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OSPHENA Drug Profile

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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 eight patents protecting this drug.

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.

US ANDA Litigation and 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.

Indicators of Generic Entry

Summary for OSPHENA

International Patents:	94
US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	48
Clinical Trials:	2
Patent Applications:	44
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OSPHENA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSPHENA
DailyMed Link:	OSPHENA at DailyMed

See drug prices for OSPHENA

Generic Entry Opportunity 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

US Patents and Regulatory Information for 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
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

International Patents for OSPHENA

Country	Patent Number	Estimated Expiration
Luxembourg	92736
Cyprus	1111014
Russian Federation	2423113
Slovenia	1713458
Bulgaria	107472

Supplementary Protection Certificates for OSPHENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C20150029 00165	Estonia		PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
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	1590030-1	Sweden		PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119