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OSPEMIFENE

ANDA

OSPEMIFENE | A215574 | HETERO LABS LTD UNIT V

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Duchesnay Inc. et al v. Hetero Labs Limited et al 1:2021cv00538 1 patentANDA 215574ospemifene	D. Del.	2021-04-14	Terminated 2021-11-17	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain7 active DMFs1 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

FERMION OYOSPEMIFENE

DMF 255412011

OLON SPAOSPEMIFENE

DMF 297202015

TIANJIN WEIJIE PHARMACEUTICAL CO LTDOSPEMIFENE

DMF 304742016

ALIVUS LIFE SCIENCES LTDOSPEMIFENE

DMF 305742016

HONOUR LAB LTDOSPEMIFENE

DMF 308582016

SHIONOGI INCOSPEMIFENE

DMF 358772021

MAITHRI DRUGS PRIVATE LTDOSPEMIFENE

DMF 386602023

CAMBREX KARLSKOGA ABInactiveOSPEMIFENE

DMF 311632018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 60MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Feb 13, 2024

No patent or exclusivity listings for this strength.