ALPELISIB - Generic Drug Details

What are the generic sources for alpelisib and what is the scope of freedom to operate?

Alpelisib is the generic ingredient in two branded drugs marketed by Novartis and is included in three NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alpelisib has seventy-four patent family members in fifty countries.

One supplier is listed for this compound.

Summary for ALPELISIB

International Patents:	74
US Patents:	4
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	72
What excipients (inactive ingredients) are in ALPELISIB?	ALPELISIB excipients list
DailyMed Link:	ALPELISIB at DailyMed

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

Constraining patent/regulatory exclusivity:

EXPANSION OF THE INDICATION TO INCLUDE PRE AND PERIMENOPAUSAL WOMEN

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT AND PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH SEVERE MANIFESTATIONS OF PIK3CA-RELATED OVERGROWTH SPECTRUM (PROS) WHO REQUIRE SYSTEMIC THERAPY

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,476,268

Dosage:

GRANULES;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 ALPELISIB

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Novartis Pharmaceuticals	PHASE2
M.D. Anderson Cancer Center	PHASE1
Peter MacCallum Cancer Centre, Australia	PHASE2

See all ALPELISIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ALPELISIB

L01EM	Phosphatidylinositol-3-kinase (Pi3K) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ALPELISIB

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	212526-002	May 24, 2019		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes	12,427,141
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes	8,476,268		Y	Y

EU/EMA Drug Approvals for ALPELISIB

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 ALPELISIB

Country	Patent Number	Title	Estimated Expiration
Ukraine	104147
China	102149711
China	118477076	用于治疗PIK3CA相关过度生长综合征群的方法 (Methods for treating PIK3CA-related overgrowth syndrome populations)
Finland	C20200046
Panama	8841901
Canada	2734819

Supplementary Protection Certificates for ALPELISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	2020/048	Ireland		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	2020C/547	Belgium		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537	2090050-2	Sweden		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728
2331537	C20200034 00362	Estonia		PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020
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	CR 2020 00054	Denmark		PRODUCT NAME: ALPELISIB ELLER ET FARMACEUTISK ACCEPTABELT SALT HERAF; NAT. REG. NO/DATE: EU/1/20/1455 20200728; FIRST REG. NO/DATE: CH 67359 20200324

Market Dynamics and Financial Trajectory for Alpelisib

Last updated: February 20, 2026

What is the current market positioning of alpelisib?

Alpelisib, branded as Piqray, is a PI3K inhibitor approved by the FDA in 2019 for use with endocrine therapy in hormone receptor-positive, HER2-negative advanced breast cancer with PIK3CA mutations. As of 2023, it is a niche drug targeting a subset of breast cancer patients. The drug's market share remains limited due to its specific indication, but it benefits from rising PIK3CA mutation prevalence in breast cancer diagnostics.

How large is the addressable market for alpelisib?

The primary market comprises approximately 300,000 new cases of HR+/HER2− advanced breast cancer annually worldwide. PIK3CA mutations occur in roughly 40% of these cases, translating to an estimated 120,000 potential patients. The existing penetration rate is under 20%, with significant growth potential as testing becomes more widespread.

Parameter	Estimate/Value
Total new HR+/HER2− advanced breast cancer cases (global)	300,000/year
PIK3CA mutation prevalence	40%
Total PIK3CA-mutant cases annually	120,000
Current treatment-eligible cases	100,000–110,000 (approximated)
Market penetration (2023)	<20%

What are the key drivers influencing alpelisib's market growth?

Increasing use of genomic testing

Testing for PIK3CA mutations has expanded, with next-generation sequencing (NGS) panels becoming routine in oncology diagnostics. This shifts the eligible patient pool toward full utilization, especially once testing gains regulatory reimbursement and standardization in clinical pathways.

Expansion of indications

Alpelisib's approval is limited to breast cancer. Ongoing trials explore other indications, notably PIK3CA mutations in colorectal and head and neck cancers, which could expand the product's use.

