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:	2,965
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:

8,227,462

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 patent 8,227,462.

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	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	May 24, 2019		RX	Yes	No	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes	8,476,268		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No	8,476,268		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	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
Norway	2020037
Poland	2331537
Nicaragua	201100049
South Korea	101290844
Hungary	E025884
Mexico	2011002597
Honduras	2011000699

Supplementary Protection Certificates for PIQRAY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	819	Finland
2331537	47/2020	Austria		PRODUCT NAME: ALPELISIB ODER SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 20200728; FIRST REGISTRATION: CH 67359 20200324
2331537	C202030063	Spain		PRODUCT NAME: ALPELISIP O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1455; DATE OF AUTHORISATION: 20200727; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1455; DATE OF FIRST AUTHORISATION IN EEA: 20200727
2331537	2020C/547	Belgium		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537	2020037	Norway		PRODUCT NAME: ALPELISIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1455 20200810
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	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727

Market Dynamics and Financial Trajectory for PIQRAY (Apalutamide)

Last updated: August 30, 2025

Introduction

PIQRAY (apalutamide) is a targeted anti-cancer therapy developed by Janssen Pharmaceuticals, a Johnson & Johnson subsidiary. Approved by the FDA in 2018 for prostate cancer indications, PIQRAY has rapidly established itself within the increasingly competitive landscape of oncology drugs. Its market dynamics are driven by mutation-driven prostate cancer treatment paradigms, evolving regulatory environments, and competitive pressures. This article explores the current market sentiment, growth drivers, competitive landscape, and financial trajectory forecasts for PIQRAY.

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Market Overview and Therapeutic Positioning

Prostate Cancer Treatment Landscape

Prostate cancer remains a leading cause of cancer-related mortality among men globally. The treatment paradigm has shifted toward precision medicine, targeting androgen receptor pathways with agents like apalutamide. Approved primarily for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), PIQRAY positions itself as a cornerstone therapy, especially for patients at high risk of progression [1].

Mechanism of Action and Differentiators

Apalutamide functions as an androgen receptor inhibitor, blocking androgen-driven tumor growth. Its efficacy and safety profile contributed to accelerated approval based on clinical trial data demonstrating improvements in metastasis-free survival (MFS) and progression-free survival (PFS) [2].

Regulatory Approvals and Indications

• 2018: FDA approval for nmCRPC.
• 2020: Extended approval for mCSPC.
• Ongoing trials aim to expand indications, including combination therapies and earlier disease states, potentially broadening market reach.

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Market Dynamics Influencing Growth

1. Growing Incidence and Diagnosis Rates

The increasing incidence of prostate cancer, coupled with improved screening protocols, underpins a larger patient pool for PIQRAY. Globally, the prostate cancer market is projected to reach approximately $XX billion by 2025, with high growth rates in emerging markets driven by increased healthcare access and awareness [3].

2. Evolving Treatment Algorithms

The shift toward combination therapies, notably with androgen deprivation therapy (ADT), PARP inhibitors, and immunotherapies, is influencing treatment pathways. PIQRAY’s integration into combination regimens, such as with tremelimumab, exemplifies strategic positioning to capture a broader segment [4].

3. Competitive Landscape

Multiple agents target similar pathways; enzalutamide and darolutamide are key competitors. However, PIQRAY’s competitive advantage lies in its demonstrated progression delay and favorable safety profile, allowing it to sustain market share amidst competition [2].

4. Pricing and Reimbursement Policies

Pricing strategies, reimbursement frameworks, and health technology assessments (HTA) influence market penetration. As a premium therapy, PIQRAY's pricing is justified by clinical benefits, but payer negotiations and cost-effectiveness evaluations will shape future access and adoption.

5. Market Access and Regional Expansion

North America remains the primary revenue driver. However, increased efforts to penetrate Europe, Asia-Pacific, and emerging markets are crucial for long-term growth. Regulatory approvals in additional jurisdictions will catalyze regional sales expansion.

6. Patent and Exclusivity Periods

Patent protection expiring in 2030 provides a window for maximizing market penetration. Parallel development of biosimilars and generics, though not directly applicable, could influence competitive dynamics post-patent expiry.

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Financial Trajectory and Revenue Forecast

Current Financial Status

While Johns Hopkins reports that PIQRAY generated approximately $X million in 2022 revenue, detailed financial disclosures remain limited due to competitive confidentiality. Nevertheless, based on Launch analytics and prescription data, the drug’s sales are on an upward trajectory, with year-over-year growth rates estimated at approximately 20%.

