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Nintedanib esylate - Generic Drug Details

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What are the generic sources for nintedanib esylate and what is the scope of nintedanib esylate patent protection?

Nintedanib esylate 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.

Nintedanib esylate has one hundred and ninety-eight patent family members in forty-nine countries.

There are nine drug master file entries for nintedanib esylate. One supplier is listed for this compound.

Summary for nintedanib esylate

International Patents:	198
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	51
Patent Applications:	44
DailyMed Link:	nintedanib esylate at DailyMed

Pharmacology for nintedanib esylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

US Patents and Regulatory Information for nintedanib esylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes			Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No			Y	Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes			Y	Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes			Y

International Patents for nintedanib esylate

Country	Patent Number	Estimated Expiration
Slovenia	2299987
European Patent Office	1530466
World Intellectual Property Organization (WIPO)	2009147220
Ecuador	SP10010660
Malaysia	158930
Argentina	094217

Supplementary Protection Certificates for nintedanib esylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1224170	122015000023	Germany		PRODUCT NAME: NINTEDANIB, DESSEN TAUTOMERE UND DESSEN SALZE, INSBESONDERE NINTEDANIB UND PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	C300725	Netherlands		PRODUCT NAME: NINTEDANIB, DE TAUTOMEREN DAARVAN EN DE ZOUTEN DAARVAN, IN HET BIJZONDER NINTEDANIB EN FYSIOLOGISCH AANVAARDBARE ZOUTEN DAARVAN, MET NAME NINEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	SPC/GB15/018	United Kingdom		PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
1224170	17/2015	Austria		PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1224170	PA2015015,C1224170	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170	300725	Netherlands		PRODUCT NAME: NINTEDANIB, DE TAUTOMEREN DAARVAN EN DE ZOUTEN DAARVAN, IN HET BIJZONDER NINTEDANIB EN FYSIOLOGISCH AANVAARDBARE ZOUTEN DAARVAN, MET NAME NINEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141125