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Last Updated: January 20, 2021

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OFEV Drug Profile

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When do Ofev patents expire, and when can generic versions of Ofev launch?

Ofev is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and thirty-nine patent family members in fifty-one countries.

The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.

US ANDA Litigation and Generic Entry Outlook for Ofev

Ofev was eligible for patent challenges on October 15, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 7, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Drug patent expirations by year for OFEV
Drug Prices for OFEV

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Generic Entry Opportunity Date for OFEV
Generic Entry Date for OFEV*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Pharmacology for OFEV
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for OFEV
Tradename Dosage Ingredient NDA Submissiondate
OFEV CAPSULE;ORAL nintedanib esylate 205832 2018-10-15

US Patents and Regulatory Information for OFEV

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   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 205832-001 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 Y   Start Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   Start Trial   Start Trial Y 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 OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 300725 Netherlands   Start Trial 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 254 5015-2015 Slovakia   Start Trial PRODUCT NAME: NINTEDANIB VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150119
1830843 C20150026 00160 Estonia   Start Trial PRODUCT NAME: NINTEDANIIB;REG NO/DATE: EU/1/14/979 19.01.2015
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
1224170 428 Finland   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.