PIQRAY Drug Patent Profile

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 sixty patent family members in fifty 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 was eligible for patent challenges on May 24, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 29, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PIQRAY

International Patents:	60
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	16
Patent Applications:	868
Drug Prices:	Drug price information for PIQRAY
What excipients (inactive ingredients) are in PIQRAY?	PIQRAY excipients list
DailyMed Link:	PIQRAY at DailyMed

See drug prices for PIQRAY

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PIQRAY

NDA:

212526

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
Columbia University	Phase 1
Stemline Therapeutics, Inc.	Phase 1/Phase 2
Celcuity, Inc.	Phase 3

See all PIQRAY clinical trials

US Patents and Regulatory Information for PIQRAY

PIQRAY is protected by two US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	May 24, 2019		RX	Yes	No			Y	Y

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cuba

Cyprus

Denmark

Dominican Republic

Ecuador

El Salvador

Eurasian Patent Organization

European Patent Office

Finland

Georgia, Republic of

Honduras

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

San Marino

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Norway	2020037
Honduras	2011000699	EL COMPUESTO (S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO EN FORMA LIBRE O DE SAL Y COMPOSICIONES Y COMPOSICION FARMACEUTICA QUE LO CONTIENE.
Colombia	6351738	COMPUESTOS ORGANICOS

Supplementary Protection Certificates for PIQRAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	20C1055	France		EPRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	122020000073	Germany		PRODUCT NAME: ALPELISIB ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 20200727; FIRST REGISTRATION: SCHWEIZ 67359 20200324
2331537	PA2020534,C2331537	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727

Market Dynamics and Financial Trajectory for PIQRAY (Alpelisib)

Introduction to PIQRAY

PIQRAY, also known as alpelisib, is a kinase inhibitor developed by Novartis for the treatment of advanced or metastatic breast cancer in adults. It is specifically indicated for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and a mutation in the PIK3CA gene, as confirmed by an FDA-approved test, after progression on or after prior endocrine therapy[1][4].

Market Size and Growth Projections

The market size for PIQRAY is expected to see significant growth in the coming years. According to DelveInsight's analysis, the market size for PIQRAY is projected to increase substantially by 2032, driven by its efficacy in treating a specific subset of breast cancer patients. The report provides sales forecasts for PIQRAY across major markets, including the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan[1].

Regional Market Performance

North America

North America, particularly the United States, holds a dominant share of the alpelisib market. This is attributed to the increasing usage of alpelisib-based molecular solutions for treating postmenopausal women and the rising number of FDA approvals for alpelisib drugs in this region. The American Cancer Society's data on increasing breast cancer cases also drives demand for PIQRAY in this region[4].

Europe

In Europe, PIQRAY sales have experienced mixed results. While sales declined in the US and Europe in the first quarter of 2024, there was growth in emerging growth markets. This decline was partly offset by strong performance in other regions[3].

Asia-Pacific

The Asia-Pacific region is expected to show a steady rise in the alpelisib market due to rising approvals for alpelisib drugs. For instance, the Philippine Food and Drug Administration approved Novartis's advanced breast cancer treatment ‘alpelisib’ in combination with fulvestrant in 2022[4].

Financial Performance

Quarterly and Annual Sales

In the third quarter of 2023, PIQRAY/Vijoice sales grew by 24% in constant currency, mainly driven by growth in the US, Emerging Growth Markets, and Europe. However, in the first quarter of 2024, PIQRAY/Vijoice sales declined by 6% in constant currency, primarily due to declines in the US and Europe, though there was growth in emerging markets[2][3].

Revenue Contribution

PIQRAY contributes to Novartis's overall revenue, although its impact is part of a broader portfolio. In the full year 2023, Novartis's net sales grew by 10% in constant currency, driven by strong performance from other key products like Entresto, Kesimpta, Kisqali, and Pluvicto. While PIQRAY's sales are significant, they are part of a larger revenue stream that includes multiple successful drugs[5].

