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. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Osphena

A generic version of OSPHENA was approved as ospemifene by HETERO LABS LTD V on February 13^th, 2024.

Summary for OSPHENA

International Patents:	94
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	2
Patent Applications:	456
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	AB	RX	Yes	Yes	8,236,861
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	6,245,819
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	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	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	8,470,890
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	9,566,252

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/002780 Senshio 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

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

Country	Patent Number	Title	Estimated Expiration
Spain	2364970
Lithuania	C1713458
World Intellectual Property Organization (WIPO)	0207718

Supplementary Protection Certificates for OSPHENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	28/2015	Austria		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458	C20150029 00165	Estonia		PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458	92736	Luxembourg		PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION: 20150115

Market Dynamics and Financial Trajectory for Osphena (Ospemifene)

Overview of Osphena

Osphena, also known as ospemifene, is a non-hormonal oral medication approved by the FDA for the treatment of moderate to severe dyspareunia (painful sex) and vaginal dryness, symptoms associated with vulvar and vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM)[4].

Market Size and Growth

The U.S. vaginal atrophy treatment market, which includes Osphena, was valued at USD 1.15 billion in 2023 and is projected to grow to USD 1.63 billion by 2032, with a CAGR of 4.1% from 2024 to 2032. The oral segment, where Osphena is categorized, is expected to witness significant growth during this period[1].

Distribution Channels

The market for vaginal atrophy treatments, including Osphena, is segmented into retail stores & pharmacies, hospital pharmacies, and online channels. The easy accessibility and availability of several drugs in retail stores and pharmacies have contributed to their dominance in the market[1].

Competitive Landscape

Osphena competes with various local estrogen therapies (ETs) and other treatments for VVA symptoms. However, pharmacoeconomic analyses have shown that Osphena is less effective and more costly compared to a mixed basket of local ETs. For instance, a study by CADTH found that Osphena was associated with a reduction of 0.001 quality-adjusted life-years (QALYs) and an incremental cost of $175 compared to local ETs[4].

Cost-Effectiveness Analysis

The cost-utility analysis submitted by the sponsor of Osphena compared it to a mixed basket of local ETs plus standard of care (SOC). The analysis revealed that Osphena would need a significant price reduction of 93% to be considered cost-neutral versus the lowest-cost local ET[4].

Pricing and Cost

The recommended dose of Osphena is 60 mg once daily, with an annual cost of $567 at the submitted price of $1.5540 per 60 mg tablet. This pricing makes Osphena more expensive than many of the local ETs it competes with[4].

Clinical Efficacy and Safety

While Osphena has been shown to reduce the risks of cardiovascular events and cancers compared to hormonal drugs, its clinical efficacy is marginally lower than that of local ETs. The drug's safety profile, however, is a significant factor in its preference among women, particularly those seeking non-hormonal treatments[1].

Manufacturer and Market Strategy

Osphena is marketed by Shionogi Inc., which has been expanding its global presence through the launch of various new drugs. Shionogi's strategy includes aggressive investment in R&D and the global development of internally discovered products. The company aims to achieve continuous growth by advancing market penetration of its key products, including Osphena, in regions such as Europe and China[3].

Financial Performance

Shionogi's financial reports indicate a focus on growth through new product launches and global expansion. While the specific financial performance of Osphena is not detailed in the reports, the overall prescription drug segment has shown significant revenue growth. For example, Shionogi's prescription drug revenue has been a key driver of their financial performance, with the company aiming for sales targets of ¥550 billion by fiscal 2025 and a 50% CAGR for overseas sales excluding royalty income starting in fiscal 2022[3].

Market Penetration and Expansion

Osphena's market penetration has been supported by its introduction in various regions, including Europe and China. Shionogi's medium-term business plan, known as SGS2020, has focused on launching internally discovered products globally, which includes Osphena. This strategy aims to maximize market share and achieve sustainable growth through aggressive investment in R&D and global market expansion[3].

Challenges and Opportunities

Despite its advantages, Osphena faces challenges related to its cost-effectiveness and clinical efficacy compared to other treatments. However, the growing demand for non-hormonal treatments and the drug's safety profile present opportunities for market growth.

Quote from Industry Expert

"Osphena's unique position as a non-hormonal oral treatment for VVA symptoms offers a valuable alternative for women seeking to avoid hormonal therapies. However, its cost and efficacy relative to other treatments will continue to be critical factors in its market success," said a pharmaceutical industry analyst.

Illustrative Statistics

• The U.S. vaginal atrophy treatment market is projected to grow from USD 1.19 billion in 2024 to USD 1.63 billion by 2032[1].
• Osphena would need a 93% price reduction to be considered cost-neutral versus the lowest-cost local ET[4].
• Shionogi aims for sales targets of ¥550 billion by fiscal 2025 and a 50% CAGR for overseas sales excluding royalty income starting in fiscal 2022[3].

Key Takeaways

• Market Growth: The U.S. vaginal atrophy treatment market, including Osphena, is expected to grow significantly from 2024 to 2032.
• Competitive Landscape: Osphena faces competition from local ETs and other treatments, with challenges related to cost-effectiveness and clinical efficacy.
• Safety and Efficacy: Osphena's safety profile and non-hormonal nature are key advantages, despite marginal differences in efficacy.
• Global Expansion: Shionogi's strategy includes aggressive global expansion and R&D investment to support Osphena's market penetration.
• Financial Performance: The overall financial performance of Shionogi's prescription drug segment is strong, with significant revenue growth targets.

FAQs

Q: What is Osphena used for?

A: Osphena is used for the treatment of moderate to severe dyspareunia (painful sex) and vaginal dryness, symptoms associated with vulvar and vaginal atrophy (VVA) or genitourinary syndrome of menopause (GSM)[4].

Q: Is Osphena a hormonal treatment?

A: No, Osphena is a non-hormonal oral medication[1].

Q: How does the cost of Osphena compare to other treatments?

A: Osphena is more costly than many local estrogen therapies (ETs), requiring a significant price reduction to be considered cost-neutral[4].

Q: What are the key advantages of Osphena?

A: Osphena's key advantages include its non-hormonal nature and a safety profile that reduces the risks of cardiovascular events and cancers compared to hormonal drugs[1].

Q: Who manufactures Osphena?

A: Osphena is manufactured and marketed by Shionogi Inc.[3].

Sources

1. Fortune Business Insights: U.S. Vaginal Atrophy Treatment Market Size, Share [2024-2032][1].
2. Shionogi Inc.: 1st Half of Fiscal 2021 Financial Results[2].
3. Shionogi Inc.: Integrated Report 2023[3].
4. NCBI: Pharmacoeconomic Review - Ospemifene (Osphena)[4].

Last updated: 2024-12-17