Truqap is a drug owned by Astrazeneca Pharmaceuticals Lp. It is protected by 11 US drug patents filed from 2023 to 2026. Out of these, 9 drug patents are active and 2 have expired. 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
(6 years from now) | Active |
| US8101623 | Substituted pyrrolo[2,3-d]pyrimidine as a protein kinase B inhibitor |
Mar, 2030
(3 years from now) | Active |
| US10059714 | Protein kinase B inhibitors |
Oct, 2028
(2 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
(6 years from now) | Active |
| US11760760 | Protein kinase B inhibitors |
Oct, 2028
(2 years from now) | Active |
| US10654855 | Protein kinase B inhibitors |
Oct, 2028
(2 years from now) | Active |
| US9492453 | Protein Kinase B Inhibitors |
Oct, 2028
(2 years from now) | Active |
| US11236095 | Protein Kinase B Inhibitors |
Oct, 2028
(2 years from now) | Active |
| US12252495 | Protein kinase B inhibitors |
Oct, 2028
(2 years from now) | Active |
| US9006430 | Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein |
Oct, 2025
(11 months ago) |
Expired
|
| US8809336 | Ortho-condensed pyridine and pyrimidine derivatives (e.g., purines) as protein kinases inhibitors |
Oct, 2025
(11 months ago) |
Expired
|
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.
Latest 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 |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jan, 2026 | US10059714 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Jan, 2026 | US10039766 |
| transaction for FDA Determination of Regulatory Review Period | 20 Jun, 2025 | US8101623 |
| transaction for FDA Determination of Regulatory Review Period | 20 Jun, 2025 | US10059714 |
| transaction for FDA Determination of Regulatory Review Period | 02 May, 2025 | US10059714 |
| transaction for FDA Determination of Regulatory Review Period | 02 May, 2025 | US8101623 |
| Information Disclosure Statement (IDS) Filed | 02 May, 2025 | US8101623 |
| Email Notification | 18 Mar, 2025 | US12252495 |
| Recordation of Patent eGrant | 18 Mar, 2025 | US12252495 |
| Mail Patent eGrant Notification | 18 Mar, 2025 | US12252495 |
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 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. 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 |
| New Indication(I-991) | Jun 12, 2029 |
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
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Truqap:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
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 |
|---|---|---|---|
| 160MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |