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 seven 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^® Generic Entry Outlook for Osphena

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 9, 2028. This may change due to patent challenges or generic licensing.

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.

There is one tentative approval for the generic drug (ospemifene), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for OSPHENA

International Patents:	94
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	2
Patent Applications:	364
Formulation / Manufacturing:	see details
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OSPHENA

NDA:

203505

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Anatomical Therapeutic Chemical (ATC) Classes for OSPHENA

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 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 eighteen US patents.

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

Patents protecting OSPHENA

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
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes			Y
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013		RX	Yes	Yes

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

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

When does loss-of-exclusivity occur for OSPHENA?

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

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Japan

Mexico

Norway

Poland

Portugal

Russian Federation

Slovenia

Spain

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	1713458
Mexico	PA06009274	METODO PARA MEJORAR LA BIODISPONIBILIDAD DEL OSPEMIFENO. (METHOD FOR ENHANCING THE BIOAVAILABILITY OF OSPEMIFENE.)
Hungary	229361	METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE
Germany	602005005165

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	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	C20150029 00165	Estonia		PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015