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Last Updated: March 3, 2024

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

SponsorPhase
University of BirminghamPhase 2/Phase 3
Cancer Research UKPhase 2/Phase 3
Royal Marsden NHS Foundation TrustPhase 2/Phase 3

See all entrectinib clinical trials

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 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-002 Aug 15, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genentech Inc ROZLYTREK entrectinib CAPSULE;ORAL 212725-001 Aug 15, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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
Eurasian Patent Organization 201070167 ЗАМЕЩЕННЫЕ ПРОИЗВОДНЫЕ ИНДАЗОЛА, АКТИВНЫЕ КАК ИНГИБИТОРЫ КИНАЗЫ ⤷  Try a Trial
South Korea 20150058568 키나제 억제제로서 활성인 치환된 인다졸 유도체 (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS) ⤷  Try a Trial
Hong Kong 1200162 作為具有激酶抑制劑活性的取代的吲唑衍生物 (SUBSTITUTED INDAZOLE DERIVATIVES ACTIVE AS KINASE INHIBITORS) ⤷  Try a Trial
South Korea 102151963 ⤷  Try a Trial
New Zealand 722405 Compounds for treating patients with ros1 mutant cancer cells ⤷  Try a Trial
Japan 2019516749 N−[5−(3,5−ジフルオロ−ベンジル)−1H−インダゾール−3−イル]−4−(4−メチル−ピペラジン−1−イル)−2−(テトラヒドロ−ピラン−4−イルアミノ)−ベンズアミドの新規結晶形 ⤷  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 C202030070 Spain ⤷  Try a Trial 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
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
3107541 132021000000107 Italy ⤷  Try a Trial 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
3107541 122021000032 Germany ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB IN ALLEN DEM GRUNDPATENT ZUGRUNDE LIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/20/1460 20200731
3107541 21/2021 Austria ⤷  Try a Trial PRODUCT NAME: ENTRECTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1460 (MITTEILUNG) 20200803
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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