Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKesson
McKinsey
Boehringer Ingelheim
Mallinckrodt
Johnson and Johnson
Colorcon

Last Updated: October 14, 2019

DrugPatentWatch Database Preview

OFEV Drug Profile

See Plans and Pricing

« Back to Dashboard

Which patents cover Ofev, 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 one hundred and ninety-eight patent family members in forty-nine 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.

Drug patent expirations by year for OFEV
Drug Prices for OFEV

See drug prices for OFEV

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 ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for OFEV

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 Pricing   See Pricing   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   See Pricing   See Pricing Y   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   See Pricing   See Pricing Y Y   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-002 Oct 15, 2014 RX Yes Yes   See Pricing   See Pricing   See Pricing
Boehringer Ingelheim OFEV nintedanib esylate CAPSULE;ORAL 205832-001 Oct 15, 2014 RX Yes No   See Pricing   See Pricing Y Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for OFEV
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 100 mg and 150 mg ➤ Subscribe   See Pricing

Supplementary Protection Certificates for OFEV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1224170 15C0024 France   See Pricing 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
1830843 CA 2015 00036 Denmark   See Pricing PRODUCT NAME: NINTEDANIB ELLER EN TAUTOMER, BLANDINGERNE DERAF ELLER ET SALT DERAF, SAERLIGT NINTEDANIB ESILAT; REG. NO/DATE: EU/1/14/979/001-004 20150115
1224170 SPC/GB15/018 United Kingdom   See 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
1224170 17/2015 Austria   See Pricing PRODUCT NAME: NINTEDANIB UND DESSEN PHYSIOLOGISCH VERTRAEGLICHE SALZE, INSBESONDERE NINTEDANIB ESILAT; REGISTRATION NO/DATE: EU/1/14/954 (MITTEILUNG) 20141125
1830843 122015000052 Germany   See Pricing 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
1830843 PA2015025,C1830843 Lithuania   See Pricing PRODUCT NAME: NINTEDANIBAS ARBA JO TAUTOMERAS, ARBA JU MISINIAI, ARBA JO DRUSKA; KONKRECIAI NINTEDANIBO ESILATAS; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115
1224170 2015/017 Ireland   See Pricing PRODUCT NAME: VARGATEF-NINTEDANIB, THE TAUTOMERS AND THE PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF; REGISTRATION NO/DATE: EU/1/14/954/001-004 20141121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Mallinckrodt
Merck
Colorcon
Medtronic

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 verifification 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.