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Nintedanib esylate - Generic Drug Details
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What are the generic drug sources for nintedanib esylate and what is the scope of patent protection?
Nintedanib esylate
is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Nintedanib esylate has two hundred and forty patent family members in fifty-one countries.
There are nine drug master file entries for nintedanib esylate. One supplier is listed for this compound.
Summary for nintedanib esylate
International Patents: | 240 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 9 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 58 |
Patent Applications: | 46 |
DailyMed Link: | nintedanib esylate at DailyMed |
Pharmacology for nintedanib esylate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Paragraph IV (Patent) Challenges for NINTEDANIB ESYLATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
OFEV | CAPSULE;ORAL | nintedanib esylate | 205832 | 2018-10-15 |
US Patents and Regulatory Information for nintedanib esylate
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 | 205832-002 | Oct 15, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 nintedanib esylate
Country | Patent Number | Estimated Expiration |
---|---|---|
Ukraine | 94390 | Start Trial |
Israel | 209055 | Start Trial |
Croatia | P20020306 | Start Trial |
Portugal | 1527047 | Start Trial |
China | 102056598 | Start Trial |
Peru | 20100050 | Start Trial |
European Patent Office | 1527047 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for nintedanib esylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1830843 | PA2015025 | Lithuania | Start Trial | PRODUCT NAME: NINTEDANIBUM; REGISTRATION NO/DATE: EU/1/14/979/001 - EU/1/14/979/004 20150115 |
1830843 | 132016000021977 | Italy | Start Trial | PRODUCT NAME: NINTEDANIB, SUOI TAUTOMERI, O LORO MISCELE O I SUOI SALI, IN PARTICOLARE ESILATO DI NINTEDANIB(OFEV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/979, 20150119 |
1830843 | CA 2015 00036 | Denmark | Start 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 20150115 |
1830843 | 122015000052 | Germany | Start Trial | 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 | C300747 | Netherlands | Start Trial | PRODUCT NAME: NINTEDANIB, OF EEN TAUTOMEER,; REGISTRATION NO/DATE: EU/1/14/979 20150115 |
1224170 | 15C0024 | France | Start Trial | 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 | 2015C/038 | Belgium | Start Trial | PRODUCT NAME: NINTEDANIB, OU UN TAUTOMERE DE CELUI-CI, DES MELANGES DE CEUX-CI OU UN SEL DE CELUI-CI, SPECIFIQUEMENTNINTEDANIB SOUS FORME D'ESILATE; AUTHORISATION NUMBER AND DATE: EU/1/14/979/001 20150119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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