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ENTRECTINIB - Generic Drug Details
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What are the generic drug sources for entrectinib and what is the scope of freedom to operate?
Entrectinib
is the generic ingredient in one branded drug marketed by Genentech Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Entrectinib has one hundred and two patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for ENTRECTINIB
| International Patents: | 102 |
| US Patents: | 12 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 44 |
| Clinical Trials: | 18 |
| Patent Applications: | 363 |
| 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 |
|---|---|
| Hoffmann-La Roche | Phase 3 |
| Intergroupe Francophone de Cancerologie Thoracique | Phase 2 |
| Genentech, Inc. | Phase 1/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 | Start Trial | Start Trial | Start Trial | ||||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-002 | Aug 15, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Genentech Inc | ROZLYTREK | entrectinib | CAPSULE;ORAL | 212725-001 | Aug 15, 2019 | RX | Yes | No | Start Trial | Start Trial | Start 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 ENTRECTINIB
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2019516749 | Start Trial |
| European Patent Office | 3290414 | Start Trial |
| China | 103923072 | Start Trial |
| Taiwan | 201400479 | Start Trial |
| Japan | 2015517551 | Start Trial |
| Ukraine | 118773 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
