FDA Orange Book
Generic for Ofev
Ofev contains nintedanib esylate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Ofev is nintedanib esylate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Ofev products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 100MG BASE | Marketed (Rx) | AB | 9 | AB |
| capsule, oral | EQ 150MG BASE | Marketed (Rx) | AB | 9 | AB |
NDA 205832, held by BOEHRINGER INGELHEIM PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nintedanib esylate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 219227 | AB (A-rated, therapeutically equivalent) | April 2, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| CIPLA LTD | 212609 | AB (A-rated, therapeutically equivalent) | April 2, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| DEXCEL PHARMA TECHNOLOGIES LTD | 219819 | AB (A-rated, therapeutically equivalent) | April 2, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| DR REDDYS LABORATORIES LTD | 219283 | AB (A-rated, therapeutically equivalent) | April 2, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| SANDOZ INC | 216915 | AB (A-rated, therapeutically equivalent) | April 2, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| GLENMARK PHARMACEUTICALS LTD | 212555 | AB (A-rated, therapeutically equivalent) | July 9, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| HUMANWELL PURACAP PHARMACEUTICAL WUHAN CO LTD | 218472 | AB (A-rated, therapeutically equivalent) | July 9, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| MACLEODS PHARMACEUTICALS LTD | 219926 | AB (A-rated, therapeutically equivalent) | August 3, 2026 | EQ 100MG BASE, EQ 150MG BASE |
| BIOCON PHARMA LTD | 220118 | AB (A-rated, therapeutically equivalent) | August 19, 2026 | EQ 100MG BASE, EQ 150MG BASE |
Ofev patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 6762180 | October 1, 2025 | Drug substance, Drug product | None | 205832 |
| 10154990 | January 8, 2026 | Method of use | U-2620 | 205832 |
| 6762180*PED | April 1, 2026 | Method of use | None | 205832 |
| 10154990*PED | July 8, 2026 | Method of use | None | 205832 |
| 10105323 | June 4, 2029 | Drug product | None | 205832 |
| 9907756 | June 7, 2029 | Drug product | None | 205832 |
| 10105323*PED | December 4, 2029 | Method of use | None | 205832 |
| 9907756*PED | December 7, 2029 | Method of use | None | 205832 |
Ofev exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| ODE-261 | Orphan drug exclusivity | September 6, 2026 | 205832 |
| PED | Pediatric exclusivity | March 6, 2027 | 205832 |
Ofev NDC codes
Questions
Is there a generic for Ofev?
Yes. The generic name for Ofev is nintedanib esylate. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Ofev?
The active ingredient in Ofev is nintedanib esylate, per the FDA Orange Book.
When does the Ofev patent expire?
The last patent listed for Ofev in the Orange Book expires December 7, 2029. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.