FDA Orange Book · active-ingredient family
Ospemifene
Ospemifene is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OSPHENA · NDA 203505
1
Brand (NDA)
1
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OSPHENARLD | DUCHESNAY | NDA 203505 | — | Feb 26, 2013 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OSPEMIFENE | HETERO LABS LTD V | ANDA 215574 | — | Feb 13, 2024 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8236861 | Aug 11, 2026 | in 2 mo | U-905 |
| 8642079 | Jul 09, 2028 | in 2 yr 1 mo | Product |
Ospemifene — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
