Treats moderate to severe dyspareunia. Sold as Osphena. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 14, 2026, FDA lists 2 applications for Ospemifene (sold as Osphena), first approved Feb 26, 2013, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Osphena | Part D | $7.6M | -3% | 4,259 |
| Feb 26, 2013 | OsphenaNDA 203505 · New molecular entity | Duchesnay | 16 | Marketed |
| Feb 13, 2024 | OspemifeneANDA 215574 | Hetero Labs Ltd V | 2 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
