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
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No

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
Canada	2734819
Chile	2011000504

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
2331537	PA2020534	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537	2020C/547	Belgium		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728

PIQRAY (alpelisib) Market Dynamics and Financial Trajectory: Revenue Drivers, Exclusivity Timeline, Competitive Pressure, and Profitability Outlook

Last updated: July 7, 2026

How has PIQRAY (alpelisib) performed commercially since launch?

PIQRAY (alpelisib) is the trade name for alpelisib, a PI3Kα inhibitor marketed by Novartis for HR+/HER2− PIK3CA-mutated advanced or metastatic breast cancer in combination with fulvestrant, after endocrine therapy. Commercial trajectory is shaped by (1) targeted biomarker access (PIK3CA mutation testing), (2) payer coverage rules and step-edits, (3) toxicity management economics (notably hyperglycemia and rash), and (4) competitive second-line positioning as other endocrine-PI3K or endocrine-CDK4/6 strategies evolve.

Commercial base and pull-through mechanics (targeted oncology):

• Patient identification bottleneck: Only patients with PIK3CA mutations are eligible for PIQRAY + fulvestrant under label requirements, creating a structurally smaller addressable market than non-biomarker endocrine therapy.
• Toxicity and monitoring cost offsets: Real-world uptake depends on ability to manage hyperglycemia, rash, and dose interruptions and reductions. Payers typically tie coverage to adherence to monitoring protocols and dose management.
• Sequence effects: Uptake is sensitive to the sequencing of endocrine-based regimens in HR+/HER2− metastatic breast cancer, where CDK4/6 inhibitors and other targeted options can reduce need for earlier PI3K use.

What are the key market dynamics that drive PIQRAY demand?

1) Biomarker penetration and test availability

• Growth in testing for PIK3CA mutations expands the population that can be identified for eligibility.
• Centers using comprehensive genomic profiling typically improve test turnaround and conversion to treatment.

2) Payer and formulary dynamics

• Coverage tends to be restricted to the labeled population and often requires documentation of:
  • HR+/HER2− status
  • PIK3CA mutation
  • prior endocrine therapy
• Non-covered patients can remain “institutional exceptions,” limiting scalability.

3) Clinical practice pattern: toxicity-driven discontinuation risk

• Real-world persistence is a commercial KPI because PI3K inhibition is associated with metabolic and dermatologic adverse events. Those events impact:
  • dose continuity
  • discontinuation probability
  • patient referral to alternative therapies when toxicity is unacceptable

4) Competitive environment

• Competition comes less from “same mechanism, same line” drugs and more from expanding endocrine and targeted combinations that keep patients on longer, better-tolerated regimens.
• Over time, any improvement in endocrine sequencing or alternative pathway targeting compresses the number of eligible patients reaching PIQRAY in later lines.

How does PIQRAY’s financial trajectory compare with other HR+/HER2− metastatic breast cancer targeted oncology launches?

PIQRAY’s financial arc is typical for biomarker-defined targeted oncology:

• Early ramp depends on oncologist adoption and payer approvals for the biomarker-defined subgroup.
• Sustained growth depends on persistence and conversion from initial use to ongoing therapy.
• Mid-life stagnation risk rises when:
  • formulary restrictions tighten
  • toxicity drives discontinuation
  • competing regimens gain share through favorable tolerability or earlier-line positioning

For Bloomberg-style decisioning, the key financial question is whether PIQRAY clears the “persistence hurdle” in real-world settings where treatment duration directly drives revenue more than initial prescriptions.

What is the exclusivity and patent expiration timeline that affects PIQRAY revenue?

PIQRAY revenue is exposed to multiple layers of market protection:

• Regulatory exclusivities (new chemical entity, pediatric exclusivity, marketing exclusivity) that protect against generic substitution via FDA pathways.
• Patent exclusivity based on compound, formulations, methods of use, and combination claims.

A full, accurate exclusivity map requires Orange Book patent-by-patent listing and expiration dates. No such listing data was provided in the prompt, so a complete timeline cannot be produced here.

What are the generic entry risks for PIQRAY?

Generic entry risk for PIQRAY hinges on:

• Patent cliffs in the Orange Book for:
  • alpelisib compound claims
  • fulvestrant combination use claims
  • dosing regimens and formulation claims (if applicable)
• Paragraph IV litigation that typically follows when ANDA applicants identify expiring patents.
• Non-patent barriers such as clinical practice changes and payer access rules, which can slow generic adoption even after a legal cliff.

A complete, accurate assessment of generic entry risks requires the Orange Book patent list and litigation docket status for each listed patent. No such data was provided in the prompt, so a complete risk map cannot be generated.

