OSPEMIFENE - Generic Drug Details

What are the generic drug sources for ospemifene and what is the scope of freedom to operate?

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 seven 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. Two suppliers are listed for this compound.

Summary for OSPEMIFENE

International Patents:	94
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	10
Patent Applications:	583
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
Hospital Clinic of Barcelona	Phase 4
Emory University	Phase 4
Sue Goldstein	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
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	9,855,224
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,236,861
Hetero Labs Ltd V	OSPEMIFENE	ospemifene	TABLET;ORAL	215574-001	Feb 13, 2024	AB	RX	No	No
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	9,241,915
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,772,353
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	8,642,079		Y

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	9,855,224
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
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

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/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 OSPEMIFENE

Country	Patent Number	Title	Estimated Expiration
China	1953741	Solid formulations of ospemifene
Denmark	1305014
Poland	1718288
Luxembourg	92736
Japan	2007522190
Russian Federation	2675624	ТВЕРДЫЕ ПРЕПАРАТИВНЫЕ ФОРМЫ ОСПЕМИФЕНА (SOLID FORMULATIONS OF OSPEMIFENE)

Supplementary Protection Certificates for OSPEMIFENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	576	Finland
1713458	PA2015023	Lithuania		PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458	122015000048	Germany		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
1713458	15C0041	France		PRODUCT NAME: OSPEMIFENE DANS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; REGISTRATION NO/DATE: EU/1/14/978 20150115
1713458	CA 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115

OSPEMIFENE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ospemifene

Introduction

Ospemifene, marketed under the brand name Osphena, is a selective estrogen receptor modulator (SERM) used to treat moderate to severe dyspareunia (painful intercourse) and vaginal dryness in postmenopausal women. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth

The U.S. vaginal atrophy treatment market, in which ospemifene is a key player, was valued at $1.15 billion in 2023 and is projected to grow to $1.63 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 4.1% during the forecast period[1].

Segment Dominance

Route of Administration

The market is segmented into oral, parenteral, and topical routes of administration. The oral segment, where ospemifene is categorized, is expected to witness lucrative growth. Ospemifene is the only FDA-approved non-hormonal oral drug for treating vaginal atrophy symptoms, which contributes to its increasing demand[1].

Distribution Channels

The market is also segmented by distribution channels, including retail stores & pharmacies, hospital pharmacies, and online channels. Retail stores & pharmacies dominate this segment due to the easy accessibility and availability of several drugs, including ospemifene[1].

Key Growth Drivers

Increasing Prevalence of Vaginal Atrophy

The rising prevalence of vaginal atrophy among postmenopausal women is a significant driver for the growth of the ospemifene market. As the population ages, the demand for effective treatments for menopausal symptoms is increasing[1].

Innovations and Advancements

Continuous innovations and advancements in treatment options, including the development of SERMs like ospemifene, are driving market growth. These innovations offer patients more choices and better outcomes, contributing to the market's expansion[1].

Competitive Landscape

Leading Players

Pfizer, Inc. and AbbVie are among the leading players in the U.S. vaginal atrophy treatment market. The presence of these major pharmaceutical companies ensures significant investment in research, marketing, and distribution, which helps in maintaining and growing the market share of ospemifene[1].

Clinical Efficacy and Safety

Clinical Trials

Ospemifene has been evaluated in several clinical trials, including five phase III, double-blind, placebo-controlled studies. These trials have demonstrated statistically significant improvements in the severity of vaginal dryness and dyspareunia compared to placebo. However, the drug is associated with notable harms in rare cases, such as deep vein thrombosis and arterial thromboembolic disease[3].

Side Effects and Contraindications

Ospemifene is associated with various side effects, including vaginal bleeding, headaches, and increased sweating. It is contraindicated in patients with estrogen-dependent neoplasia, active or history of blood clots, heart attack, stroke, and severe liver disease. These factors must be considered by healthcare providers when prescribing the drug[5].

Economic Considerations

Cost-Effectiveness

At the current manufacturer-submitted price, ospemifene is more costly and less effective compared to local estrogen therapies. A significant price reduction, estimated at 93%, would be required for ospemifene to be considered cost-neutral to the lowest cost local estrogen therapy[3].

Market Trends

Estrogen Receptor Modulators Market

Ospemifene is part of the broader estrogen receptor modulators (ERMs) market, which is experiencing growth driven by the unique benefits of SERMs. The ERM market is segmented by drugs, indications, end-users, and distribution channels, with ospemifene showing the highest CAGR within this market[4].

Patient and Healthcare Provider Perspectives

Patient Input

Patients who have used ospemifene report mixed experiences, with some benefiting from the treatment while others experience significant side effects. Patient input questionnaires highlight symptoms such as mild irritation and discomfort, which are common in vaginal atrophy[3].

Healthcare Provider Recommendations

Healthcare providers must carefully evaluate the benefits and risks of ospemifene, considering the patient's medical history and current health conditions. Regular follow-up visits and blood tests are recommended to monitor the drug's efficacy and potential side effects[5].

Financial Projections

Given the projected growth of the U.S. vaginal atrophy treatment market and the specific growth trajectory of the oral segment, ospemifene is expected to contribute significantly to the market's financial performance. However, its cost-effectiveness compared to other treatments, such as local estrogen therapies, remains a critical factor that could influence its financial trajectory.

Key Takeaways

• Market Growth: The U.S. vaginal atrophy treatment market, including ospemifene, is expected to grow at a CAGR of 4.1% from 2024 to 2032.
• Segment Dominance: The oral segment, where ospemifene is categorized, is expected to witness significant growth.
• Clinical Efficacy: Ospemifene has shown efficacy in clinical trials but is associated with notable harms and side effects.
• Economic Considerations: Ospemifene is currently more costly and less effective than local estrogen therapies, requiring a significant price reduction to be cost-neutral.
• Market Trends: The ERM market, including ospemifene, is driven by the unique benefits of SERMs.

FAQs

What is ospemifene used for?

Ospemifene is used to treat moderate to severe dyspareunia (painful intercourse) and vaginal dryness in postmenopausal women.

What are the common side effects of ospemifene?

Common side effects include vaginal bleeding, headaches, increased sweating, and muscle spasms. Less common but serious side effects include blood clots, strokes, and heart attacks.

Is ospemifene more effective than local estrogen therapies?

At the current price, ospemifene is less effective and more costly than local estrogen therapies. A significant price reduction would be needed for it to be considered cost-neutral.

Who are the leading players in the U.S. vaginal atrophy treatment market?

Pfizer, Inc. and AbbVie are among the leading players in this market.

What is the projected market size for the U.S. vaginal atrophy treatment market by 2032?

The market is projected to reach $1.63 billion by 2032, growing at a CAGR of 4.1% from 2024 to 2032.

Sources

1. Fortune Business Insights: U.S. Vaginal Atrophy Treatment Market Size, Share [2024-2032]
2. Drugs.com: Ospemifene Alternatives Compared
3. Gov.bc.ca: ospemifene (Osphena) 3828 DDS
4. Market Research Future: Estrogen Receptor Modulators Market Size, Share, Trends 2032
5. Mayo Clinic: Ospemifene (oral route) - Mayo Clinic