Truqap Patent Expiration

Truqap is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 8 US drug patents filed in 2023 out of which none have expired yet. Truqap's patents will be open to challenges from 17 November, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 16, 2033. Details of Truqap'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.
US9487525 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl) piperidine-4-carboxamide
Apr, 2033

(8 years from now)

Active
US8101623 Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor
Mar, 2030

(5 years from now)

Active
US10059714 Protein kinase B inhibitors
Oct, 2028

(4 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).
US10039766 Crystalline forms of (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d] pyrimidin-4-y1) piperidine-4-carboxamide
Apr, 2033

(8 years from now)

Active
US11760760 Protein kinase B inhibitors
Oct, 2028

(4 years from now)

Active
US10654855 Protein kinase B inhibitors
Oct, 2028

(4 years from now)

Active
US8809336 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors
Oct, 2025

(1 year, 17 days from now)

Active
US9006430 Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein
Oct, 2025

(1 year, 17 days 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 Truqap's patents.

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

Activity Date Patent Number
Patent litigations
Second letter to regulating agency to determine regulatory review period 16 May, 2024 US10059714
Second letter to regulating agency to determine regulatory review period 16 May, 2024 US8101623
Letter from FDA or Dept of Agriculture re PTE application 08 May, 2024 US8101623
Letter from FDA or Dept of Agriculture re PTE application 08 May, 2024 US10059714
Payment of Maintenance Fee, 8th Year, Large Entity 24 Apr, 2024 US9487525
Initial letter Re: PTE Application to regulating agency 30 Jan, 2024 US10059714
Initial letter Re: PTE Application to regulating agency 30 Jan, 2024 US8101623
Resp. to req. for info. sent under 37 CFR 1.750 29 Jan, 2024 US10059714
Resp. to req. for info. sent under 37 CFR 1.750 29 Jan, 2024 US8101623
Requirement for information sent under 37 CFR 1.750 17 Jan, 2024 US8101623


FDA has granted several exclusivities to Truqap. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Truqap, 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 Truqap.

Exclusivity Information

Truqap holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Truqap's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Nov 16, 2028

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Truqap 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 Truqap's family patents as well as insights into ongoing legal events on those patents.

Truqap's Family Patents


Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


Generic Launch

Generic Release Date:

Truqap's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 16, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Truqap Generics:

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





About Truqap

Truqap is a drug owned by Astrazeneca Pharmaceuticals Lp. It is used for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic alterations after progression on endocrine therapy in the metastatic setting or recurrence within 12 months of adjuvant therapy. Truqap uses Capivasertib as an active ingredient. Truqap was launched by Astrazeneca in 2023.

Approval Date:

Truqap was approved by FDA for market use on 16 November, 2023.

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 Truqap is 16 November, 2023, its NCE-1 date is estimated to be 17 November, 2027.

Active Ingredient:

Truqap uses Capivasertib as the active ingredient. Check out other Drugs and Companies using Capivasertib ingredient

Treatment:

Truqap is used for treating HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic alterations after progression on endocrine therapy in the metastatic setting or recurrence within 12 months of adjuvant therapy.

Dosage:

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

Strength Dosage Form Availability Application Pathway
200MG TABLET Prescription ORAL
160MG TABLET Prescription ORAL