer treatment.
• Bazedoxifene: Approved for osteoporosis, with additional benefits.

Emerging drugs and biosimilars also threaten market share. However, OSPEMIFENE’s unique molecular design could confer differentiation through improved tissue selectivity or reduced adverse effects, essential for capturing clinician and patient preference.

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Regulatory and Reimbursement Outlook

Regulatory agencies like the FDA and EMA scrutinize safety data rigorously, especially regarding thromboembolic events and endometrial health—common concerns with SERMs.

Reimbursement landscapes depend on regional health policies and cost-effectiveness data. Demonstrating reduced fracture incidence or breast cancer risk can facilitate favorable formulary decisions, especially if OSPEMIFENE demonstrates cost benefits compared to current standards.

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Pricing Strategy and Revenue Projections

Initial pricing of OSPEMIFENE will likely reflect its perceived clinical advantage, with premium positioning possible if it offers significant safety or efficacy improvements.

Revenue Modeling:

• Year 1-2: Limited sales as the drug gains regulatory approval and penetrates key markets.
• Year 3-5: Rapid growth anticipated post-market entry, driven by expanding indications and formulary inclusion.
• Long-term: Market saturation achieved as generic competitors emerge around patent expiry, typically 8-12 years post-launch.

Assuming moderate market penetration—around 10-15% of the target population within five years—gross revenues could reach USD 1-2 billion cumulatively over a decade, considering pricing and market share dynamics [5].

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Intellectual Property and Commercialization Strategies

Patent protection remains vital for maximized revenues. Securing composition-of-matter patents, method-of-use, and formulation patents will shield OSPEMIFENE against generic competition. Strategic alliances with large pharmaceutical companies can facilitate global distribution and marketing.

Furthermore, pursuing orphan drug designation or similar incentives can improve financial returns by extending exclusivity and reducing development costs.

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Risks and Challenges

• Clinical Trial Failures: Suboptimal efficacy or safety concerns could delay or prevent approval.
• Regulatory Delays: Stringent review processes may extend timelines.
• Market Competition: Existing SERMs with established safety profiles may hinder uptake.
• Pricing and Reimbursement Barriers: Payer negotiations can limit revenue potential.
• Intellectual Property Challenges: Patent disputes may impact exclusivity.

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Conclusion and Strategic Implications

The market potential for OSPEMIFENE remains robust, driven by demographic trends and unmet needs. Success hinges on demonstrating clinical advantages, navigating regulatory pathways efficiently, and executing effective commercialization strategies.

Stakeholders should prioritize accelerating clinical trials, strengthening patent protections, and engaging early with regulatory agencies. Diversifying indications to include other estrogen-related conditions may further bolster long-term revenue streams.

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Key Takeaways

• Market Opportunity: OSPEMIFENE targets substantial markets in osteoporosis and breast cancer, with global revenues forecasted to grow steadily.
• Development Milestones: Timely clinical trial success and regulatory approval are critical for unlocking market potential.
• Competitive Advantage: Differentiation via safety and efficacy improvements can secure market share over existing SERMs.
• Pricing and Reimbursement: Innovation-driven value propositions enable premium pricing, subject to health policy landscapes.
• Risk Management: Vigilant clinical development, patent strategy, and stakeholder engagement are vital to mitigate potential barriers.

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FAQs

1. When is OSPEMIFENE expected to reach the market?
Pending successful clinical outcomes and regulatory approval, OSPEMIFENE could enter markets within 3-5 years.

2. How does OSPEMIFENE compare to existing SERMs?
OSPEMIFENE aims to exhibit improved tissue selectivity, minimized adverse effects, and enhanced safety profiles over current SERMs like raloxifene and tamoxifen.

3. What are the primary regulatory considerations?
Regulatory agencies require comprehensive safety, efficacy, and risk data, particularly regarding thromboembolism, endometrial safety, and long-term outcomes.

4. What is the revenue outlook for OSPEMIFENE?
Potential revenues could reach USD 1-2 billion annually within five years post-launch, assuming successful market penetration and pricing strategies.

5. What strategic steps should stakeholders take to maximize OSPEMIFENE’s market success?
Stakeholders must focus on completing robust clinical trials, securing patent protection, engaging early with regulators, and developing a compelling value proposition to payers and clinicians.

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References

[1] ClinicalTrials.gov. “OSPEMIFENE Clinical Trial Reports.”
[2] International Osteoporosis Foundation. “Osteoporosis Facts and Figures,” 2022.
[3] Research and Markets. “Global Osteoporosis Market Forecast,” 2022.
[4] Grand View Research. “Breast Cancer Drugs Market Analysis,” 2022.
[5] EvaluatePharma. “Pharmaceutical Revenue Projections,” 2022.