You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 21, 2024

Nintedanib esylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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 forty-four 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
⤷  Sign Up⤷  Sign UpEQ 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 205832-002 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 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 205832-001 Oct 15, 2014 RX Yes No ⤷  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

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

International Patents for nintedanib esylate

Country Patent Number Title Estimated Expiration
South Korea 20110017872 CAPSULE PHARMACEUTICAL DOSAGE FORM COMPRISING A SUSPENSION FORMULATION OF AN INDOLINONE DERIVATIVE ⤷  Sign Up
Serbia 20050046 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) ⤷  Sign Up
Japan 2014098045 PHARMACEUTICAL DOSAGE FORM FOR IMMEDIATE RELEASE OF INDOLINONE DERIVATIVE ⤷  Sign Up
South Africa 200703601 Medicaments for the treatment or prevention of fibriotic diseases ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for nintedanib esylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1830843 41/2015 Austria ⤷  Sign Up PRODUCT NAME: NINTEDANIB, ODER EIN TAUTOMER, EINE MISCHUNG HIEVON ODER EIN SALZ HIEVON; INBESONDERE NINTEDANIB ESILATE.; REGISTRATION NO/DATE: EU/1/14/979 20150119
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
1830843 122015000052 Germany ⤷  Sign Up 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
1224170 428 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.