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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 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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for nintedanib esylate

US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	8
Suppliers / Packagers:	1
Bulk Api Vendors:	30
Patent Applications:	39
DailyMed Link:	nintedanib esylate at DailyMed

Pharmacology for nintedanib esylate

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Synonyms for nintedanib esylate

(3Z)-2,3-Dihydro-3-[[[4-[methyl[2-(4-methyl-1-piperazinyl)acetyl]amino]phenyl]amino]phenylmethylene]-2-oxo-1H-indole-6-carboxylic acid methyl ester ethanesulfonate

(Z)-methyl 3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino)(phenyl)methylene)-2-oxoindoline-6-carboxylate ethanesulfonate

1H-Indole-6-carboxylic acid, 2,3-dihydro-3-(((4-(methyl(2-(4-methyl-1-piperazinyl)acetyl)amino)phenyl)amino)phenylmethylene)-2-oxo-, methyl ester, (3Z)-, ethanesulfonate (1:1)

42F62RTZ4G

656247-18-6

AC-28120

ACN-050740

AK323741

AKOS025402006

BIBF 1120 (esylate)

BIBF 1120 esylate

CHEBI:85170

CHEMBL3039504

CS-3475

DTXSID40215873

ethanesulfonic acid;methyl (3Z)-3-[[4-[methyl-[2-(4-methylpiperazin-1-yl)acetyl]amino]anilino]-phenylmethylidene]-2-oxo-1H-indole-6-carboxylate

HY-11106

KB-62821

KS-1447

Methyl (3Z)-3-(((4-(N-methyl-2-(4-methylpiperazin-1-yl)acetamido)phenyl)amino) (phenyl)methylidene)-2-oxo-2,3-dihydro-1H-indole-6-carboxylate ethanesulfonate

methyl (3Z)-3-[(4-{methyl[(4-methylpiperazin-1-yl)acetyl]amino}anilino)(phenyl)methylidene]-2-oxo-2,3-dihydro-1H-indole-6-carboxylate ethanesulfonate

MFCD26142360

MolPort-042-652-646

Nintedanib Esilate

Nintedanib ethanesulfonate

Nintedanib Ethanesulfonate Salt

NSC-753000

NSC753000

SC-90632

SCHEMBL2278759

SCHEMBL753253

UNII-42F62RTZ4G

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	205832-001	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	205832-001	Oct 15, 2014		RX	Yes	No

International Patents for nintedanib esylate

Country	Document Number	Estimated Expiration
Montenegro	P53708
Saudi Arabia	1621
Ecuador	SP055571
Colombia	5261488

Supplementary Protection Certificates for nintedanib esylate

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00019	Denmark		PRODUCT NAME: NINTEDANIB, TAUTOMERERNE OG SALTENE DERAF, SAERLIGT NINTEDANIB OG FYSIOLOGISK ACCEPTABLE SALTE DERAF, SPECIFIKT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/954/001-004 20141121
00725	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
15/017	Ireland		PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
2015015,C1224170	Lithuania		PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121