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Last Updated: June 27, 2022

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

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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
Drug patent expirations by year for PIQRAY
Drug Prices for PIQRAY

See drug prices for PIQRAY

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

SponsorPhase
Novartis Pharma B.V.Phase 2
BOOG Study CenterPhase 2
Borstkanker Onderzoek GroepPhase 2

See all PIQRAY clinical trials

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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.