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Last Updated: May 20, 2022

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-one 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.

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 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.

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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Summary for OFEV
Drug patent expirations by year for OFEV
Drug Prices for OFEV

See drug prices for OFEV

DrugPatentWatch® Estimated 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 Action Protein 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 three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of OFEV is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Medicaments for the treatment or prevention of fibrotic diseases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF NINTEDANIB FOR SLOWING THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)

Substituted indolines which inhibit receptor tyrosine kinases
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting OFEV

SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE
Exclusivity Expiration: See Plans and Pricing

INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD)
Exclusivity Expiration: See Plans and Pricing

TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

Australia

Patent: 09254548
Estimated Expiration: See Plans and Pricing

Patent: 15227503
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0913434
Estimated Expiration: See Plans and Pricing

Canada

Patent: 26267
Estimated Expiration: See Plans and Pricing

Chile

Patent: 10001279
Estimated Expiration: See Plans and Pricing

China

Patent: 2056598
Estimated Expiration: See Plans and Pricing

Patent: 5193720
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 80467
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0180709
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20533
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 99987
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 10010660
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 9996
Estimated Expiration: See Plans and Pricing

Patent: 1001856
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 99987
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 39187
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8954
Estimated Expiration: See Plans and Pricing

Japan

Patent: 61031
Estimated Expiration: See Plans and Pricing

Patent: 05542
Estimated Expiration: See Plans and Pricing

Patent: 11522812
Estimated Expiration: See Plans and Pricing

Patent: 14208712
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 99987
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 8930
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 9229
Estimated Expiration: See Plans and Pricing

Patent: 10013203
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 385
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 3162
Estimated Expiration: See Plans and Pricing

Norway

Patent: 99987
Estimated Expiration: See Plans and Pricing

Peru

Patent: 100254
Estimated Expiration: See Plans and Pricing

Poland

Patent: 99987
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 99987
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 142
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 99987
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1007636
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1725469
Estimated Expiration: See Plans and Pricing

Patent: 110017872
Estimated Expiration: See Plans and Pricing

Patent: 170020557
Estimated Expiration: See Plans and Pricing

Spain

Patent: 69469
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1002691
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 10000558
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4590
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 879
Estimated Expiration: See Plans and Pricing

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
China 102056599 Pharmaceutical dosage form for immediate release of an indolinone derivative See Plans and Pricing
Taiwan 201002691 Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative See Plans and Pricing
Denmark 1527047 See Plans and Pricing
Slovenia 2313087 See Plans and Pricing
Japan 5039279 See Plans and Pricing
Bulgaria 106587 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 2015/017 Ireland See Plans and Pricing PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170 SPC/GB15/018 United Kingdom See Plans and Pricing 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
1830843 C20150026 00160 Estonia See Plans and Pricing PRODUCT NAME: NINTEDANIIB;REG NO/DATE: EU/1/14/979 19.01.2015
1224170 PA2015015,C1224170 Lithuania See Plans and Pricing PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
1224170 300725 Netherlands See Plans and Pricing 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 92762 Luxembourg See Plans and Pricing PRODUCT NAME: NINTEDANIB , OU UN TAUTOMERE, LES MELANGES OBTENUS OU UN DESES SELS, EN PARTICULIER NINTEDANIB ESILATE. FIRST REGISTRATION: 20150119
>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.