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FDA Orange Book · active-ingredient family

Lapatinib ditosylate

Lapatinib ditosylate is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:TYKERB · NDA 022059

1

Brand (NDA)

2

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · tablet

ProductApplicantApplicationTEApproved
TYKERBRLDNOVARTISNDA 022059ABMar 13, 2007

Generic (ANDA) products (2)

ProductApplicantApplicationTEApproved
LAPATINIB DITOSYLATETEVA PHARMS USA INCANDA 217968ABAug 16, 2024
LAPATINIB DITOSYLATENATCO PHARMA LTDANDA 203007ABSep 29, 2020

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8821927Sep 18, 2029in 3 yr 4 mo
SubstanceProduct

Lapatinib ditosylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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