FDA Orange Book
Is there a generic for Nerlynx?
Nerlynx contains neratinib. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nerlynx (neratinib). The Orange Book shows its last listed patent expires July 18, 2031.
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Nerlynx products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 40MG BASE | Marketed (Rx) | None | 0 | None |
NDA 208051, held by PUMA BIOTECHNOLOGY INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nerlynx patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10035788 | October 15, 2028 | Method of use | U-2043 | 208051 |
| 9630946 | October 15, 2028 | Method of use | U-2043 | 208051 |
| 9139558 | October 15, 2028 | Method of use | U-3097 | 208051 |
| 9139558 | October 15, 2028 | Method of use | U-3047 | 208051 |
| 9630946 | October 15, 2028 | Method of use | U-3047 | 208051 |
| 9630946 | October 15, 2028 | Method of use | U-3097 | 208051 |
| 10035788 | October 15, 2028 | Method of use | U-3047 | 208051 |
| 10035788 | October 15, 2028 | Method of use | U-3097 | 208051 |
| 9139558 | October 15, 2028 | Method of use | U-2043 | 208051 |
| 9265784 | August 4, 2029 | Method of use | U-3047 | 208051 |
| 9211291 | March 24, 2030 | Method of use | U-2043 | 208051 |
| 9211291 | March 24, 2030 | Method of use | U-3097 | 208051 |
| 8790708 | November 5, 2030 | Drug product | U-2043 | 208051 |
| 8790708 | November 5, 2030 | Drug product | U-3097 | 208051 |
| 8790708 | November 5, 2030 | Drug product | U-3047 | 208051 |
| 8518446 | November 20, 2030 | Drug product | U-2043 | 208051 |
| 8518446 | November 20, 2030 | Drug product | U-3097 | 208051 |
| 8518446 | November 20, 2030 | Drug product | U-3047 | 208051 |
| 7399865 | December 29, 2030 | Drug substance, Drug product | None | 208051 |
| 8669273 | July 18, 2031 | Method of use | U-3047 | 208051 |
Nerlynx NDC codes
Questions
Is there a generic for Nerlynx?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nerlynx (neratinib). The Orange Book shows its last listed patent expires July 18, 2031.
What is the generic name for Nerlynx?
The active ingredient in Nerlynx is neratinib, per the FDA Orange Book.
When does the Nerlynx patent expire?
The last patent listed for Nerlynx in the Orange Book expires July 18, 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.