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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.

The generic ingredient in OSPHENA is ospemifene. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.

Summary for OSPHENA

US Patents:	8
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	41
Clinical Trials:	2
Patent Applications:	41
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for OSPHENA
DailyMed Link:	OSPHENA at DailyMed

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.

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

C24H23ClO2

CCRIS 9205

CHEBI:73275

CHEMBL2105395

CS-5961

D02CTS

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

OR071014

OR212015

Ospemifene

Ospemifene (INN/USAN/BAN)

Ospemifene [USAN:INN:BAN]

OSPEMIFENE; 2-[P-[(Z)-4-CHLORO-1,2-DIPHENYL-1-BUTENYL]PHENOXY]ETHANOL

Osphena (TN)

s4285

SCHEMBL948118

senshio

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

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Non-Orange Book US Patents for OSPHENA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,984,665	Methods for the inhibition of atrophy or for treatment or prevention of atrophy-related symptoms in women

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International Patents for OSPHENA

Country	Document Number	Estimated Expiration
Czech Republic	20030026
Russian Federation	2423113
New Zealand	524181
European Patent Office	1305014

Supplementary Protection Certificates for OSPHENA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
15/031	Ireland		PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115
00742	Netherlands		PRODUCT NAME: OSPEMIFEEN, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH; REGISTRATION NO/DATE: EU/1/14/978 20150115
2015023,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
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