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Last Updated: March 28, 2024

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-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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NINTEDANIB ESYLATE
Generic Entry Date for NINTEDANIB ESYLATE*:
Constraining patent/regulatory exclusivity:
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
⤷  Try a Trial⤷  Try a TrialEQ 150MG BASECAPSULE;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 ClassKinase Inhibitor
Mechanism of ActionProtein 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

International Patents for NINTEDANIB ESYLATE

Country Patent Number Title Estimated Expiration
Portugal 1830843 ⤷  Try a Trial
Taiwan I285635 ⤷  Try a Trial
Peru 20100050 FORMA DE DOSIFICACION FARMACEUTICA PARA LA LIBERACION INMEDIATA DE UN DERIVADO DE INDOLINONA ⤷  Try a Trial
Spain 2384968 ⤷  Try a Trial
Malaysia 148108 MEDICAMENTS FOR THE TREATMENT OR PREVENTION OF FIBROTIC DISEASES ⤷  Try a Trial
Serbia 52283 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) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NINTEDANIB ESYLATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1830843 C 2015 026 Romania ⤷  Try a Trial PRODUCT NAME: NINTEDANIB SAU UN TAUTOMER SAU AMESTECURI ALE ACESTORA SAU O SARE A ACESTORA, IN SPECIAL ESILAT DE NINTEDANIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/979/001-004; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/979/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20150115
1830843 15C0046 France ⤷  Try a Trial 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
1830843 132016000021977 Italy ⤷  Try a 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 300747 Netherlands ⤷  Try a Trial PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER, DE MENGSELS DAARVAN OF EEN ZOUT DAARVAN; IN HET BIJZONDER NINTEDANIBESILAAT; REGISTRATION NO/DATE: EU/1/14/979 20150115
1830843 1590034-3 Sweden ⤷  Try a Trial PRODUCT NAME: NINTEDANIB, OR A TAUTOMER, THE MIXTURES THEREOF ORA SALT THEROF; IN PARTICULAR NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/979 20150119
1224170 PA2015015,C1224170 Lithuania ⤷  Try a Trial PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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