NINTEDANIB Drug Patent Profile
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Which patents cover Nintedanib, and what generic alternatives are available?
Nintedanib is a drug marketed by Apotex, Biocon Pharma, Cipla, Dexcel, Dr Reddys, Glenmark Pharms Ltd, Humanwell Puracap, Macleods Pharms, and Sandoz. and is included in nine NDAs.
The generic ingredient in NINTEDANIB is nintedanib esylate. There is one drug master file entry for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nintedanib esylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nintedanib
A generic version of NINTEDANIB was approved as nintedanib esylate by APOTEX on April 2nd, 2026.
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Questions you can ask:
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Summary for NINTEDANIB
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 9 |
| DailyMed Link: | NINTEDANIB at DailyMed |
Pharmacology for NINTEDANIB
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
US Patents and Regulatory Information for NINTEDANIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219227-001 | Apr 2, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sandoz | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 216915-002 | Apr 2, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dexcel | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219819-001 | Apr 2, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Biocon Pharma | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 220118-002 | Aug 19, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Glenmark Pharms Ltd | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 212555-002 | Jul 9, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dexcel | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219819-002 | Apr 2, 2026 | AB | RX | 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 |
