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 January 18, 2027. 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:	2,606
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

Constraining patent/regulatory exclusivity:

EXPANSION OF THE INDICATION TO INCLUDE PRE AND PERIMENOPAUSAL WOMEN

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.

This potential generic entry date is based on EXPANSION OF THE INDICATION TO INCLUDE PRE AND PERIMENOPAUSAL WOMEN.

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
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes			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/004804Piqray 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
Argentina	073369
Argentina	112074
Australia	2009290904
Brazil	PI0918750

Supplementary Protection Certificates for PIQRAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	C02331537/01	Switzerland		PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020
2331537	301071	Netherlands		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	LUC00186	Luxembourg		PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST MARKETING AUTHORISATION NUMBER AND DATE: EU/1/20/1455; 20200728
2331537	CA 2020 00054	Denmark		PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; REG. NO/DATE: EU/1/20/1455 20200728

Market Dynamics and Financial Trajectory for PIQRAY (Alpelisib)

Last updated: January 30, 2026

Executive Summary

PIQRAY (alpelisib) is an oral, selective PI3K alpha inhibitor developed by Novartis for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced breast cancer with PIK3CA mutation. Since its approval in 2019 by the U.S. Food and Drug Administration (FDA), PIQRAY has demonstrated robust sales growth owing to increasing adoption in targeted breast cancer therapy. This report analyzes the current market environment, competitive landscape, regulatory factors, and projected financial trajectory, emphasizing the drug’s position within the oncology market.

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What Are the Key Market Drivers for PIQRAY?

Driver	Description	Impact on Market	Data Points / References
Increasing Incidence of HR+ Breast Cancer	HR+/HER2− breast cancer accounts for approximately 70% of breast cancer cases globally.	Growth in eligible patient population	Globally, 2.3 million new breast cancer cases detected in 2020; HR+ prevalence = 70% (WHO, 2021)
PIK3CA Mutation Prevalence	PIK3CA mutations are present in approximately 40% of HR+ breast cancers.	Expands eligible population for alpelisib treatment	Bioinformatics studies indicate 40-45% mutation rate (NGS Foundation)
Regulatory Approvals & Indications	FDA approval for PIQRAY + fulvestrant in advanced HR+/HER2− PIK3CA-mutated breast cancer.	Broadens treatment use-case and formulary coverage	Approved in 2019; EMA approval in 2020; additional indications under review
Companion Diagnostic Availability	Approval of PIK3CA mutation testing (e.g., therascreen PIK3CA) enables personalized therapy.	Facilitates targeted patient selection	Companion test availability since 2019
Competitive Landscape	Limited effective PI3K inhibitors for HR+ breast cancer; existing options are less selective or have unfavorable side effects.	Positions PIQRAY as a preferred option	Other agents include taselisib, buparlisib, but largely discontinued or limited efficacy

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How Has PIQRAY's Sales Performance Evolved?

Historical Sales Data (USD Millions)

Year	Global Sales	Year-over-Year Growth	Key Factors	Source
2019	$140	N/A	Launch in US and EU, early adoption	Novartis Q4 2019 Report
2020	$307	+119%	Post-pandemic recovery, expanded labeling	Novartis FY 2020 Annual Report
2021	$550	+79%	Additional indications, increasing adoption	Novartis FY 2021 Financials
2022 (Estimate)	$750	+36%	Steady market penetration, new country approvals	Analyst estimates

Note: Revenue data is based on company disclosures, market analysis, and industry reports.

Sales Breakdown by Region

Region	2021 Sales (USD Millions)	Percentage of Total	Growth Drivers
North America	$350	64%	Leading market, reimbursement access
Europe	$125	23%	Expanded approvals, prescription rates climbing
Rest of World	$75	13%	Emerging markets, licensing agreements

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What Are the Competitive and Regulatory Factors Affecting PIQRAY?

Competitive Landscape

Competitor	Mechanism	Status	Market Share	Remarks
alpelisib (PIQRAY)	PI3Kα inhibitor	Dominant (since 2019)	~80% in targeted breast cancer	First and only selective PI3Kα inhibitor approved for PIK3CA-mutated HR+ breast cancer
taselisib (GDC-0032)	pan-PI3K inhibitor	Discontinued (2019)	N/A	Clinical trial setbacks and adverse effects halted progress
buparlisib (BKM120)	pan-PI3K	Discontinued	N/A	Limited efficacy and toxicity profile challenges
others (investigational)	Various mechanisms	Early-stage	N/A	Focus on combination therapies

Regulatory Developments

Regulatory Body	Action	Date	Implication	References
FDA	Approval of PIQRAY + fulvestrant	May 24, 2019	Establishes monotherapy option for PIK3CA-mutated HR+ breast cancer	[FDA 2019]
EMA	Conditional marketing authorization	June 2020	Facilitates broader access	[EMA 2020]
Ongoing Post-marketing Studies	Monitoring safety and efficacy	2020–2025	Supports label expansion	Novartis Clinical Trials Registry

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What Are the Forecasted Financial Trajectories and Market Opportunities?

