DrugPatentWatch Database Preview
OFEV Drug Profile
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.
Summary for OFEV
| International Patents: | 198 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 164 |
| Patent Applications: | 88 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for OFEV |
| DailyMed Link: | OFEV at DailyMed |
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 |
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 |
International Patents for OFEV
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 10237423 | See Pricing |
| Malaysia | 136883 | See Pricing |
| European Patent Office | 2299987 | See Pricing |
| Denmark | 2313087 | See Pricing |
| Norway | 322746 | See Pricing |
| Australia | 1023301 | See Pricing |
| Tunisia | 2010000555 | See Pricing |
| >Country | >Patent Number | >Estimated Expiration |
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 |
