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PIQRAY Drug Profile
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» See Plans and PricingWhich patents cover Piqray, and when can generic versions of Piqray launch?
Piqray is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.
This drug has fifty patent family members in forty-three countries.
The generic ingredient in PIQRAY is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
US ANDA Litigation and Generic Entry Outlook for Piqray
Piqray will be eligible for patent challenges on May 24, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 28, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for PIQRAY
| International Patents: | 50 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 55 |
| Clinical Trials: | 1 |
| Patent Applications: | 110 |
| Drug Prices: | Drug price information for PIQRAY |
| DailyMed Link: | PIQRAY at DailyMed |
Generic Entry Opportunity Date for PIQRAY
Generic Entry Date for PIQRAY*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for PIQRAY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
US Patents and Regulatory Information for PIQRAY
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | May 24, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for PIQRAY
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1117078 | Start Trial |
| Chile | 2011000504 | Start Trial |
| Denmark | 2331537 | Start Trial |
| San Marino | AP201100019 | Start Trial |
| Morocco | 32604 | Start Trial |
| Montenegro | 01284 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
