Afatinib dimaleate - Generic Drug Details

What are the generic sources for afatinib dimaleate and what is the scope of freedom to operate?

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 eighty-six patent family members in forty-six countries.

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

Summary for afatinib dimaleate

International Patents:	186
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	9
Patent Applications:	1,972
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for afatinib dimaleate
DailyMed Link:	afatinib dimaleate at DailyMed

Recent Clinical Trials for afatinib dimaleate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Chest Hospital	Phase 4
University of Washington	Phase 1
University of California, Davis	Phase 1

See all afatinib dimaleate clinical trials

Pharmacology for afatinib dimaleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for AFATINIB DIMALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GILOTRIF	Tablets	afatinib dimaleate	20 mg, 30 mg and 40 mg	201292	7	2017-07-12

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	201292-001	Jul 12, 2013		RX	Yes	No
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No					Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No

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
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013

International Patents for afatinib dimaleate

Country	Patent Number	Title	Estimated Expiration
Croatia	P20161061
Norway	325672
South Korea	20060120121	METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS
World Intellectual Property Organization (WIPO)	2009147238
Australia	2009254574	Solid pharmaceutical formulations comprising BIBW 2992
South Korea	100852102

Supplementary Protection Certificates for afatinib dimaleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	14C0009	France		PRODUCT NAME: AFATINIB,SES TAUTOMERES,SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES,EN PARTICULIER LE MALEATE OU LE DIMALEATE.; REGISTRATION NO/DATE: EU/1/13/879 20130925
1345910	C300643	Netherlands		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
1345910	CR 2014 00006	Denmark		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	1490011-2	Sweden		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	122014000016	Germany		PRODUCT NAME: AFATINIB, DIE TAUTOMEREN, DIE STEREOISOMEREN UND DIE SALZE DAVON, INSBESONDERE PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, INSBESONDERE SALZE MIT MALEINSAEURE; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
1345910	C01345910/01	Switzerland		PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014