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-one patent family members in fifty-one 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:	241
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	68
Patent Applications:	165
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for nintedanib esylate
DailyMed Link:	nintedanib esylate at DailyMed

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

International Patents for nintedanib esylate

Country	Patent Number	Title	Estimated Expiration
Montenegro	00353	3-Z-[1-(4-(N-((4-METIL-PIPERAZIN-1-IL)-METILKARBONIL)-N-METIL-AMINO)-ANILINO)-1-FENIL-METILEN]-6-METOKSIKARBONIL-2-INDOLINON-MONOETANSULFONAT I NJEGOVA PRIMENA U FARMACEUTSKOJ KOMPOZICIJI (3-Z-[1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-ANILINO)-1-PHENYL-METHYLENE]-6-METHOXYCARBONYL-2-INDOLINONE-MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION)
Malaysia	127956	SUBSTITUTED INDOLINES WHICH INHIBIT RECEPTOR TYROSINE KINASES
Serbia	20050046	3-Z-(1-(4-(N-((4-METIL-PIPERAZIN-1-IL)- METILKARBONIL)-N- METIL-AMINO)- ANILINO)-1-FENIL-METILEN-6- METOKSIKARBONIL-2- INDOLINON- MONOETANSULFONAT I NjEGOVA PRIMENA U FARMACEUTSKOJ KOMPOZICIJI (3-Z-/1-(4-(N-((4-METHYL-PIPERAZIN-1-YL)- METHYLCARBONYL)-N- METHYL-AMINO)- ANILINO)-1-PHENYL-METHYLENE/-6- METHOXYCARBONYL -2-INDOLINONE- MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION)
European Patent Office	2878297	Médicaments pour le traitement ou la prévention des maladies fibrogènes (Medicaments for the treatment or prevention of fibrotic diseases)
Egypt	24562	3-Z-[1-(4-(n-((4-methyl-piperazin-1-yl)-methylcarbonyl)-n-methyl-amino)anilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulphonate and the use thereof as a pharmaceutical composition
Norway	330486
Peru	20100050	FORMA DE DOSIFICACION FARMACEUTICA PARA LA LIBERACION INMEDIATA DE UN DERIVADO DE INDOLINONA

Supplementary Protection Certificates for nintedanib esylate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1224170	PA2015015	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
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	C300747	Netherlands		PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170	C01224170/01	Switzerland		PRODUCT NAME: NINTEDANIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65330 13.08.2015
1830843	92762	Luxembourg		PRODUCT NAME: NINTEDANIB , OU UN TAUTOMERE, LES MELANGES OBTENUS OU UN DESES SELS, EN PARTICULIER NINTEDANIB ESILATE. FIRST REGISTRATION: 20150119
1224170	92681	Luxembourg		PRODUCT NAME: INDOLINONES SUBSTITUEES EN POSITION 6, LEUR PREPARATION ET LEUR UTILISATION EN TANT QUE MEDICAMENTS; FIRST REGISTRATION: 20141121