Jaypirca is a drug owned by Loxo Oncology Inc. It is protected by 7 US drug patents filed from 2023 to 2025 out of which none have expired yet. Jaypirca's patents will be open to challenges from 27 January, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 14, 2041. Details of Jaypirca'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. | |||
| US12220401 | Compounds useful as kinase inhibitors |
Dec, 2036
(10 years from now) | Active |
| US10695323 | Compounds useful as kinase inhibitors |
Dec, 2036
(10 years from now) | Active |
| US10342780 | Compounds useful as kinase inhibitors |
Dec, 2036
(10 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). | |||
| US12109193 | Spray-dried dispersions, formulations, and polymorphs of (s)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide |
Sep, 2041
(14 years from now) | Active |
| US12268666 | Spray-dried dispersions, formulations, and polymorphs of (S)-5-amino-3-(4-((5-fluoro-2-methoxybenzamido)methyl)phenyl)-1-(1,1,1-trifluoropropan-2-yl)-1H-pyrazole-4-carboxamide |
Jul, 2039
(12 years from now) | Active |
| US10464905 | Compounds useful as kinase inhibitors |
Dec, 2036
(10 years from now) | Active |
| US10918622 | Compounds useful as kinase inhibitors |
Dec, 2036
(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 Jaypirca's patents.
Latest Legal Activities on Jaypirca's Patents
Given below is the list of recent legal activities going on the following patents of Jaypirca.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| FDA Final Eligibility Letter | 17 Dec, 2025 | US10342780 |
| transaction for FDA Determination of Regulatory Review Period | 12 May, 2025 | US10342780 |
| Sequence Moved to Public Database | 10 Apr, 2025 | US12268666 |
| Recordation of Patent Grant Mailed | 08 Apr, 2025 | US12268666 |
| Patent Issue Date Used in PTA Calculation | 08 Apr, 2025 | US12268666 |
| Email Notification | 08 Apr, 2025 | US12268666 |
| Recordation of Patent eGrant | 08 Apr, 2025 | US12268666 |
| Mail Patent eGrant Notification | 08 Apr, 2025 | US12268666 |
| Patent eGrant Notification | 08 Apr, 2025 | US12268666 |
| transaction for FDA Determination of Regulatory Review Period | 27 Mar, 2025 | US10342780 |
FDA has granted several exclusivities to Jaypirca. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Jaypirca, 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
Jaypirca.
Exclusivity Information
Jaypirca holds 5 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Jaypirca's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 27, 2028 |
| New Indication(I-981) | Dec 02, 2028 |
| Orphan Drug Exclusivity(ODE-424) | Jan 27, 2030 |
| Orphan Drug Exclusivity(ODE-451) | Dec 01, 2030 |
| Orphan Drug Exclusivity(ODE-518) | Dec 03, 2032 |
US patents provide insights into the exclusivity only within the United States, but
Jaypirca 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 Jaypirca's family patents as well as insights into
ongoing legal events
on those patents.
Jaypirca's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Jaypirca:
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:
Jaypirca's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 14, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jaypirca Generics:
There are no approved generic versions for Jaypirca as of now.
About Jaypirca
Jaypirca is a drug owned by Loxo Oncology Inc. It is used for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor. Jaypirca uses Pirtobrutinib as an active ingredient. Jaypirca was launched by Loxo Oncol in 2023.
Approval Date:
Jaypirca was approved by FDA for market use on 27 January, 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 Jaypirca is 27 January, 2023, its NCE-1 date is estimated to be 27 January, 2027.
Active Ingredient:
Jaypirca uses Pirtobrutinib as the active ingredient. Check out other Drugs and Companies using Pirtobrutinib ingredient
Treatment:
Jaypirca is used for treating adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma who have received at least two prior lines of therapy including a BTK inhibitor and a BCL-2 inhibitor.
Dosage:
Jaypirca 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 |
| 100MG | TABLET | Prescription | ORAL |