Nintedanib - Generic Drug Details
✉ Email this page to a colleague
Generic filers with tentative approvals for NINTEDANIB
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | EQ 150MG BASE | CAPSULE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | EQ 150MG BASE | CAPSULE;ORAL |
| ⤷ Start Trial | ⤷ Start Trial | EQ 100MG BASE | CAPSULE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | ||
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | AB | RX | Yes | 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 |
