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Last Updated: April 27, 2024

OSPEMIFENE - Generic Drug Details

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What are the generic drug sources for ospemifene and what is the scope of freedom to operate?

Ospemifene is the generic ingredient in two branded drugs marketed by Hetero Labs Ltd V and Duchesnay, and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ospemifene has ninety-four patent family members in thirty-one countries.

There are six drug master file entries for ospemifene. Two suppliers are listed for this compound.

Summary for OSPEMIFENE

International Patents:	94
US Patents:	7
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	10
Patent Applications:	582
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSPEMIFENE
What excipients (inactive ingredients) are in OSPEMIFENE?	OSPEMIFENE excipients list
DailyMed Link:	OSPEMIFENE at DailyMed

Recent Clinical Trials for OSPEMIFENE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital Clinic of Barcelona	Phase 4
Emory University	Phase 4
Sue Goldstein	Phase 4

See all OSPEMIFENE clinical trials

Pharmacology for OSPEMIFENE

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

Paragraph IV (Patent) Challenges for OSPEMIFENE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OSPHENA	Tablets	ospemifene	60 mg	203505	1	2020-12-29

US Patents and Regulatory Information for OSPEMIFENE

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Glossary

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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	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hetero Labs Ltd V	OSPEMIFENE	ospemifene	TABLET;ORAL	215574-001	Feb 13, 2024	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OSPEMIFENE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Try a Trial	⤷ Try a Trial
Duchesnay	OSPHENA	ospemifene	TABLET;ORAL	203505-001	Feb 26, 2013	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for OSPEMIFENE

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Shionogi B.V.	Senshio	ospemifene	EMEA/H/C/002780 Senshio is indicated for the treatment of moderate to severe symptomatic vulvar and vaginal atrophy (VVA) in post-menopausal women.	Authorised	no	no	no	2015-01-14
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for OSPEMIFENE

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Country	Patent Number	Title	Estimated Expiration
Czech Republic	299439	Použití (deaminohydroxy)toremifenu pro lécbu klimakterických onemocnení u žen behem menopauzy nebo po menopauze (Use of (deaminohydroxy)toremifene for treating climacteric diseases in women during menopause or after menopause)	⤷ Try a Trial
South Korea	20030048378		⤷ Try a Trial
Slovenia	1718288		⤷ Try a Trial
Russian Federation	2268035	СПОСОБ ЛЕЧЕНИЯ КЛИМАКТЕРИЧЕСКИХ РАССТРОЙСТВ У ЖЕНЩИН ВО ВРЕМЯ ИЛИ ПОСЛЕ МЕНОПАУЗЫ (METHOD FOR TREATING CLIMACTERIC DISORDERS IN WOMEN EITHER DURING OR AFTER MENOPAUSE)	⤷ Try a Trial
Norway	20064262		⤷ Try a Trial
Croatia	P20030024		⤷ Try a Trial
Canada	2416480	PROCEDE DE TRAITEMENT DE TROUBLES CLIMATERIQUES CHEZ LES FEMMES DURANT OU APRES LA MENOPAUSE (METHOD FOR THE TREATMENT OF CLIMACTERIC DISORDERS IN WOMEN DURING OR AFTER THE MENOPAUSE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OSPEMIFENE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1713458	PA2015023,C1713458	Lithuania	⤷ Try a Trial	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	⤷ Try a Trial	PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015
1713458	28/2015	Austria	⤷ Try a Trial	PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150119
1713458	1590030-1	Sweden	⤷ Try a Trial	PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/14/978/001 20150119
1713458	576	Finland	⤷ Try a Trial
1713458	SPC/GB15/035	United Kingdom	⤷ Try a Trial	PRODUCT NAME: OSPEMIFENE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/14/978/001 20150115; UK EU/1/14/978/002 20150115
1713458	CA 2015 00031	Denmark	⤷ Try a Trial	PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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