PIQRAY Drug Patent 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-six 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: | 56 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 61 |
Clinical Trials: | 10 |
Patent Applications: | 1,040 |
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 |
---|---|
Novartis Pharma B.V. | Phase 2 |
BOOG Study Center | Phase 2 |
Borstkanker Onderzoek Groep | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for PIQRAY
US Patents and Regulatory Information for PIQRAY
PIQRAY is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PIQRAY is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting PIQRAY
Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: IN COMBINATION WITH FULVESTRANT FOR TREATMENT OF POSTMENOPAUSAL WOMEN, AND MEN, WITH HR-POSITIVE, HER-2-NEGATIVE, PIK3CA-MUTATED, ADVANCED OR METASTATIC BREAST CANCER
Pyrrolidine-1,2-dicarboxamide derivatives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting PIQRAY
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-002 | May 24, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Novartis | PIQRAY | alpelisib | TABLET;ORAL | 212526-003 | May 24, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for PIQRAY
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Piqray | alpelisib | EMEA/H/C/004804 Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1). |
Authorised | no | no | no | 2020-07-27 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for PIQRAY
When does loss-of-exclusivity occur for PIQRAY?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 3369
Estimated Expiration: See Plans and Pricing
Patent: 2074
Estimated Expiration: See Plans and Pricing
Australia
Patent: 09290904
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0918750
Estimated Expiration: See Plans and Pricing
Canada
Patent: 34819
Estimated Expiration: See Plans and Pricing
Chile
Patent: 11000504
Estimated Expiration: See Plans and Pricing
China
Patent: 2149711
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 51738
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 110059
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0160014
Estimated Expiration: See Plans and Pricing
Cuba
Patent: 000
Estimated Expiration: See Plans and Pricing
Patent: 110052
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 17078
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 31537
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 011000070
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 11010880
Estimated Expiration: See Plans and Pricing
El Salvador
Patent: 11003853
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 8863
Estimated Expiration: See Plans and Pricing
Patent: 1100447
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 31537
Estimated Expiration: See Plans and Pricing
Honduras
Patent: 11000699
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 56305
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 25884
Estimated Expiration: See Plans and Pricing
Patent: 000044
Estimated Expiration: See Plans and Pricing
Israel
Patent: 0976
Estimated Expiration: See Plans and Pricing
Japan
Patent: 86601
Estimated Expiration: See Plans and Pricing
Patent: 12502080
Estimated Expiration: See Plans and Pricing
Jordan
Patent: 21
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 331537
Estimated Expiration: See Plans and Pricing
Patent: 2020534
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 1556
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 11002597
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 284
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 604
Estimated Expiration: See Plans and Pricing
Netherlands
Patent: 1071
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 0754
Estimated Expiration: See Plans and Pricing
Nicaragua
Patent: 1100049
Estimated Expiration: See Plans and Pricing
Norway
Patent: 20037
Estimated Expiration: See Plans and Pricing
Panama
Patent: 41901
Estimated Expiration: See Plans and Pricing
Peru
Patent: 110796
Estimated Expiration: See Plans and Pricing
Poland
Patent: 31537
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 31537
Estimated Expiration: See Plans and Pricing
San Marino
Patent: 201100019
Estimated Expiration: See Plans and Pricing
Patent: 01100019
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 476
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 31537
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1100699
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1290844
Estimated Expiration: See Plans and Pricing
Patent: 110038737
Estimated Expiration: See Plans and Pricing
Spain
Patent: 60673
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 53206
Estimated Expiration: See Plans and Pricing
Patent: 1014851
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 11000053
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 4147
Estimated Expiration: See Plans and Pricing
Uruguay
Patent: 096
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering PIQRAY around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Argentina | 112074 | DERIVADOS DE 2-CARBOXAMIDA-CICLOAMINO-UREA COMO INHIBIDORES DE PI-3 | See Plans and Pricing |
Japan | 2012502080 | See Plans and Pricing | |
Morocco | 32604 | مركبات عضوية | See Plans and Pricing |
San Marino | AP201100019 | Composti organici. | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PIQRAY
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2331537 | 301071 | Netherlands | See Plans and Pricing | PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728 |
2331537 | 2090050-2 | Sweden | See Plans and Pricing | PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728 |
2331537 | PA2020534 | Lithuania | See Plans and Pricing | PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727 |
2331537 | 132020000000155 | Italy | See Plans and Pricing | PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |