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 |
OHSU Knight Cancer Institute | Phase 2 |
Oregon Health and Science University | 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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 |
---|---|---|---|
China | 110913842 | 包括恩曲替尼的药物组合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING ENTRECTINIB) | See Plans and Pricing |
Russian Federation | 2014151565 | СПОСОБ ПОЛУЧЕНИЯ N-[5-(3,5-ДИФТОРБЕНЗИЛ)-1Н-ИНДАЗОЛ-3-ИЛ]-4-(4-МЕТИЛПИПЕРАЗИН-1-ИЛ)-2-(ТЕТРАГИДРОПИРАН-4-ИЛАМИНО)БЕНЗАМИДА | See Plans and Pricing |
Canada | 3069339 | COMPOSITIONS PHARMACEUTIQUES CONTENANT DE L'ENTRECTINIB (PHARMACEUTICAL COMPOSITIONS COMPRISING ENTRECTINIB) | See Plans and Pricing |
Taiwan | 201907924 | Pharmaceutical compositions and dosage forms | 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 | C02176231/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020 |
2176231 | 301090 | Netherlands | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803 |
3107541 | 21/2021 | Austria | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803 |
2176231 | C202030070 | Spain | See Plans and Pricing | PRODUCT NAME: ENTRECTINIB O SUS ISOMEROS, TAUTOMEROS, O SALES FARMACEUTICAMENTE ACEPTABLES.; NATIONAL AUTHORISATION NUMBER: EU/1/20/1460; DATE OF AUTHORISATION: 20200731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1460; DATE OF FIRST AUTHORISATION IN EEA: 20200731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |