FDA Orange Book · active-ingredient family
Lapatinib ditosylate
Lapatinib ditosylate: 1 brand, 2 generics; first approved Mar 13, 2007; generic available.
Generic available
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
2
Listed patents
1
Next patent expiry
Sep 18, 2029
in 3 yr
Brand (NDA) products
Originator applications
- NOVARTISNDA 0220592007
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (2)
Abbreviated applications
- LAPATINIB DITOSYLATETEVA PHARMS USA INCANDA 2179682024
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB - LAPATINIB DITOSYLATENATCO PHARMA LTDANDA 2030072020
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8821927 | in 3 yr | SubstanceProduct |
Approval history
FDA approval span
First approval
19 yr 10 mo ago
Most recent approval
2 yr 2 mo ago
Approvals span 2007–2024 across 3 FDA applications.
Brand (NDA) 133%
Generic (ANDA) 267%
Lapatinib ditosylate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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