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Last Updated: March 19, 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-three 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 has been one patent litigation case 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Medicaments for the treatment or prevention of fibrotic diseases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Substituted indolines which inhibit receptor tyrosine kinases
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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: ⤷  Try a Trial

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 205832-002 Oct 15, 2014 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Australia

Patent: 09254548
Estimated Expiration: ⤷  Try a Trial

Patent: 15227503
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0913434
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 26267
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 10001279
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2056598
Estimated Expiration: ⤷  Try a Trial

Patent: 5193720
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 80467
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0180709
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20533
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 10010660
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 9996
Estimated Expiration: ⤷  Try a Trial

Patent: 1001856
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 39187
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8954
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 61031
Estimated Expiration: ⤷  Try a Trial

Patent: 05542
Estimated Expiration: ⤷  Try a Trial

Patent: 11522812
Estimated Expiration: ⤷  Try a Trial

Patent: 14208712
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8930
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 9229
Estimated Expiration: ⤷  Try a Trial

Patent: 10013203
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 385
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 3162
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 100254
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 142
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 99987
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1007636
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1725469
Estimated Expiration: ⤷  Try a Trial

Patent: 110017872
Estimated Expiration: ⤷  Try a Trial

Patent: 170020557
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 69469
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 1002691
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 10000558
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 4590
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 879
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 2878297 Médicaments pour le traitement ou la prévention des maladies fibrogènes (Medicaments for the treatment or prevention of fibrotic diseases) ⤷  Try a Trial
Poland 2878297 ⤷  Try a Trial
Israel 166405 3 - Z - [1 - 4 - (N - ((4 - METHYL - PIPERAZIN - 1 - YL) - METHYLCARBONYL) - N - METHYL - AMINO) ANILINO) - 1 -PHENYL- METHYLENE] - 6 - METHYXYCARBONYL - 2 - INDOLINONE - MONOETHANESULPHONATE AND THE USE THEREOF AS A PHARMACEUTICAL COMPOSITION ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1830843 132016000021977 Italy ⤷  Try a 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 300725 Netherlands ⤷  Try a 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
1224170 15C0024 France ⤷  Try a 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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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.