FDA Orange Book
Generic for Tykerb
Tykerb contains lapatinib ditosylate. 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 Tykerb is lapatinib ditosylate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Tykerb and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Tykerb products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 250MG BASE | Marketed (Rx) | AB | 2 | AB |
NDA 022059, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lapatinib ditosylate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NATCO PHARMA LTD | 203007 | AB (A-rated, therapeutically equivalent) | September 29, 2020 | EQ 250MG BASE |
| TEVA PHARMACEUTICALS USA INC | 217968 | AB (A-rated, therapeutically equivalent) | August 16, 2024 | EQ 250MG BASE |
Tykerb patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8821927 | September 18, 2029 | Drug substance, Drug product | None | 022059 |
Tykerb NDC codes
Questions
Is there a generic for Tykerb?
Yes. The generic name for Tykerb is lapatinib ditosylate. 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 Tykerb?
The active ingredient in Tykerb is lapatinib ditosylate, per the FDA Orange Book.
When does the Tykerb patent expire?
The last patent listed for Tykerb in the Orange Book expires September 18, 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.