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Tucatinib - Generic Drug Details
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What are the generic drug sources for tucatinib and what is the scope of freedom to operate?
Tucatinib
is the generic ingredient in one branded drug marketed by Seattle Genetics and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Tucatinib has one hundred and twenty-six patent family members in thirty-six countries.
One supplier is listed for this compound.
Summary for tucatinib
| International Patents: | 126 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 12 |
| Patent Applications: | 20 |
| DailyMed Link: | tucatinib at DailyMed |
Recent Clinical Trials for tucatinib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 3 |
| Alliance for Clinical Trials in Oncology | Phase 3 |
| Seattle Genetics, Inc. | Phase 3 |
US Patents and Regulatory Information for tucatinib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Seattle Genetics | TUKYSA | tucatinib | TABLET;ORAL | 213411-002 | Apr 17, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | 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 tucatinib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 5232841 | Start Trial |
| Russian Federation | 2350605 | Start Trial |
| South Korea | 20100018079 | Start Trial |
| Lithuania | 2765990 | Start Trial |
| Costa Rica | 20140228 | Start Trial |
| Portugal | 2090575 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
