Truseltiq is a drug owned by Helsinn Healthcare Sa. It is protected by 4 US drug patents filed in 2021 out of which none have expired yet. Truseltiq's patents will be open to challenges from 28 May, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 11, 2034. Details of Truseltiq'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. | |||
| US8552002 | Compounds and compositions as protein kinase inhibitors |
Aug, 2029
(4 years from now) | Active |
| US9067896 | Crystalline forms of 3-(2,6-dichloro-3,5-dimethoxy-phenyl)-1-{6-[4-(4-ethyl-piperazin-1-yl) -phenylamino]-pyrimidin-4-yl}-1-methyl-urea and salts thereof |
Aug, 2028
(3 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10278969 | Pharmaceutical dosage forms |
Dec, 2034
(10 years from now) | Active |
| US11160804 | Pharmaceutical dosage forms |
Dec, 2034
(10 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 Truseltiq's patents.
Latest Legal Activities on Truseltiq's Patents
Given below is the list of recent legal activities going on the following patents of Truseltiq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Miscellaneous Incoming Letter | 23 May, 2024 | US8552002 |
| Letter from FDA or Dept of Agriculture re PTE application | 16 May, 2024 | US8552002 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2024 | US8552002 |
| transaction for FDA Determination of Regulatory Review Period | 07 Dec, 2023 | US8552002 |
| Second letter to regulating agency to determine regulatory review period | 09 Mar, 2023 | US8552002 |
| Letter from FDA or Dept of Agriculture re PTE application | 18 Jan, 2023 | US8552002 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Dec, 2022 | US9067896 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Nov, 2022 | US10278969 |
| Initial letter Re: PTE Application to regulating agency | 28 Jan, 2022 | US8552002 |
| Patent Issue Date Used in PTA Calculation Critical | 02 Nov, 2021 | US11160804 |
FDA has granted several exclusivities to Truseltiq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Truseltiq, 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 Truseltiq.
Exclusivity Information
Truseltiq holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Truseltiq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 28, 2026 |
| Orphan Drug Exclusivity(ODE-353) | May 28, 2028 |
US patents provide insights into the exclusivity only within the United States, but Truseltiq 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 Truseltiq's family patents as well as insights into ongoing legal events on those patents.
Truseltiq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Truseltiq's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 11, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Truseltiq Generics:
There are no approved generic versions for Truseltiq as of now.
About Truseltiq
Truseltiq is a drug owned by Helsinn Healthcare Sa. Truseltiq uses Infigratinib Phosphate as an active ingredient. Truseltiq was launched by Helsinn Hlthcare in 2021.
Approval Date:
Truseltiq was approved by FDA for market use on 28 May, 2021.
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 Truseltiq is 28 May, 2021, its NCE-1 date is estimated to be 28 May, 2025.
Active Ingredient:
Truseltiq uses Infigratinib Phosphate as the active ingredient. Check out other Drugs and Companies using Infigratinib Phosphate ingredient
Dosage:
Truseltiq is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | CAPSULE | Discontinued | ORAL |
| 25MG | CAPSULE | Discontinued | ORAL |