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Last Updated: December 1, 2020

DrugPatentWatch Database Preview

Nintedanib esylate - Generic Drug Details

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What are the generic 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 thirty-nine 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:239
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 Y   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 Y   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   Start Trial   Start Trial Y Y   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
1224170 17/2015 Austria   Start Trial PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843 C300747 Netherlands   Start Trial PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170 SPC/GB15/018 United Kingdom   Start Trial PRODUCT NAME: NINTEDANIB*, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE. *NINTEDANIB IS 3-Z-(1-(4-N-((4-METHYL-PIPERAZIN-1-YL)-METHYLCARBONYL)-N-METHYL-AMINO)-A; REGISTERED: UK EU/1/14/954/001 20141125; UK EU/1/14/954/002 20141125; UK EU/1/14/954/003 20141125; UK EU/1/14/954/004 20141125
1224170 1590015-2 Sweden   Start Trial PRODUCT NAME: NINTEDANIB, THE TAUTOMERS AND THE SALTS THEREOF, IN PARTICULAR NINTEDANIB AND PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF, SPECIFICALLY NINTEDANIB ESILATE; REG. NO/DATE: EU/1/14/954 20141121
1830843 1590034-3 Sweden   Start 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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Dow
Mallinckrodt
Merck
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.