Truseltiq Patent Expiration

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.

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

Activity Date Patent Number
Patent litigations
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 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

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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

Truseltiq has patent protection in a total of 41 countries. It's US patent count contributes only to 10.8% of its total global patent coverage. 4 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 Truseltiq.

Family Patents

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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