OSPEMIFENE Drug Patent Profile
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Which patents cover Ospemifene, and what generic alternatives are available?
Ospemifene is a drug marketed by Hetero Labs Ltd V and is included in one NDA.
The generic ingredient in OSPEMIFENE is ospemifene. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ospemifene profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ospemifene
A generic version of OSPEMIFENE was approved as ospemifene by HETERO LABS LTD V on February 13th, 2024.
Summary for OSPEMIFENE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 63 |
| Clinical Trials: | 10 |
| Patent Applications: | 301 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for OSPEMIFENE |
| 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 |
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 | ⤷ 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 |
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 |
