Ospemifene - Generic Drug Details
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What are the generic drug sources for ospemifene and what is the scope of patent protection?
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 |
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 |
Pharmacology for ospemifene
Drug Class | Estrogen Agonist/Antagonist |
Mechanism of Action | Selective Estrogen Receptor Modulators |
Anatomical Therapeutic Chemical (ATC) Classes for ospemifene
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hetero Labs Ltd V | OSPEMIFENE | ospemifene | TABLET;ORAL | 215574-001 | Feb 13, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | AB | 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 |
Expired US Patents for ospemifene
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
Duchesnay | OSPHENA | ospemifene | TABLET;ORAL | 203505-001 | Feb 26, 2013 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ospemifene
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
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 329954 | ⤷ Sign Up | |
Lithuania | PA2015023 | ⤷ Sign Up | |
Slovenia | 1713458 | ⤷ Sign Up | |
China | 1953741 | Solid formulations of ospemifene | ⤷ Sign Up |
South Africa | 200300342 | Method for the treatment of climacteric disorders in women during or after the menopause. | ⤷ Sign Up |
Spain | 2302177 | ⤷ Sign Up | |
Portugal | 1305014 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ospemifene
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1713458 | 122015000048 | Germany | ⤷ Sign Up | PRODUCT NAME: OSPEMIFEN; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115 |
1713458 | 576 | Finland | ⤷ Sign Up | |
1713458 | C20150029 00165 | Estonia | ⤷ Sign Up | PRODUCT NAME: OSPEMIFEEN;REG NO/DATE: EU/1/14/978 19.01.2015 |
1713458 | CA 2015 00031 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSPEMIFENE; REG. NO/DATE: EU/1/14/978/001-002 20150115 |
1713458 | 132016000023047 | Italy | ⤷ Sign Up | PRODUCT NAME: OSPEMIFENE IN TUTTE LE FORME PROTETTE DAL BREVETTO DI BASE(SENSHIO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/978/001-002, 20150115 |
1713458 | 2015/031 | Ireland | ⤷ Sign Up | PRODUCT NAME: OSPEMIFENE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF; REGISTRATION NO/DATE: EU/1/14/978/001-002 20150115 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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