NINTEDANIB ESYLATE - Generic Drug Details

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-three patent family members in fifty-three countries.

There are eight drug master file entries for nintedanib esylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for NINTEDANIB ESYLATE

International Patents:	243
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Patent Applications:	148
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NINTEDANIB ESYLATE
DailyMed Link:	NINTEDANIB ESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NINTEDANIB ESYLATE

Dosage:

CAPSULE;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.

Generic filers with tentative approvals for NINTEDANIB ESYLATE

Applicant	Application No.	Strength	Dosage Form
		EQ 150MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for NINTEDANIB ESYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
OFEV	Capsules	nintedanib esylate	100 mg and 150 mg	205832	4	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			Y	Y
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014		RX	Yes	Yes
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014		RX	Yes	No					Y

Expired US Patents for NINTEDANIB ESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-002	Oct 15, 2014
Boehringer Ingelheim	OFEV	nintedanib esylate	CAPSULE;ORAL	205832-001	Oct 15, 2014

International Patents for NINTEDANIB ESYLATE

Country	Patent Number	Title	Estimated Expiration
Japan	2007302697	6-SUBSTITUTED INDOLINONE, METHOD FOR PRODUCING THE SAME AND ITS USE AS PHARMACEUTICAL COMPOSITION
Slovenia	2299987
Uruguay	27904	MONOETANOSULFONATO DE 3-Z-(1-(4-(N-((4-METIL-PIPERAZINA-1-IL)-METILCARBONIL)-N-METIL-AMINO)-ANILINO)-1-FENIL-METILEN)-6-METOXICARBONIL-2-INDOLINONA Y SU UTILIZACIÓN COMO MEDICAMENTO

Supplementary Protection Certificates for NINTEDANIB ESYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1830843	15C0046	France		PRODUCT NAME: NINTEDANIB,SES TAUTOMERES ET LEURS MELANGES AINSI QUE LES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE NINTEDANIB ET PLUS PARTICULIEREMENT L'ESILATE; REGISTRATION NO/DATE: EU/1/14/979 20150119
1224170	428	Finland