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Last Updated: May 31, 2023

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 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 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 three 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
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: ⤷  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

SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE
Exclusivity Expiration: ⤷  Try a Trial

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

TREATMENT FOR CHRONIC FIBROSING INTERSTITIAL LUNG DISEASES WITH A PROGRESSIVE PHENOTYPE
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 ⤷  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
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes ⤷  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
>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: ⤷  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
Israel 208954 צורת מינון רוקחית שהינה קפסולה המכילה הרכב תרחיפי של נגזרת אינדולינון (Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative) ⤷  Try a Trial
Slovenia 1224170 ⤷  Try a Trial
Peru 20040704 MONOETANOSULFONATO DE 3-Z-[1-(4-(N-((4-METIL-PIPERAZINA-1-IL)-METILCARBONIL)-N-METIL-AMINO)-ANILINO)-1-FENIL-METILEN]-6-METOXICARBONIL-2-INDOLINONA Y PREPARACION DE MEDICAMENTOS QUE LOS COMPRENDEN ⤷  Try a Trial
Canada 2495350 UTILISATION D'INHIBITEUR LCK POUR LE TRAITEMENT D'AFFECTIONSIMMUNOLOGIQUES (USE OF LCK INHIBITOR FOR TREATMENT OF IMMUNOLOGIC DISEASES) ⤷  Try a Trial
South Africa 200202764 6-position substituted indoline, production and use thereof as a medicament. ⤷  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 254 5015-2015 Slovakia ⤷  Try a 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 CR 2015 00036 Denmark ⤷  Try a Trial PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150119
1224170 CR 2015 00019 Denmark ⤷  Try a Trial 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
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
1830843 00160 Estonia ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Colorcon
AstraZeneca
Harvard Business School
Boehringer Ingelheim

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.