Lapatinib
As of the edition of 20 October 2026, Lapatinib is a small molecule: marketed, first approved in 2007 (US); acts on EGFR; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Tykerb
- First approved
- 13 March 2007 (US)
- Approvals on record
- 6 in 5 regions
- Holder of the most recent approval
- Novartis; 4 holders in all
- Registered trials
- 256, 69 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Urinary and reproductive; Nervous system; Pregnancy and women's health
US protection
US protection ends in 2029.
The last listed US drug-substance patent ends in 2029. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Lapatinib.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| EGFR | Epidermal growth factor receptor | P00533 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 13 | 9 | 0 | 3 |
| Phase 1 | 67 | 50 | 1 | 15 |
| Phase 2 | 147 | 87 | 3 | 48 |
| Phase 3 | 28 | 19 | 0 | 3 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 256 |