FDA Orange Book
Generic for Gilotrif
Gilotrif contains afatinib. 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 Gilotrif is afatinib. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Gilotrif products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 20MG BASE | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | EQ 30MG BASE | Marketed (Rx) | AB | 2 | AB |
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 201292, held by BOEHRINGER INGELHEIM. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic afatinib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 210725 | AB (A-rated, therapeutically equivalent) | July 14, 2026 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE |
| HETERO LABS LTD UNIT V | 210750 | AB (A-rated, therapeutically equivalent) | July 14, 2026 | EQ 20MG BASE, EQ 30MG BASE, EQ 40MG BASE |
Gilotrif patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| RE43431 | January 13, 2026 | Drug substance | None | 201292 |
| RE43431*PED | July 13, 2026 | Method of use | None | 201292 |
| 9539258 | November 9, 2026 | Method of use | U-1950 | 201292 |
| 9539258*PED | May 9, 2027 | Method of use | None | 201292 |
| 8426586 | October 10, 2029 | Drug substance | None | 201292 |
| 8545884 | December 19, 2029 | Drug product | None | 201292 |
| 8426586*PED | April 10, 2030 | Method of use | None | 201292 |
| 8545884*PED | June 19, 2030 | Method of use | None | 201292 |
| 10004743 | July 5, 2030 | Drug product | None | 201292 |
| 10004743*PED | January 5, 2031 | Method of use | None | 201292 |
Gilotrif NDC codes
Questions
Is there a generic for Gilotrif?
Yes. The generic name for Gilotrif is afatinib. 2 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 Gilotrif?
The active ingredient in Gilotrif is afatinib, per the FDA Orange Book.
When does the Gilotrif patent expire?
The last patent listed for Gilotrif in the Orange Book expires January 5, 2031. 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.