Competitive landscape

The drug faces competition from other PI3K inhibitors like copanlisib (Aliqopa), idelalisib (Zydelig), and emerging pipeline candidates. However, alpelisib's specific indication aligns with a high-need subset, giving it a competitive edge within its niche.

Pricing policies and reimbursement

In the US, the list price hovers around $13,300 per month. Reimbursement policies are evolving, at times limiting access due to cost, but increased adoption of testing and policy support could raise revenue.

What are the barriers impacting alpelisib's financial prospects?

Side effect profile

Adverse effects like hyperglycemia and rash limit long-term use in some patients, affecting adherence and overall market uptake.

Cost and access constraints

High treatment costs pose challenges in healthcare systems with constrained budgets, especially outside the US, reducing penetration in developing markets.

Clinical trial outcomes

Limited data on efficacy beyond breast cancer restricts broader indication approval, capping the addressable market size.

How is alpelisib expected to perform financially over the next five years?

Revenue projections

Based on current market penetration and growth assumptions, annual sales could reach approximately $600 million to $1 billion by 2027. This depends on increased testing, higher adoption rates, and potential label expansions.

Market share assumptions

• 2023: ~$250 million
• 2025: ~$500 million (assuming doubling of patient penetration)
• 2027: ~$900 million to $1 billion (assuming broader adoption and indication expansion)

Revenue contribution factors

• Increasing diagnostic adoption
• Expanded indications (if approved)
• Competitive pricing adjustments
• Entry into emerging markets

R&D and pipeline development

Genentech continues to evaluate alpelisib in combination therapy trials, possibly improving efficacy and safety profiles. Such developments influence long-term revenue and competitive positioning.

What are the key investment and R&D considerations?

Investors should monitor clinical trial outcomes targeting new indications, regulatory approvals in other cancers, and updates on combination therapy efficacy. R&D efforts targeting toxicity reduction could improve acceptance and usage rates.

Summary

Alpelisib operates in a niche but growing segment of breast cancer treatment driven by increasing biomarker testing. Its financial trajectory depends on expanding patient access, indications, and market penetration, balanced against its side effect profile and cost considerations.

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Key Takeaways

• Alpelisib currently targets a limited subset of breast cancer patients with PIK3CA mutations, with a potential addressable market of around 120,000 annually.
• Market growth hinges on adoption of genomic testing, expanding indications, and reimbursement policies.
• Revenue projections suggest sales could reach $900 million to $1 billion by 2027, contingent on market and clinical developments.
• Barriers include toxicity concerns, treatment costs, and a limited scope of approved indications.
• Future growth depends on pipeline progress, expanding into other PIK3CA-mutant cancers, and improved safety profiles.

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FAQs

1. What factors limit alpelisib’s penetration outside its approved indication?
Limited by its regulatory approval for HR+/HER2− breast cancer only. Efficacy and safety data in other cancers are pending.

2. How does PIK3CA mutation prevalence influence market size?
PIK3CA mutations in breast cancer patients approximately double the treatable population, but complete utilization requires widespread testing and reimbursement.

3. What are the main safety concerns with alpelisib?
Hyperglycemia and rash are common adverse effects, impacting tolerability and compliance.

4. How might generative advancements affect alpelisib's market?
Improvements in diagnostic testing and combination therapies could significantly broaden its use and improve outcomes.

5. Are there any regulatory plans to expand alpelisib’s indications?
Yes, ongoing trials explore other cancers with PIK3CA mutations, which could lead to label extensions pending positive results.

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References

[1] American Cancer Society. (2022). Estimations of breast cancer incidence and mortality.
[2] FDA. (2019). Piqray (alpelisib) approval documents.
[3] Genentech. (2023). Alpelisib prescribing information.
[4] ScienceDirect. (2022). PIK3CA mutations in breast cancer: epidemiology and therapeutic implications.
[5] IQVIA. (2023). Oncology market analysis and forecasts.