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TUKYSA Drug Profile
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Which patents cover Tukysa, and what generic alternatives are available?
Tukysa is a drug marketed by Seattle Genetics and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and twenty-six patent family members in thirty-six countries.
The generic ingredient in TUKYSA is tucatinib. One supplier is listed for this compound. Additional details are available on the tucatinib profile page.
US ANDA Litigation and Generic Entry Outlook for Tukysa
Tukysa will be eligible for patent challenges on April 17, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 12, 2032. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for TUKYSA
| International Patents: | 126 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 41 |
| Clinical Trials: | 1 |
| Patent Applications: | 14 |
| Drug Prices: | Drug price information for TUKYSA |
| DailyMed Link: | TUKYSA at DailyMed |
Generic Entry Opportunity Date for TUKYSA
Generic Entry Date for TUKYSA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 TUKYSA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Seattle Genetics, Inc. | Phase 1 |
US Patents and Regulatory Information for TUKYSA
| 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 | Y | 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 | 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 TUKYSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | PA06001767 | Start Trial |
| Australia | 2012322039 | Start Trial |
| South Korea | 102000312 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
