Piqray is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed in 2019 out of which none have expired yet. Piqray's patents have been open to challenges since 25 May, 2023. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 29, 2033. Details of Piqray'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. | |||
| US8227462 | Pyrrolidine-1,2-dicarboxamide derivatives |
Apr, 2033
(6 years from now) | Active |
| US8476268 | Pyrrolidine-1,2-dicarboxamide derivatives |
Sep, 2029
(2 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 Piqray's patents.
Latest Legal Activities on Piqray's Patents
Given below is the list of recent legal activities going on the following patents of Piqray.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Dec, 2024 | US8476268 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Jan, 2024 | US8227462 |
| Electronic Review
Critical | 29 May, 2023 | US8227462 |
| Patent Term Extension Certificate
Critical | 22 May, 2023 | US8227462 |
| Notice of Final Determination -Eligible | 18 Oct, 2022 | US8227462 |
| Withdrawal of Application for PTE
Critical | 02 Sep, 2022 | US8476268 |
| Notice of Final Determination -Election Required | 01 Aug, 2022 | US8476268 |
| Notice of Final Determination -Election Required | 01 Aug, 2022 | US8227462 |
| FDA Final Eligibility Letter
Critical | 03 Mar, 2022 | US8227462 |
| FDA Final Eligibility Letter
Critical | 03 Mar, 2022 | US8476268 |
FDA has granted several exclusivities to Piqray. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Piqray, 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
Piqray.
Exclusivity Information
Piqray holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Piqray's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 24, 2024 |
| New Indication(I-937) | Jan 18, 2027 |
US patents provide insights into the exclusivity only within the United States, but
Piqray 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 Piqray's family patents as well as insights into
ongoing legal events
on those patents.
Piqray's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Piqray:
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:
Piqray's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 29, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Piqray Generics:
There are no approved generic versions for Piqray as of now.
Alternative Brands for Piqray
Piqray which is used for treating HR-positive, HER-2-negative, PIK3CA-mutated advanced or metastatic breast cancer in combination with fulvestrant., has several other brand drugs using the same active ingredient (Alpelisib). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Novartis |
|
About Piqray
Piqray is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating HR-positive, HER-2-negative, PIK3CA-mutated advanced or metastatic breast cancer in combination with fulvestrant. Piqray uses Alpelisib as an active ingredient. Piqray was launched by Novartis in 2019.
Approval Date:
Piqray was approved by FDA for market use on 24 May, 2019.
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 Piqray is 24 May, 2019, its NCE-1 date is estimated to be 25 May, 2023.
Active Ingredient:
Piqray uses Alpelisib as the active ingredient. Check out other Drugs and Companies using Alpelisib ingredient
Treatment:
Piqray is used for treating HR-positive, HER-2-negative, PIK3CA-mutated advanced or metastatic breast cancer in combination with fulvestrant.
Dosage:
Piqray is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |