REPOTRECTINIB - Generic Drug Details
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What are the generic sources for repotrectinib and what is the scope of patent protection?
Repotrectinib
is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Repotrectinib has one hundred and one patent family members in thirty-two countries.
One supplier is listed for this compound.
Summary for REPOTRECTINIB
| International Patents: | 101 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 8 |
| Patent Applications: | 59 |
| What excipients (inactive ingredients) are in REPOTRECTINIB? | REPOTRECTINIB excipients list |
| DailyMed Link: | REPOTRECTINIB at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for REPOTRECTINIB
Generic Entry Date for REPOTRECTINIB*:
Constraining patent/regulatory exclusivity:
TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ROS1-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC) WITH ADENOCARCINOMA HISTOLOGY Dosage:
CAPSULE;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 REPOTRECTINIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bristol-Myers Squibb | Phase 3 |
| Zai Lab (Shanghai) Co., Ltd. | Phase 3 |
| Memorial Sloan Kettering Cancer Center | Phase 1/Phase 2 |
US Patents and Regulatory Information for REPOTRECTINIB
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 REPOTRECTINIB
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 201612183 | Diaryl macrocycles as modulators of protein kinases | ⤷ Sign Up |
| Russian Federation | 2728579 | ХИРАЛЬНЫЕ ДИАРИЛЬНЫЕ МАКРОЦИКЛЫ И ИХ ПРИМЕНЕНИЕ (CHIRAL DIARYL MACROCYCLES AND USE THEREOF) | ⤷ Sign Up |
| Canada | 2992324 | MACROCYCLES DIARYLES CHIRAUX ET LEURS UTILISATIONS (CHIRAL DIARYL MACROCYCLES AND USES THEREOF) | ⤷ Sign Up |
| Brazil | 112018001065 | macrociclos diarila quirais e usos dos mesmos | ⤷ Sign Up |
| Peru | 20160931 | MACROCICLOS DE DIARILO COMO MODULADORES DE LA PROTEINA QUINASA | ⤷ Sign Up |
| Canada | 2936079 | MACROCYCLES DE DIARYLE EN TANT QUE MODULATEURS DE PROTEINES KINASES (DIARYL MACROCYCLES AS MODULATORS OF PROTEIN KINASES) | ⤷ Sign Up |
| Portugal | 3572416 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
