DrugPatentWatch Database Preview
PIQRAY Drug Profile
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Which 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-five patent family members in forty-seven countries.
The generic ingredient in PIQRAY is alpelisib. One supplier is listed for this compound. Additional details are available on the alpelisib profile page.
DrugPatentWatch® 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: | 55 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 1 |
| Patent Applications: | 911 |
| Drug Prices: | Drug price information for PIQRAY |
| What excipients (inactive ingredients) are in PIQRAY? | PIQRAY excipients list |
| DailyMed Link: | PIQRAY at DailyMed |
DrugPatentWatch® Estimated 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 | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | May 24, 2019 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-001 | May 24, 2019 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >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 |
|---|---|---|
| Canada | 2734819 | Try Before You Buy |
| Hungary | E025884 | Try Before You Buy |
| Eurasian Patent Organization | 018863 | Try Before You Buy |
| Cyprus | 1117078 | Try Before You Buy |
| Costa Rica | 20110059 | Try Before You Buy |
| European Patent Office | 2331537 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PIQRAY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2331537 | 122020000073 | Germany | Try Before You Buy | PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1455 20200727 |
| 2331537 | CA 2020 00054 | Denmark | Try Before You Buy | PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/20/1455 20200728 |
| 2331537 | LUC00186 | Luxembourg | Try Before You Buy | PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728 |
| 2331537 | PA2020534 | Lithuania | Try Before You Buy | PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727 |
| 2331537 | 301071 | Netherlands | Try Before You Buy | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
| 2331537 | C02331537/01 | Switzerland | Try Before You Buy | PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
