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 two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Entrectinib has one hundred and twenty-two patent family members in thirty countries.
One supplier is listed for this compound.
Summary for entrectinib
International Patents: | 122 |
US Patents: | 14 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 59 |
Clinical Trials: | 31 |
Patent Applications: | 986 |
What excipients (inactive ingredients) are in entrectinib? | entrectinib excipients list |
DailyMed Link: | entrectinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for entrectinib
Generic Entry Dates for entrectinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for entrectinib*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS OLDER THAN 1 MONTH UP TO 12 YEARS OF AGE WITH SOLID TUMORS THAT HAVE A NEUROTROPHIC TYROSINE RECEPTOR KINASE (NTRK) GENE FUSION, AS DETECTED BY AN FDA-APPROVED TEST WITHOUT A KNOWN ACQUIRED RESISTANCE MUTATION, ARE METASTATIC OR WHERE SURGICAL RESECTION IS LIKELY TO RESULT IN SEVERE MORBIDITY, AND HAVE PROGRESSED FOLLOWING TREATMENT OR HAVE NO SATISFACTORY ALTERNATIVE THERAPY Dosage:
PELLETS;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.
Recent Clinical Trials for entrectinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Birmingham | Phase 2/Phase 3 |
Cancer Research UK | Phase 2/Phase 3 |
Royal Marsden NHS Foundation Trust | Phase 2/Phase 3 |
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 |
---|---|---|---|
Mexico | 2018014298 | NUEVA FORMA CRISTALINA DE N-[5-(3,5-DIFLUORO-BENCILO)-1H-INDAZOL-3 -IL]-4-(4-METILO-PIPERAZINA-1-IL)-2-(TETRAHIDRO-PIRANO-4-ILAMINO) -BENZAMIDA. (NEW CRYSTALLINE FORM OF N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-Y L]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BE NZAMIDE.) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2015124697 | ⤷ Try a Trial | |
European Patent Office | 3464276 | NOUVELLE FORME CRISTALLINE DE N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-MÉTHYL-PIPÉRAZIN-1-YL)-2-(TÉTRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE (NEW CRYSTALLINE FORM OF N-[5-(3,5-DIFLUORO-BENZYL)-1H-INDAZOL-3-YL]-4-(4-METHYL-PIPERAZIN-1-YL)-2-(TETRAHYDRO-PYRAN-4-YLAMINO)-BENZAMIDE) | ⤷ Try a Trial |
China | 104395308 | 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 | ⤷ Try a Trial |
Taiwan | 201400479 | 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 | ⤷ Try a Trial |
Singapore | 11201605816T | COMPOUNDS FOR TREATING PATIENTS WITH ROS1 MUTANT CANCER CELLS | ⤷ Try a Trial |
China | 106167485 | 苯甲酰胺类,含有苯甲酰胺类的组合物以及苯甲酰胺类的制备方法 (Benzamide, compositions containing same, and preparation process thereof) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for entrectinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2176231 | 2020C/551 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB OF ISOMEREN, TAUTOMEREN OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
2176231 | LUC00191 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB OU LES ISOMERES, TAUTOMERES, OU SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1460 20200803 |
2176231 | 132020000000164 | Italy | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB O SUOI ISOMERI, TAUTOMERI O SALI FARMACEUTICAMENTE ACCETTABILI(ROZLYTREK); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1460, 20200803 |
2176231 | 301090 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB, DAN WEL TAUTOMEREN, OF FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/20/1460 20200803 |
2176231 | C02176231/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67280 05.11.2020 |
2176231 | 46/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803 |
2176231 | 122020000081 | Germany | ⤷ Try a Trial | PRODUCT NAME: ENTRECTINIB ODER ISOMERE, TAUTOMERE ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1460 20200731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |