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Nintedanib esylate - Generic Drug Details

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 seventy-two patent family members in forty-six countries.

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

Summary for nintedanib esylate

International Patents:	172
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	34
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

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Glossary

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

International Patents for nintedanib esylate

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Country	Document Number	Estimated Expiration
Uruguay	31876	➤ Sign Up
Argentina	040662	➤ Sign Up
Argentina	072059	➤ Sign Up
China	1391557	➤ Sign Up
South Africa	201007636	➤ Sign Up
Singapore	191607	➤ Sign Up
Australia	2015227503	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for nintedanib esylate

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015 00019	Denmark	➤ Sign Up	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
0725	Netherlands	➤ Sign Up	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
00725	Netherlands	➤ Sign Up	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
2015015,C1224170	Lithuania	➤ Sign Up	PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
8	Finland	➤ Sign Up
15/017	Ireland	➤ Sign Up	PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
C0024	France	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description