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, Cipla, Dexcel, Dr Reddys, Humanwell Puracap, and Sandoz. and is included in six NDAs.
The generic ingredient in NINTEDANIB is nintedanib esylate. There are nine drug master file entries for this compound. Nine 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:
- What is the 5 year forecast for NINTEDANIB?
- What are the global sales for NINTEDANIB?
- What is Average Wholesale Price for NINTEDANIB?
Summary for NINTEDANIB
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| 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 | |||
| Dr Reddys | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 219283-001 | Apr 2, 2026 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Cipla | NINTEDANIB ESYLATE | nintedanib esylate | CAPSULE;ORAL | 212609-002 | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
