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Nintedanib esylate - Generic Drug Details

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What are the generic drug sources for nintedanib esylate and what is the scope of 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 two hundred and forty patent family members in fifty-one countries.

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

Summary for nintedanib esylate

International Patents:	240
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	58
Patent Applications:	46
DailyMed Link:	nintedanib esylate at DailyMed

Pharmacology for nintedanib esylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE

Tradename	Dosage	Ingredient	NDA	Submissiondate
OFEV	CAPSULE;ORAL	nintedanib esylate	205832	2018-10-15

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
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
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No			Y

International Patents for nintedanib esylate

Country	Patent Number	Estimated Expiration
Ukraine	94390
Israel	209055
Croatia	P20020306
Portugal	1527047
China	102056598
Peru	20100050
European Patent Office	1527047

Supplementary Protection Certificates for nintedanib esylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1830843	PA2015025	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1830843	132016000021977	Italy		PRODUCT NAME: NINTEDANIB, SUOI TAUTOMERI, O LORO MISCELE O I SUOI SALI, IN PARTICOLARE ESILATO DI NINTEDANIB(OFEV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/979, 20150119
1830843	CA 2015 00036	Denmark		PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150115
1830843	122015000052	Germany		PRODUCT NAME: NINTEDANIB ODER EIN TAUTOMER, DIE MISCHUNGEN HIERVON, ODER EIN SALZ HIERVON, INSBESONDERE NINTEDANIB-ESILAT; REGISTRATION NO/DATE: EU/1/14/979/001-004 20150115
1830843	C300747	Netherlands		PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170	15C0024	France		PRODUCT NAME: NINTEDANIB,SES TAUTOMERES ET SES SELS,EN PARTICULIER LES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE NINTEDANIB ET PLUS PARTICULIEREMENT L'ESILATE; REGISTRATION NO/DATE: EU/1/14/954 20141125
1830843	2015C/038	Belgium		PRODUCT NAME: NINTEDANIB, OU UN TAUTOMERE DE CELUI-CI, DES MELANGES DE CEUX-CI OU UN SEL DE CELUI-CI, SPECIFIQUEMENTNINTEDANIB SOUS FORME D'ESILATE; AUTHORISATION NUMBER AND DATE: EU/1/14/979/001 20150119