How do label and FDA pathway status affect PIQRAY revenue stability?

PIQRAY is a prescription oncology drug. Revenue stability depends on whether label use remains current as treatment guidelines shift. Key revenue stabilizers:

• Maintained labeled indication with continued clinical relevance in HR+/HER2− metastatic disease.
• Combination position with fulvestrant in PI3Kα-mutated disease after progression on endocrine therapy.
• Ongoing uptake under real-world eligibility criteria aligned with FDA labeling and payer requirements.

What competitive substitutes threaten PIQRAY market share?

Competitive pressure in HR+/HER2− metastatic breast cancer typically comes from:

• Other endocrine-based regimens and targeted kinase inhibitors that improve tolerability or provide better efficacy in broader patient subgroups.
• Strategy shifts that move patients away from PI3K-based treatment earlier in the disease course or replace PI3K use with alternative targeted pathways.

To quantify share loss risk, the analysis must compare:

• line-of-therapy share in PI3K-mutated subpopulations
• persistence rates and dose modification patterns across competing regimens
• payer coverage differences

No competitor market share or real-world persistence datasets were provided in the prompt.

What is the commercial impact of toxicity and management costs for PIQRAY?

PIQRAY’s economics are partly “system economics.” Commercial performance is affected by:

• Monitoring resource utilization: hyperglycemia monitoring requires lab cadence and management pathways.
• Cost of supportive meds: diabetes management and steroid or antihyperglycemic adjustments add incremental spend.
• Dose interruptions/reductions: pharmacy spend may be offset by fewer tablets per patient if dose intensity drops.
• Discontinuation: discontinuations convert revenue loss into earlier switches, compressing total treatment months.

These drivers matter for both payer formulary decisions and Novartis unit-based revenue and net price realization.

How strong is the patent estate for PIQRAY and what does it protect?

A credible patent strength view requires:

• the set of Orange Book-listed patents
• claim scope (compound versus method versus formulation versus combination)
• prosecution history and claim-construction risk
• litigation status, assignments, and expiration dates

No Orange Book data or patent listing was provided in the prompt, so this section cannot be completed without fabricating numbers.

What patent litigation affects PIQRAY and what outcomes matter for financial modeling?

Impactful outcomes in PIQRAY litigation would include:

• findings on claim validity or non-infringement
• consent judgments that set generic launch dates
• settlement agreements that determine entry timing and, in some cases, agreed launch dates for competing generics/biosimilars

No litigation docket information was provided in the prompt, so an outcomes-based litigation risk assessment cannot be produced.

What are the Key Takeaways for PIQRAY’s market and financial outlook?

• PIQRAY demand is constrained by PIK3CA mutation eligibility, making biomarker penetration and testing workflows core revenue drivers.
• Commercial performance is sensitive to toxicity-driven persistence, particularly hyperglycemia and rash, which affect treatment duration, dose intensity, and discontinuation rates.
• Competitive pressure in HR+/HER2− metastatic breast cancer increasingly comes from sequencing and tolerability advantages of alternative targeted endocrine strategies.
• A full, decision-grade exclusivity and patent cliff assessment requires Orange Book listing and litigation data, which was not provided in the prompt.

FAQs

1) What is PIQRAY (alpelisib) approved for, and how does the indication limit market size?

PIQRAY is approved for HR+/HER2− advanced or metastatic breast cancer with PIK3CA mutation, in combination with fulvestrant, after endocrine therapy. The biomarker requirement narrows eligible volume.

2) Why does PIK3CA testing matter most for PIQRAY revenue?

Because only patients with PIK3CA mutations meet label criteria, testing directly determines conversion from metastatic HR+/HER2− screening to eligible treatment.

3) Which adverse events most affect PIQRAY persistence and payer coverage?

Hyperglycemia and rash are the primary adverse events that drive monitoring, dose modifications, and discontinuations.

4) How do exclusivity and Orange Book patents determine generic entry timing?

Generic substitution timing is governed by the Orange Book patent expiration dates and the outcome of any Paragraph IV challenges tied to those patents.

5) What commercial KPI best predicts PIQRAY long-term revenue?

Treatment persistence and duration in the PI3K-mutated HR+/HER2− patient subgroup, because revenue scales with ongoing tablet use rather than initial prescriptions alone.

References

No sources were provided in the prompt, and no external citation set was generated.

DrugChatter Q&A for PIQRAY

Until when novartis has protected market for piqray in the us?
Novartis ownership of piqray?
Piqray alpelisib en mexico?
How does Piqray treat PIK3CA-mutated cancer?