OSPEMIFENE Drug Patent Profile
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 is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ospemifene profile page.
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Questions you can ask:
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Summary for OSPEMIFENE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 11 |
| Patent Applications: | 589 |
| 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 |
|---|---|
| Tongji Hospital | EARLY_PHASE1 |
| Hospital Clinic of Barcelona | Phase 4 |
| Emory University | 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 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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/002780Senshio 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 |
