Sold as Revlimid. Every FDA application for this active ingredient: 1 branded and 20 generic.
As of Nov 13, 2026, FDA lists 21 applications for Lenalidomide (sold as Revlimid), first approved Dec 27, 2005, with 8 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2024 | Change | Beneficiaries |
|---|---|---|---|---|
| Revlimid | Part D | $4.18B | +8% | 38,868 |
| Lenalidomide | Part D | $2.64B | +57% | 30,354 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 27, 2005 | RevlimidNDA 21880 ยท New molecular entity | Bristol Myers Squibb | 38 | Marketed |
| Aug 30, 2022 | LenalidomideANDA 209348 | Dr Reddys | 4 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 201452 | Arrow Intl | 5 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 210154 | Zydus Pharms | 3 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 210435 | Cipla | 2 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 210480 | Alvogen | 2 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 211846 | Sun Pharm | 2 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 213885 | Eugia Pharma | 2 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 213912 | Mylan | 2 | Marketed |
| Mar 6, 2023 | LenalidomideANDA 214618 | Cipla | 2 | Marketed |
| Mar 7, 2023 | LenalidomideANDA 211022 | Apotex | 2 | Marketed |
| May 11, 2023 | LenalidomideANDA 212414 | Hetero Labs Ltd V | 1 | Marketed |
| Aug 3, 2023 | LenalidomideANDA 213405 | Torrent | 2 | Discontinued |
| Feb 22, 2024 | LenalidomideANDA 217265 | Qilu | 1 | Marketed |
| Sep 11, 2024 | LenalidomideANDA 217281 | Novugen | 1 | Marketed |
| Jan 31, 2025 | LenalidomideANDA 216213 | Amneal | 1 | Marketed |
| Mar 3, 2025 | LenalidomideANDA 215759 | Biocon Pharma | 1 | Marketed |
| May 22, 2025 | LenalidomideANDA 217554 | Deva Holding As | 1 | Marketed |
| Sep 16, 2025 | LenalidomideANDA 214398 | Lupin | 1 | Marketed |
| Nov 14, 2025 | LenalidomideANDA 218872 | Accord Hlthcare | 1 | Marketed |
| Feb 2, 2026 | LenalidomideANDA 213165 | Cipla | 1 | Marketed |
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. Drugs@FDA