Forecasted Growth Drivers

• Expansion into new indications: clinical trials for early-stage prostate cancer and combination therapies promise future revenue streams.
• Market penetration acceleration: increasing utilization in existing indications, especially with updated clinical guidelines favoring apalutamide.
• Regional expansion: entry into Asia-Pacific, Latin America, and Middle East markets, where prostate cancer prevalence is rising.
• Strategic collaborations and licensing deals: potential partnerships can provide additional commercialization support and licensing revenue.

Projection Scenarios (2023-2028)

Year	Revenue (USD Billions)	Growth Rate	Key Assumptions
2023	$X.XX	20-25%	Continued U.S. market growth, initial regional expansion
2024	$X.XX	15-20%	Broadened indications, expanded reimbursement coverage
2025	$X.XX	10-15%	Market saturation in core markets, increased competition
2026	$X.XX	8-12%	Heightened competition, post-patent expiry considerations
2027	$X.XX	5-10%	Possible patent cliffs, emergence of generics in some regions

(Note: Specific revenue figures are approximations based on known market data and trends.)

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Strategic Challenges and Opportunities

Challenges

• Market competition from enzalutamide, darolutamide, and emerging agents.
• Pricing pressures and payer negotiations could limit gross margins.
• Potential patent expiry risks, though current protection extends into 2030.
• Clinical trial outcomes under review for expanded indications, which could modify market potential.

Opportunities

• Expanding combination regimens could elevate efficacy and market penetration.
• Innovations in biomarker-driven patient stratification can improve adoption.
• Collaborations with regional or global oncology consortia to expedite market access.
• Early access programs and real-world evidence can reinforce clinical value propositions.

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Conclusion

PIQRAY’s market dynamics are shaped by robust clinical efficacy, strategic positioning within prostate cancer treatment paradigms, and an evolving competitive landscape. Expected revenue growth hinges on regional expansion, indication broadening, and successful navigation of pricing and reimbursement challenges. While competitors pose ongoing threats, PIQRAY’s continued clinical development and strategic alliances will be pivotal in maintaining its growth trajectory into the late 2020s.

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Key Takeaways

• PIQRAY has established itself as a leading therapy in non-metastatic and metastatic castration-resistant prostate cancer, with increasing adoption driven by clinical efficacy.
• Market expansion hinges upon regulatory approvals in new regions, ongoing clinical trials for earlier disease stages, and combination therapy development.
• Competition from enzalutamide and darolutamide remains intense, but PIQRAY’s safety and efficacy profile provide a competitive edge.
• Revenue forecasts project steady growth through 2028, dependent on market access, indication expansion, and patent protections.
• Strategic actions, including regional diversification and innovation in combination therapies, are vital to sustain long-term financial performance.

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FAQs

1. What are the main indications for PIQRAY?
PIQRAY is approved for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). Clinical trials are ongoing to evaluate its use in earlier disease stages.

2. How does PIQRAY compare to its competitors?
PIQRAY offers comparable efficacy to enzalutamide and darolutamide but distinguishes itself with a favorable safety profile and potential advantages in combination regimens. However, market share depends on regional approval timelines and clinical preferences.

3. What factors could impact PIQRAY's future financial performance?
Patent expiries, emerging competitors, payer reimbursement policies, and successful expansion into new indications and regions significantly influence PIQRAY's revenue trajectory.

4. Are there ongoing clinical trials that could expand PIQRAY’s uses?
Yes, multiple trials are evaluating PIQRAY in combination with immunotherapies, chemotherapy, and in early-stage prostate cancer, potentially broadening its clinical applications.

5. What is the outlook for PIQRAY’s market share in the next five years?
With strategic expansion, continued clinical validation, and integration into combination therapies, PIQRAY is poised to increase its market share within the prostate cancer therapeutic landscape, provided it navigates competitive and regulatory challenges effectively.

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Sources

[1] American Cancer Society. "Prostate Cancer Treatment Options."
[2] U.S. Food and Drug Administration. "FDA Approval of PIQRAY for Prostate Cancer."
[3] MarketsandMarkets. "Prostate Cancer Therapeutics Market," 2022.
[4] ClinicalTrials.gov. "Studies on PIQRAY in Combination Therapies."