Tukysa is a drug owned by Seagen Inc. It is protected by 8 US drug patents filed from 2020 to 2024. Out of these, 7 drug patents are active and 1 has expired. 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
(5 years from now) | Active |
| US7452895 | Quinazoline analogs as receptor tyrosine kinase inhibitors |
Nov, 2024
(5 months ago) |
Expired
|
| 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
(12 years from now) | Active |
| US12048698 | Treatment of HER2 positive cancers |
Apr, 2038
(12 years from now) | Active |
| US11666572 | Treatment of HER2 positive cancers |
Apr, 2038
(12 years from now) | Active |
| US11504370 | Treatment of brain cancer |
Mar, 2033
(7 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
(1 year, 11 months 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.
Latest 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 |
|---|---|---|
 | ||
| Mail Pre-Exam Notice | 29 May, 2024 | US9693989 |
| Email Notification Critical | 29 May, 2024 | US9693989 |
| Change in Power of Attorney (May Include Associate POA) Critical | 29 May, 2024 | US9693989 |
| Patent eCofC Notification | 16 Apr, 2024 | US11666572 |
| Email Notification Critical | 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 1 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 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |