Afatinib dimaleate - Generic Drug Details

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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-seven 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:	187
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	9
Patent Applications:	1,394
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for afatinib dimaleate
DailyMed Link:	afatinib dimaleate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for afatinib dimaleate

Generic Entry Date for afatinib dimaleate^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

Anatomical Therapeutic Chemical (ATC) Classes for afatinib dimaleate

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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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	201292-002	Jul 12, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for afatinib dimaleate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for afatinib dimaleate

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Country	Patent Number	Title	Estimated Expiration
South Korea	101180752		⤷ Sign Up
Japan	2010202668	METHOD FOR PREPARING AMINO CROTONYL COMPOUND	⤷ Sign Up
Eurasian Patent Organization	201001852	ТВЕРДЫЕ ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ, СОДЕРЖАЩИЕ BIBW 2992	⤷ Sign Up
China	102056589	Solid pharmaceutical formulations comprising BIBW 2992	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for afatinib dimaleate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1345910	122014000016	Germany	⤷ Sign Up	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	SPC/GB14/015	United Kingdom	⤷ Sign Up	PRODUCT NAME: AFATINIB, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, IN PARTICULAR A SALT WITH MALEIC ACID; REGISTERED: UK EU/1/13/879/001 20130927; UK EU/1/13/879/002 20130927; UK EU/1/13/879/003 20130927; UK EU/1/13/879/004 20130927; UK EU/1/13/879/005 20130927; UK EU/1/13/879/006 20130927; UK EU/1/13/879/007 20130927; UK EU/1/13/879/008 20130927; UK EU/1/13/879/009 20130927; UK EU/1/13/879/010 20130927; UK EU/1/13/879/011 20130927; UK EU/1/13/879/012 20130927
1345910	C01345910/01	Switzerland	⤷ Sign Up	PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
1345910	1490011-2	Sweden	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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