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Last Updated: May 24, 2024

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OFEV Drug Patent 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 forty-four patent family members in fifty-three 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.

DrugPatentWatch® 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 December 7, 2029. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (nintedanib esylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for OFEV
Drug Prices for OFEV

See drug prices for OFEV

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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 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 OFEV

OFEV is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OFEV is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting OFEV

Pharmaceutical dosage form for immediate release of an indolinone derivative
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Medicaments for the treatment or prevention of fibrotic diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Substituted indolines which inhibit receptor tyrosine kinases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an- ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulpho- nate and the use thereof as a pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

FDA Regulatory Exclusivity protecting OFEV

INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
Exclusivity Expiration: ⤷  Sign Up

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 205832-001 Oct 15, 2014 RX Yes No ⤷  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 ⤷  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 205832-002 Oct 15, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  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

Expired US Patents for OFEV

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OFEV

When does loss-of-exclusivity occur for OFEV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 2059
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 09254548
Estimated Expiration: ⤷  Sign Up

Patent: 15227503
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 0913434
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 26267
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 10001279
Estimated Expiration: ⤷  Sign Up

China

Patent: 2056598
Estimated Expiration: ⤷  Sign Up

Patent: 5193720
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 80467
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0180709
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20533
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 10010660
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 9996
Estimated Expiration: ⤷  Sign Up

Patent: 1001856
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 39187
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 8954
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 61031
Estimated Expiration: ⤷  Sign Up

Patent: 05542
Estimated Expiration: ⤷  Sign Up

Patent: 11522812
Estimated Expiration: ⤷  Sign Up

Patent: 14208712
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 8930
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 9229
Estimated Expiration: ⤷  Sign Up

Patent: 10013203
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 385
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 3162
Estimated Expiration: ⤷  Sign Up

Norway

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 100254
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 99987
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 142
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 99987
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1007636
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1725469
Estimated Expiration: ⤷  Sign Up

Patent: 110017872
Estimated Expiration: ⤷  Sign Up

Patent: 170020557
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 69469
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 1002691
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 10000558
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 4590
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 879
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OFEV around the world.

Country Patent Number Title Estimated Expiration
Ecuador SP10010717 FORMA DE DOSIFICACIÓN FARMACEUTICA PARA LA LIBERACIÓN INMEDIATA DE UN DERIVADO DE INDOLINA ⤷  Sign Up
China 100351235 ⤷  Sign Up
Canada 2726648 FORME POSOLOGIQUE PHARMACEUTIQUE POUR LIBERATION IMMEDIATE DE DERIVE D'INDOLINONE (PHARMACEUTICAL DOSAGE FORM FOR IMMEDIATE RELEASE OF AN INDOLINONE DERIVATIVE) ⤷  Sign Up
South Korea 101235094 ⤷  Sign Up
Saudi Arabia 1864 المركب indolinone-monoethanesulphonate methylene]-6-methoxycarbony1-2- N-methy1-amino) -anilino)-1-pheny1-methy1-amino)-anilino)-1pheny1-methy1-piperazin-1-y1)-methylcarbony1)-3-Z-[1-(4-(N))4- ⤷  Sign Up
Malaysia 127956 SUBSTITUTED INDOLINES WHICH INHIBIT RECEPTOR TYROSINE KINASES ⤷  Sign Up
China 1671660 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 composi ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 C01224170/01 Switzerland ⤷  Sign Up PRODUCT NAME: NINTEDANIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65330 13.08.2015
1224170 PA2015015 Lithuania ⤷  Sign Up PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1830843 2015C/038 Belgium ⤷  Sign Up PRODUCT NAME: NINTEDANIB, OU UN TAUTOMERE DE CELUI-CI, DES MELANGES DE CEUX-CI OU UN SEL DE CELUI-CI, SPECIFIQUEMENTNINTEDANIB SOUS FORME D'ESILATE; AUTHORISATION NUMBER AND DATE: EU/1/14/979/001 20150119
1830843 132016000021977 Italy ⤷  Sign Up 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 C300747 Netherlands ⤷  Sign Up PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115
1224170 CR 2015 00019 Denmark ⤷  Sign Up PRODUCT NAME: NINTEDANIB, TAUTOMERERNE OG SALTENE DERAF, SAERLIGT NINTEDANIB OG FYSIOLOGISK ACCEPTABLE SALTE DERAF, SPECIFIKT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/954/001-004 20141121
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
>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.