Generic Tukysa Availability
Last updated on May 7, 2025.
Tukysa is a brand name of tucatinib, approved by the FDA in the following formulation(s):
TUKYSA (tucatinib - tablet;oral)
Is there a generic version of Tukysa available?
No. There is currently no therapeutically equivalent version of Tukysa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tukysa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Treatment of HER2 positive cancers
Patent 11,207,324
Issued: December 28, 2021
Inventor(s): Peterson Scott & Walker Luke
Assignee(s): Seagen Inc.In one aspect, the present invention provides a method for treating or ameliorating the effects of a HER2 positive cancer in a subject. In some embodiments, the method comprises administering a combination therapy comprising an anti-HER2 antibody and tucatinib. In some embodiments, the method further comprises administering a chemotherapeutic agent (e.g., an antimetabolite) to the subject. Pharmaceutical compositions and kits are also provided herein.
Patent expiration dates:
- April 27, 2038✓
- April 27, 2038
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Treatment of brain cancer
Patent 11,504,370
Issued: November 22, 2022
Inventor(s): Lee; Patrice A. et al.
Assignee(s): ARRAY BIOPHARMA INC. (Boulder, CO)Compounds for the treatment of brain cancer are provided herein. Pharmaceutical compositions comprised of those compounds for the treatment of brain cancer are also provided herein.
Patent expiration dates:
- March 25, 2033✓
- March 25, 2033
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Treatment of HER2 positive cancers
Patent 11,666,572
Issued: June 6, 2023
Inventor(s): Peterson; Scott et al.
Assignee(s): Seagen Inc. (Bothell, WA)In one aspect, the present invention provides a method for treating or ameliorating the effects of a HER2 positive cancer in a subject. In some embodiments, the method comprises administering a combination therapy comprising an anti-HER2 antibody and tucatinib. In some embodiments, the method further comprises administering a chemotherapeutic agent (e.g., an antimetabolite) to the subject. Pharmaceutical compositions and kits are also provided herein.
Patent expiration dates:
- April 27, 2038✓
- April 27, 2038
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Treatment of HER2 positive cancers
Patent 12,048,698
Issued: July 30, 2024
Inventor(s): Peterson; Scott et al.
Assignee(s): Seagen Inc. (Bothell, WA)In one aspect, the present invention provides a method for treating or ameliorating the effects of a HER2 positive cancer in a subject. In some embodiments, the method comprises administering a combination therapy comprising an anti-HER2 antibody and tucatinib. In some embodiments, the method further comprises administering a chemotherapeutic agent (e.g., an antimetabolite) to the subject. Pharmaceutical compositions and kits are also provided herein.
Patent expiration dates:
- April 27, 2038✓
- April 27, 2038
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Quinazoline analogs as receptor tyrosine kinase inhibitors
Patent 7,452,895
Issued: November 18, 2008
Inventor(s): Wallace; Eli et al.
Assignee(s): Array BioPharma Inc. (Boulder, CO)This invention provides quinazoline analogs of Formula I: ##STR00001## where A is bonded to at least one of the carbons at the 5, 6, 7 or 8 position of the bicyclic ring, and the ring is substituted by up to two independent R.sup.3 groups. The invention also includes methods of using compounds of Formula I as type I receptor tyrosine kinase inhibitors and for the treatment of hyperproliferative diseases such as cancer.
Patent expiration dates:
- November 16, 2025✓✓✓
- November 16, 2025✓✓✓
- November 16, 2025
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N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Patent 8,648,087
Issued: February 11, 2014
Inventor(s): Lyssikatos Joseph P. & Greschuk Julie Marie & Marmsäter Fredrik P. & Zhao Qian & Hennings D. David & Liu Weidong
Assignee(s): Array Biopharma, Inc.This invention provides compounds of Formula I
Patent expiration dates:
- April 12, 2031✓✓
- April 12, 2031
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Solid dispersions of a ERB2 (HER2) inhibitor
Patent 9,457,093
Issued: October 4, 2016
Inventor(s): Fry David Shank & Lindemann Christopher M. & Preigh Michael & Bloom Corey Jay & Craig Christopher Donovan & Dubose Devon Brevard & Gautschi Jeff & Smithey Dan
Assignee(s): Array BioPharma Inc.A solid dispersion of N4-(4-([1,2,4]triazolo[1,5-a]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine and processes for preparing the solid dispersion are provided herein. Also, a pharmaceutical composition comprising a solid dispersion of N4-(4-([1,2,4]triazolo[1,5-α]pyridin-7-yloxy)-3-methylphenyl)-N6-(4,4-dimethyl-4,5-dihydrooxazol-2-yl)quinazoline-4,6-diamine and uses thereof are provided herein.
Patent expiration dates:
- October 12, 2032✓✓
- October 12, 2032
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N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Patent 9,693,989
Issued: July 4, 2017
Inventor(s): Lyssikatos Joseph P. & Hicks Julie Marie & Marmsater Fredrik P. & Zhao Qian
Assignee(s): Array Biopharma, Inc.This invention provides compounds of Formula I
Patent expiration dates:
- May 9, 2027✓✓
- May 9, 2027
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- April 17, 2025 - NEW CHEMICAL ENTITY
- January 19, 2026 - TUCATINIB IN COMBINATION WITH TRASTUZUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE, UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASE
- April 17, 2027 - INDICATED FOR USE IN COMBINATION WITH TRASTUZUMAB AND CAPECITABINE FOR TREATMENT OF ADULT PATIENTS WITH METASTATIC HER2-POSITIVE BREAST CANCER AND BRAIN METASTASES, WHO HAVE RECEIVED ONE OR MORE PRIOR ANTI-HER2-BASED REGIMENS IN THE METASTATIC SETTING
- January 19, 2030 - TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY
More about Tukysa (tucatinib)
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
