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Generated: June 16, 2019

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Afatinib dimaleate - Generic Drug Details

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What are the generic sources for afatinib dimaleate and what is the scope of afatinib dimaleate patent protection?

Afatinib dimaleate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Afatinib dimaleate has one hundred and seventy-two patent family members in forty-four countries.

There are six drug master file entries for afatinib dimaleate. One supplier is listed for this compound.

Pharmacology for afatinib dimaleate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for afatinib dimaleate
(2E)-N-(4-((3-Chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydrofuran-3-yl)oxy)quinazolin- 6-yl)-4-(dimethylamino)but-2-enamide bis(hydrogen (2Z)-but-2-enedioate)
(2E)-N-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3S
(2E)-N-(4-[(3-chloro-4-fluorophenyl)amino]-7-{[(3S)-tetrahydrofuran-3-yl]oxy}quinazolin-6-yl)-4-(dimethylamino)but-2-enamide
(2E)-N-{4-[(3-chloro-4-fluorophenyl)amino]-7-[(3S)-tetrahydrofuran-3-yloxy]quinazolin-6-yl}-4-(dimethylamino)but-2-enamide di[(2Z)-but-2-enedioate]
(E)-4-Dimethylamino-But-2-Enoic Acid-(4-(3-Chloro-4-Fluoro-Phenylamino)-7-((S)-Tetra-Hydrofuran-3-Yloxy)-Quinazolin-6Yl)-Amide Dimaleate
(Z)-but-2-enedioic acid;(E)-N-[4-(3-chloro-4-fluoroanilino)-7-[(3S)-oxolan-3-yl]oxyquinazolin-6-yl]-4-(dimethylamino)but-2-enamide
2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-(((3S)-tetrahydro-3-furanyl)oxy)- 6-quinazolinyl)-4-(dimethylamino)-, (2E)-, (2Z)-2-butenedioate (1:2)
850140-73-7
AC-26080
ACN-043929
Afatinib (BIBW2992) Dimaleate
Afatinib (diMaleate)
Afatinib dimaleate (USAN)
Afatinib dimaleate [USAN]
Afatinib maleate
Afatinib maleate (JAN)
AK175999
AKOS025401819
AOB87350
BIBW 2992MA2
BIBW2992 MA2
CHEBI:76003
CHEMBL2105712
CS-1329
D09733
Gilotrif
Gilotrif (TN)
Giotrif
Giotrif (TN)
HY-10261A
KB-333876
MolPort-028-744-902
QC-11139
SC-87788
UNII-V1T5K7RZ0B
USNRYVNRPYXCSP-JUGPPOIOSA-N
V1T5K7RZ0B

US Patents and Regulatory Information for afatinib dimaleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for afatinib dimaleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for afatinib dimaleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910 PA2014005 Lithuania ➤ Try a Free Trial PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 1490011-2 Sweden ➤ Try a Free Trial PRODUCT NAME: AFATINIB, TAUTOMERER, STEREOISOMERER OCH SALTER DAERAV, FYSIOLOGISKT GODTAGBARA SALTER MED OORGANISKA ELLER ORGANISKA SYROR ELLER BASER, SAERSKILT ETT MALEATSALT DAERAV, MER FOERETRAEDELSEVIS ETT DIMALEATSALT DAERAV; REG. NO/DATE: EU/1/13/879 20130925
1345910 CA 2014 00006 Denmark ➤ Try a Free Trial PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925
1345910 2014C/009 Belgium ➤ Try a Free Trial PRODUCT NAME: AFATINIB ET SES TAUTOMERES, SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES, EN PARTICULIER, AFATINIB SOUS FORME DE SEL DE MALEATE OU DE DIMALEATE; AUTHORISATION NUMBER AND DATE: EU/1/13/879 20130927
1345910 C300643 Netherlands ➤ Try a Free Trial PRODUCT NAME: AFATINIB, DE TAUTOMEREN, STEREOISOMEREN EN ZOUTEN DAARVAN, IN HET BIJZONDER FYSIOLOGISCH AANVAARDBARE ZOUTEN MET ANORGANISCHE OF ORGANISCHE ZUREN OF BASEN, MEER IN HET BIJZONDER ZOUTEN MET MALEINEZUUR, MET NAME EEN DIMALEAATZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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