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Generated: June 19, 2019

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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-two 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.

Drug patent expirations by year for OSPHENA
Generic Entry Opportunity Date for OSPHENA
Generic Entry Date for OSPHENA*:
Constraining patent/regulatory exclusivity:
NDA:
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
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Duchesnay OSPHENA ospemifene TABLET;ORAL 203505-001 Feb 26, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for OSPHENA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1713458 PA2015023 Lithuania ➤ Sign Up PRODUCT NAME: OSPEMIFENUM; REGISTRATION NO/DATE: EU/1/14/978/001, 2015 01 15 EU/1/14/978/002 20150115
1713458 1590030-1 Sweden ➤ Sign Up PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119
1713458 PA2015023,C1713458 Lithuania ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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