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
Summary for OFEV
International Patents: | 241 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 198 |
Patent Applications: | 2,541 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for OFEV |
What excipients (inactive ingredients) are in OFEV? | OFEV excipients list |
DailyMed Link: | OFEV at DailyMed |


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 Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for OFEV
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
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 |