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Last Updated: March 1, 2021

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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 ClassKinase Inhibitor
Mechanism of ActionProtein 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   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for nintedanib esylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1830843 PA2015025 Lithuania   Start Trial PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1830843 132016000021977 Italy   Start Trial 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   Start Trial 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   Start Trial 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   Start Trial PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170 15C0024 France   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Harvard Business School
Merck
Colorcon
Moodys

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