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Entrectinib - Generic Drug Details
What are the generic sources for entrectinib and what is the scope of patent protection?
Entrectinib
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Entrectinib has one hundred and eleven patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for entrectinib
| International Patents: | 111 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 44 |
| Clinical Trials: | 19 |
| Patent Applications: | 644 |
| What excipients (inactive ingredients) are in entrectinib? | entrectinib excipients list |
| DailyMed Link: | entrectinib at DailyMed |
Recent Clinical Trials for entrectinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 3 |
| Helse Fonna HF | Phase 2 |
| St. Olavs Hospital | Phase 2 |
US Patents and Regulatory Information for entrectinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-001 | Aug 15, 2019 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 entrectinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2013174876 | ⤷ Try it Free |
| Japan | 2020527575 | ⤷ Try it Free |
| South Korea | 20100044859 | ⤷ Try it Free |
| Taiwan | 201907924 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for entrectinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2176231 | LUC00191 | Luxembourg | ⤷ Try it Free | PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
| 2176231 | 46/2020 | Austria | ⤷ Try it Free | PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803 |
| 2176231 | C02176231/01 | Switzerland | ⤷ Try it Free | PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020 |
| 3107541 | 2021C/522 | Belgium | ⤷ Try it Free | PRODUCT NAME: ENTRECTINIB IN ALLE VORMEN ZOALS BESCHERMD DOOR HET BASISOCTROOI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
