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OSPHENA Drug Profile

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When do Osphena patents expire, and what generic alternatives are available?

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:	46
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

Recent Litigation for OSPHENA

Identify potential future generic entrants

PTAB Litigation

Petitioner	Date
	2013-08-19

See all OSPHENA litigation

Pharmacology for OSPHENA

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

Synonyms for OSPHENA

(Z)-2-(4-(4-chloro-1,2-diphenylbut-1-en-1-yl)phenoxy)ethan-1-ol

128607-22-7

2-(4-(4-chloro-1,2-diphenyl-but-1-enyl)phenoxy)ethanol

2-(p-((Z)-4-Chloro-1,2-diphenyl-1-butenyl)phenoxy)ethanol

2-[4-[(Z)-4-chloro-1,2-di(phenyl)but-1-enyl]phenoxy]ethanol

2-[4-[(Z)-4-chloro-1,2-diphenylbut-1-enyl]phenoxy]ethanol

2-{4-[(1Z)-4-chloro-1,2-diphenylbut-1-en-1-yl]phenoxy}ethanol

2617AH

AC-27645

AC1MI19T

AKOS025401964

B0P231ILBK

BCP20981

C24H23ClO2

CCRIS 9205

CHEBI:73275

CHEMBL2105395

CS-5961

D08958

DB04938

Deamino-hydroxytoremifene

Deaminohydroxytoremifene

Deaminotoremifene

Ethanol, 2-[4-[(1Z)-4-chloro-1,2-diphenyl-1-buten-1-yl]phenoxy]-

Ethanol, 2-[4-[(1Z)-4-chloro-1,2-diphenyl-1-butenyl]phenoxy]-

Ethanol,2-[4-[(1Z)-4-chloro-1,2-diphenyl-1-buten-1-yl]phenoxy]-

Fc-1271

FC-1271a

GTPL7349

HSDB 8281

HY-B0723

J-005613

LUMKNAVTFCDUIE-VHXPQNKSSA-N

MolPort-006-170-032

O0441

Ophena

Ospemifene

Ospemifene (INN/USAN/BAN)

Ospemifene [USAN:INN:BAN]

Osphena (TN)

s4285

SCHEMBL948118

senshio

SW219657-1

UNII-B0P231ILBK

Z-2-[4-(4-chloro-1,2-diphenyl-but-1-enyl)-phenoxy]-ethanol

ZINC1550766

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

International Patents for OSPHENA

Country	Patent Number	Estimated Expiration
South Korea	100880564
Russian Federation	2268035
Poland	1713458
Bulgaria	107472
Cyprus	1111014

Supplementary Protection Certificates for OSPHENA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	PA2015023	Lithuania		PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458	CA 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458	216 5010-2015	Slovakia		PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978 20150119
1713458	CR 2015 00031	Denmark		PRODUCT NAME: OSPEMIFENE OR A GEOMETRIC ISOMER THEREOF, A STEREOISOMER THEREOF, A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AN ESTER THEREOF OR A METABOLITE THEREOF; REG. NO/DATE: EU/1/14/978/001-002 20150115
1713458	122015000048	Germany		PRODUCT NAME: OSPEMIFEN IN ALLEN DEM GRUNDPATENT ZUGRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115