Repotrectinib - Generic Drug Details
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What are the generic sources for repotrectinib and what is the scope of freedom to operate?
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: | 7 |
| 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 |
|---|---|
| Memorial Sloan Kettering Cancer Center | Phase 1/Phase 2 |
| Turning Point Therapeutics, Inc. | Phase 1 |
| Instituto Oncológico Dr Rosell | Phase 1 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Bristol | AUGTYRO | repotrectinib | CAPSULE;ORAL | 218213-001 | Nov 15, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for repotrectinib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112018000297 | polimorfo de macrociclo de diarila | ⤷ Try a Trial |
| Lithuania | 3097107 | ⤷ Try a Trial | |
| Israel | 256443 | פולימורפ מקרוציקלי דיארילי (Diaryl macrocycle polymorph) | ⤷ Try a Trial |
| Denmark | 3097107 | ⤷ Try a Trial | |
| Lithuania | 3572416 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
