Afatinib Oral Tablet

Brand(s)
Gilotrif
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Boehringer Ingelheim Pharmaceuticals, Inc. (2015-11-12)
Oldest Current Product
2013-07-12
License(s)
NDA
RxNORM
ORAL TABLET\AFATINIB
FDAOB
ORAL\TABLET\AFATINIB DIMALEATE
SPL Active
ORAL\TABLET, FILM COATED\AFATINIB
SPL Moiety
ORAL\TABLET, FILM COATED\AFATINIB

product(s) by strength(s)

afatinib 20 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970141GilotrifNDABoehringer Ingelheim Pharmaceuticals, Inc.2013-07-12AFATINIBORALTABLET, FILM COATEDNDA201292fd638e5e-8032-e7ca-0179-95e96ab5d387

afatinib 30 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970137GilotrifNDABoehringer Ingelheim Pharmaceuticals, Inc.2013-07-12AFATINIBORALTABLET, FILM COATEDNDA201292fd638e5e-8032-e7ca-0179-95e96ab5d387

afatinib 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1005970138GilotrifNDABoehringer Ingelheim Pharmaceuticals, Inc.2013-07-12AFATINIBORALTABLET, FILM COATEDNDA201292fd638e5e-8032-e7ca-0179-95e96ab5d387

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA201292GILOTRIFBOEHRINGER INGELHEIM2013-07-12pRE43431, SUBSTANCE
p8426586, SUBSTANCE
p8545884, SUBSTANCE
p6251912, TREATMENT OF CANCER, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2020-07-12]
NEW CHEMICAL ENTITY [2018-07-12]
NDA201292_001, NDA201292_002, NDA201292_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA201292_001RXAFATINIB DIMALEATE (EQ 20MG BASE)ORALTABLETFalse2013-07-12GILOTRIF
2NDA201292_002RXAFATINIB DIMALEATE (EQ 30MG BASE)ORALTABLETFalse2013-07-12GILOTRIF
3NDA201292_003RXAFATINIB DIMALEATE (EQ 40MG BASE)ORALTABLETTrue2013-07-12GILOTRIF

patent(s)

#idexpiration dateapplication(s)
1p6251912 (view patent)2018-07-29NDA201292
2p8426586 (view patent)2029-10-10NDA201292
3p8545884 (view patent)2029-12-19NDA201292
4pRE43431 (view patent)2022-01-22NDA201292

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1fd638e5e-8032-e7ca-0179-95e96ab5d387 (view SPL)These highlights do not include all the information needed to use GILOTRIF safely and effectively. See full prescribing information for GILOTRIF.GILOTRIF (afatinib) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionBoehringer Ingelheim Pharmaceuticals, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-127005970137, 005970138, 005970141

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII