Entrectinib - Generic Drug Details
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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 fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Entrectinib has one hundred and seventeen patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for entrectinib
| International Patents: | 117 |
| US Patents: | 14 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 56 |
| Clinical Trials: | 29 |
| Patent Applications: | 1,127 |
| 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 |
|---|---|
| Taiho Oncology | Phase 1 |
| Oregon Health and Science University | Phase 2 |
| OHSU Knight Cancer Institute | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for entrectinib
US Patents and Regulatory Information for entrectinib
EU/EMA Drug Approvals for entrectinib
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Roche Registration GmbH | Rozlytrek | entrectinib | EMEA/H/C/004936 Rozlytrek as monotherapy is indicated for the treatment of adult and paediatric patients 12 years of age and older with solid tumours expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion,who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, andwho have not received a prior NTRK inhibitorwho have no satisfactory treatment options.Rozlytrek as monotherapy is indicated for the treatment of adult patients with ROS1 positive, advanced non small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. |
Authorised | no | no | no | 2020-07-31 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for entrectinib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Israel | 246544 | תרכובת לטיפול בחולים עם תאי סרטן מוטנט ros1 (Compounds for treating patients with ros1 mutant cancer cells) | See Plans and Pricing |
| South Korea | 20150058568 | 키나제 억제제로서 활성인 치환된 인다졸 유도체 (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS) | See Plans and Pricing |
| European Patent Office | 2855460 | PROCÉDÉ DE PRÉPARATION DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE (PROCESS FOR THE PREPARATION OF N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE) | See Plans and Pricing |
| Eurasian Patent Organization | 201691151 | СОЕДИНЕНИЯ ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ROS1-МУТАНТНЫМИ РАКОВЫМИ КЛЕТКАМИ | See Plans and Pricing |
| Taiwan | 200911233 | Substituted indazole derivatives active as kinase inhibitors | See Plans and Pricing |
| Ukraine | 118773 | СПОЛУКИ ДЛЯ ЛІКУВАННЯ ПАЦІЄНТІВ З ROS1-МУТАНТНИМИ РАКОВИМИ КЛІТИНАМИ (COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS) | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for entrectinib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2176231 | 2090052-8 | Sweden | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB OR TAUTOMERS, OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REG. NO/DATE: EU/1/20/1460 20200803 |
| 2176231 | CA 2020 00058 | Denmark | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB ELLER ISOMERER, TAUTOMERER ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/20/1460 20200803 |
| 2176231 | 122020000081 | Germany | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731 |
| 3107541 | 132021000000107 | Italy | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB IN TUTTE LE SUE FORME PROTETTE DAL BREVETTO DI BASE: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803 |
| 2176231 | LUC00191 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
| 2176231 | 2020C/551 | Belgium | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