Market Drivers and Barriers

Drivers

• Increasing Prevalence of Breast Cancer: The rising number of breast cancer cases, especially among postmenopausal women, drives the demand for targeted therapies like PIQRAY[4].
• FDA Approvals: Recent FDA approvals for alpelisib in various indications, including PIK3CA-related overgrowth spectrum (PROS), have expanded its market potential[4].
• Efficacy and Safety: PIQRAY's efficacy in treating HR+/HER2- breast cancer with a PIK3CA mutation, as demonstrated in clinical trials, is a significant driver[1].

Barriers

• Generic Competition: The erosion of sales due to generic competition for other Novartis products, such as Lucentis and Gilenya, can indirectly affect the overall financial performance of the company, though PIQRAY itself is not yet subject to generic competition[3][5].
• Regulatory and Market Access: Variations in regulatory approvals and market access across different regions can impact the sales growth of PIQRAY[1].

Competitive Landscape

PIQRAY operates in a competitive landscape within the oncology market. The report by DelveInsight provides a comprehensive competitive landscape analysis, including competitors and marketed products in the same indication. This analysis helps in understanding the market positioning and potential challenges for PIQRAY[1].

Clinical and Regulatory Status

PIQRAY has received significant regulatory approvals, including FDA approval for the treatment of advanced or metastatic breast cancer with a PIK3CA mutation. It has also been approved for the treatment of severe manifestations of PIK3CA-related overgrowth spectrum (PROS) in adults and pediatric patients aged two years and over[1][4].

Distribution and Access

PIQRAY is distributed through various channels, including drug stores, mail order pharmacies, and online platforms. The accessibility of PIQRAY is crucial for its market success, and Novartis has been working to ensure its availability across different regions[4].

Future Outlook

The future outlook for PIQRAY is promising, driven by its unique mechanism of action and the growing demand for targeted cancer therapies. As more patients are diagnosed with HR+/HER2- breast cancer and tested for PIK3CA mutations, the market potential for PIQRAY is expected to expand.

"PIQRAY is serving as a beacon of hope for the patients suffering from the ER+ve HER2-ve Breast Cancer," highlighting its critical role in treating a specific subset of breast cancer patients[1].

Key Takeaways

• Market Growth: The market size for PIQRAY is expected to increase significantly by 2032, driven by its efficacy and growing demand.
• Regional Performance: North America dominates the market, while the Asia-Pacific region shows promising growth.
• Financial Performance: PIQRAY contributes to Novartis's revenue, though its sales have seen mixed results in different quarters and regions.
• Market Drivers: Increasing breast cancer prevalence, FDA approvals, and efficacy are key drivers.
• Competitive Landscape: PIQRAY operates in a competitive oncology market, with a strong market positioning due to its unique indication.

FAQs

What is PIQRAY used for?

PIQRAY (alpelisib) is used to treat advanced or metastatic breast cancer in adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer, and a mutation in the PIK3CA gene[1].

What are the key regions driving the PIQRAY market?

North America, particularly the United States, and the Asia-Pacific region are key drivers of the PIQRAY market[4].

How has PIQRAY performed financially in recent quarters?

PIQRAY sales have shown mixed results, with growth in some quarters and declines in others, primarily due to regional variations[2][3].

What are the main market drivers for PIQRAY?

The main market drivers include the increasing prevalence of breast cancer, FDA approvals, and the efficacy of PIQRAY in treating HR+/HER2- breast cancer with a PIK3CA mutation[1][4].

What is the competitive landscape for PIQRAY?

PIQRAY operates in a competitive oncology market, but its unique indication and regulatory approvals give it a strong market positioning[1].

Sources

1. DelveInsight: "PIQRAY Market Forecast" - DelveInsight's analysis includes market trends, growth projections, and key factors influencing the market dynamics[1].
2. Novartis Q3 2023 Condensed Interim Financial Report: Financial report detailing PIQRAY sales and overall company performance[2].
3. Novartis Condensed Interim Financial Report – Supplementary Data: Financial report providing detailed sales data and market performance for PIQRAY[3].
4. Alpelisib Market Size and Share: Report providing market size, share, and growth projections for alpelisib (PIQRAY)[4].
5. Novartis Financial Results Q4 2023: Financial report detailing overall company performance and sales data for PIQRAY[5].