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Generated: September 19, 2019

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Nintedanib esylate - Generic Drug Details

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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 ninety-eight patent family members in forty-nine countries.

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

Summary for nintedanib esylate
International Patents:198
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 9
Suppliers / Packagers: 1
Bulk Api Vendors: 51
Patent Applications: 44
DailyMed Link:nintedanib esylate at DailyMed
Pharmacology for nintedanib esylate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

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 ➤ 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 Y 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 205832-002 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 ➤ Sign Up
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up 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

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Supplementary Protection Certificates for nintedanib esylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 122015000023 Germany ➤ Sign Up PRODUCT NAME: NINTEDANIB, DESSEN TAUTOMERE UND DESSEN SALZE, INSBESONDERE NINTEDANIB UND PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170 C300725 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
1224170 SPC/GB15/018 United Kingdom ➤ Sign Up 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 17/2015 Austria ➤ Sign Up PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1224170 PA2015015,C1224170 Lithuania ➤ Sign Up PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170 300725 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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