Tukysa Patent Expiration

Tukysa is a drug owned by Seagen Inc. It is protected by 8 US drug patents filed from 2020 to 2024 out of which none have expired yet. Tukysa's patents have been open to challenges since 17 April, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 27, 2038. Details of Tukysa's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8648087 N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Apr, 2031

(6 years from now)

Active
US7452895 Quinazoline analogs as receptor tyrosine kinase inhibitors
Nov, 2024

(a month from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11207324 Treatment of HER2 positive cancers
Apr, 2038

(13 years from now)

Active
US11666572 Treatment of HER2 positive cancers
Apr, 2038

(13 years from now)

Active
US12048698 Treatment of HER2 positive cancers
Apr, 2038

(13 years from now)

Active
US11504370 Treatment of brain cancer
Mar, 2033

(8 years from now)

Active
US9457093 Solid dispersions of a ERB2 (HER2) inhibitor
Oct, 2032

(7 years from now)

Active
US9693989 N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
May, 2027

(2 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tukysa's patents.

Given below is the list of recent legal activities going on the following patents of Tukysa.

Activity Date Patent Number
Patent litigations
Mail Pre-Exam Notice 29 May, 2024 US9693989
Email Notification 29 May, 2024 US9693989
Change in Power of Attorney (May Include Associate POA) 29 May, 2024 US9693989
Patent eCofC Notification 16 Apr, 2024 US11666572
Email Notification 16 Apr, 2024 US11666572
Mail Patent eCofC Notification 16 Apr, 2024 US11666572
Recordation of Patent eCertificate of Correction 16 Apr, 2024 US11666572
Post Issue Communication - Certificate of Correction 29 Mar, 2024 US11666572
Payment of Maintenance Fee, 8th Year, Large Entity 14 Mar, 2024 US9457093
transaction for FDA Determination of Regulatory Review Period 30 Nov, 2023 US8648087


FDA has granted several exclusivities to Tukysa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tukysa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tukysa.

Exclusivity Information

Tukysa holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Tukysa's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Apr 17, 2025
New Indication(I-906) Jan 19, 2026
Orphan Drug Exclusivity(ODE-309) Apr 17, 2027
Orphan Drug Exclusivity(ODE-422) Jan 19, 2030

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Several oppositions have been filed on Tukysa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tukysa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tukysa patents.

Tukysa's Oppositions Filed in EPO

Tukysa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 01, 2021, by Sandoz Ag. This opposition was filed on patent number EP18162971A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP18162971A Sep, 2021 Teva Pharmaceutical Industries Ltd. Granted and Under Opposition
EP18162971A Sep, 2021 Sandoz AG Granted and Under Opposition


US patents provide insights into the exclusivity only within the United States, but Tukysa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tukysa's family patents as well as insights into ongoing legal events on those patents.

Tukysa's Family Patents

Tukysa has patent protection in a total of 43 countries. It's US patent count contributes only to 18.4% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tukysa.

Family Patents

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Generic Launch

Generic Release Date:

Tukysa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 27, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Tukysa Generics:

There are no approved generic versions for Tukysa as of now.





About Tukysa

Tukysa is a drug owned by Seagen Inc. It is used for treating advanced or metastatic colorectal cancer and breast cancer that is HER2-positive or overexpressing. Tukysa uses Tucatinib as an active ingredient. Tukysa was launched by Seagen in 2020.

Approval Date:

Tukysa was approved by FDA for market use on 17 April, 2020.

NCE-1 date:

NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Tukysa is 17 April, 2020, its NCE-1 date is estimated to be 17 April, 2024.

Active Ingredient:

Tukysa uses Tucatinib as the active ingredient. Check out other Drugs and Companies using Tucatinib ingredient

Treatment:

Tukysa is used for treating advanced or metastatic colorectal cancer and breast cancer that is HER2-positive or overexpressing.

Dosage:

Tukysa is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
50MG TABLET Prescription ORAL
150MG TABLET Prescription ORAL