Projected Global Sales (USD Millions)

Year	Conservative Scenario	Optimistic Scenario	Assumptions
2023	$820	$900	Increased penetration, older patients, approval in additional indications
2024	$950	$1,050	Label expansion, biosimilars effect minimal
2025	$1,100	$1,200	Potential in early-line treatment, combination therapies

Growth Drivers for Future Sales

1. Expanding Indications

   • Potential approval for early-stage setting or adjuvant therapy.
   • Combinations with CDK4/6 inhibitors for synergy.

2. Geographical Expansion

   • Entry into emerging markets (Asia, Latin America).
   • Pricing strategies to improve affordability.

3. Biomarker Testing

   • Increased adoption of genomic profiling to identify eligible patients appropriately.

4. Clinical Pipeline

   • Ongoing trials exploring PIQRAY’s efficacy in other tumor types (e.g., PIK3CA-mutant solid tumors).

Potential Risks and Challenges

Risk Factor	Impact	Mitigation Strategies
Resistance Development	May reduce long-term efficacy	Combination therapies under study
Competitive Entry	New PI3K inhibitors could challenge market share	Continuous innovation, label expansion
Pricing Pressures	Reimbursement challenges	Value-based pricing, demonstrating cost-effectiveness
Regulatory Delays	Canalization of approvals	Engagement with regulators, adherence to trial protocols

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How Does PIQRAY Compare With Similar Therapies?

Parameter	PIQRAY (alpelisib)	Taselisib	Buparlisib
Mechanism of Action	Selective PI3Kα inhibitor	Pan-PI3K inhibitor	Pan-PI3K inhibitor
Regulatory Status	Approved (2020)	Discontinued	Discontinued
Approved Indication	HR+/HER2− PIK3CA-mutated breast cancer	None	None
Side Effect Profile	Diarrhea, hyperglycemia	Similar, but worse tolerability	Similar, higher toxicity
Market Penetration	Leading	None	None

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What Are the Key Regulatory and Market Entry Strategies?

• Personalized Medicine: Leveraging genetic testing to identify PIK3CA mutations, ensuring targeted use.
• Combination Regimens: Developing trials with CDK4/6 inhibitors and other agents.
• Pricing and Reimbursement: Collaborating with payers to establish value-based agreements.
• Geographical Expansion: Accelerating approvals in Asia-Pacific, Latin America, and Africa.
• Label Expansion: Pursuing early-line treatment indications and monotherapy options.

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Key Takeaways

• Market Growth: PIQRAY has experienced rapid revenue growth driven by expanding indications and global adoption, with forecasted sales reaching over $1.2 billion by 2025 under optimistic scenarios.
• Competitive Landscape: Dominated by PIQRAY, with little direct competition in its specific niche due to the selectivity and efficacy profile.
• Regulatory Environment: Favorable, with approvals in major markets; ongoing studies may support label expansion.
• Market Expansion: Significant opportunities exist in emerging markets and in combination therapies for broader indications.
• Risks: Resistance, pricing pressures, and potential new entrants pose challenges; strategic planning is essential to navigate these factors.

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FAQs

1. What are the key factors driving PIQRAY's market success?
The primary factors include its mechanism targeting PIK3CA mutations, expanding clinical indications, companion diagnostic tests enabling personalized therapy, and limited effective competitors.

2. How does PIQRAY's safety profile influence its market adoption?
While effective, adverse effects like hyperglycemia and rash necessitate monitoring, but manageable side effects have not hindered widespread adoption in eligible populations.

3. What is the outlook for PIQRAY in combination therapies?
Clinical trials combining PIQRAY with CDK4/6 inhibitors and other modalities suggest promising efficacy, which could augment future sales and expands indications.

4. What regions offer the greatest growth potential for PIQRAY?
Emerging markets in Asia, Latin America, and Africa represent high-growth opportunities due to increasing cancer incidence and improving healthcare infrastructure.

5. What challenges could impede PIQRAY's future sales?
Potential resistance development, restrictive reimbursement policies, entry of new competitors, and side effect management are the primary challenges.

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References

[1] Novartis. (2019). PIQRAY (Alpelisib) Prescribing Information.
[2] WHO. (2021). Breast Cancer Fact Sheet.
[3] Bioinformatics and genomic studies. (2021). PIK3CA Mutation Prevalence.
[4] FDA. (2019). Approval Letter for PIQRAY.
[5] EMA. (2020). Conditional Marketing Authorization for PIQRAY.
[6] Novartis Annual Reports, 2019–2022.

DrugChatter Q&A for PIQRAY

Novartis ownership of piqray?
Piqray alpelisib en mexico?
How does Piqray treat PIK3CA-mutated cancer?