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 three 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:	3
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:

8,227,462

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,227,462

Dosage:

TABLET;ORAL

Constraining patent/regulatory exclusivity:

8,227,462

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
Royal Children's Hospital	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	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes	8,227,462		Y	Y
Novartis	VIJOICE	alpelisib	GRANULES;ORAL	218466-001	Apr 24, 2024		RX	Yes	Yes	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No	8,227,462		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No	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
European Patent Office	2331537
Denmark	2331537
Argentina	112074
Morocco	32604
South Africa	201100699
Poland	2331537

Supplementary Protection Certificates for ALPELISIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2331537	2020/048	Ireland		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; 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	C20200034 00362	Estonia		PRODUCT NAME: ALPELISIIB;REG NO/DATE: EU/1/20/1455 28.07.2020
2331537	2020037	Norway		PRODUCT NAME: ALPELISIB ELLER ET FARMASOEYTISK AKSEPTABELT SALT DERAV; REG. NO/DATE: EU/1/20/1455 20200810

Market Dynamics and Financial Trajectory for Alpelisib

Last updated: July 27, 2025

Introduction

Alpelisib, marketed under the brand name Piqray, represents a significant advancement in personalized oncology therapy, specifically targeting hormone receptor-positive, HER2-negative, PIK3CA-mutated advanced breast cancer. Developed by Novartis, alpelisib’s market performance hinges on evolving clinical data, regulatory landscape, competitive positioning, and broader healthcare trends. A comprehensive analysis of its market dynamics and financial trajectory offers vital insights for stakeholders, investors, and healthcare providers.

Pharmacological Profile and Therapeutic Indications

Alpelisib is an oral, selective phosphatidylinositol-3-kinase (PI3K) alpha-specific inhibitor. The PI3K/AKT/mTOR pathway plays a pivotal role in cell growth, proliferation, and survival, and its dysregulation has been implicated in various cancers, notably breast cancer with PIK3CA mutations. Approval by the U.S. Food and Drug Administration (FDA) in 2019 marked a milestone for precision oncology. Its primary indication is for postmenopausal women and adults with HR-positive, HER2-negative advanced or metastatic breast cancer harboring PIK3CA mutations, in combination with fulvestrant.

Market Dynamics

1. Clinical Validation and Regulatory Milestones

The approval of alpelisib was anchored in the SOLAR-1 trial, which demonstrated a significant improvement in progression-free survival (PFS) when combined with fulvestrant, compared to fulvestrant alone. The trial's success validated a targeted approach that leverages genetic testing for PIK3CA mutations, aligning with the broader shift toward personalized treatment paradigms.

Subsequent regulatory statuses bolster its market potential: apart from the FDA, alpelisib has received approval in Europe (EMA) and other jurisdictions, albeit with varying indications and label specifics. The approval for first-line use remains pending, contingent upon ongoing trials such as SOLAR-2, which could broaden its application scope.

2. Competitive Landscape

Alpelisib faces competition from both emerging PI3K inhibitors and broader breast cancer therapies. Notable competitors include:

• Taselisib (Genentech/Roche): Though previously in development, its clinical trajectory has faced setbacks.
• Buparlisib (BKM120): Clinical trials failed to demonstrate sufficient efficacy and safety.
• GDC-0077 (XG-102): An emerging PI3K inhibitor with potential future impact.
• Traditional therapies like CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) remain concomitantly used, indirectly influencing alpelisib’s market share.

The niche of PIK3CA mutation-specific therapy positions alpelisib favorably, especially with increased adoption of comprehensive genomic testing.

3. Diagnostic and Testing Integrations

Alpelisib's success is tightly coupled with genetic testing for PIK3CA mutations. The proliferation of next-generation sequencing (NGS) panels and companion diagnostics enhances patient stratification, elevating treatment precision. Key partnerships with diagnostic firms and proactive clinical guideline endorsements (e.g., NCCN guidelines) underpin this integrated approach, broadening access.

4. Market Penetration and Adoption Drivers

Factors influencing adoption include:

• Clinical efficacy: The demonstrated PFS benefit drives physician acceptance.
• Safety profile: Managing adverse effects, particularly hyperglycemia and rash, influences prescription patterns.
• Reimbursement policies: Coverage decisions by payers impact market penetration; positive health economic evaluations support favorable reimbursement.
• Clinical guidelines: Endorsement by NCCN and ASCO accelerates uptake.

5. Broader Oncology Trends

The shift toward molecularly targeted therapies creates a favorable environment. The increasing prevalence of PIK3CA mutations (estimated at 40% of HR-positive breast cancers) sustains a substantial patient base. Growing awareness and routine testing further facilitate market expansion.

Financial Trajectory

1. Revenue Generation and Market Share

Since its 2019 approval, alpelisib has demonstrated steady revenue growth. Novartis reported global sales of approximately $250 million in 2022, reflecting its initial market penetration. The drug's sales are projected to escalate, contingent upon several factors:

• Expansion into earlier lines of therapy: Pending trial outcomes could lead to broader label indications.
• Geographic expansion: Increasing approvals in emerging markets, especially in Asia-Pacific, where targeted therapies gain traction.
• Increased testing rates: More comprehensive testing increases eligible patient populations.

2. Pricing Strategy and Cost-Effectiveness

Alpelisib is priced premium, with U.S. wholesale acquisition costs (WAC) exceeding $13,000/month. Cost-effectiveness analyses support its value based on PFS improvements; however, high costs pose reimbursement challenges, especially in cost-sensitive healthcare systems. Negotiated discounts and value-based pricing models are emerging strategies to improve access.

3. Growth Drivers and inhibitors

• Drivers: The expanding PIK3CA-mutation testing, supportive clinical data, and increasing awareness.
• Inhibitors: Safety concerns, competition from other targeted therapies, and the potential for biosimilar or generic entrants post-patent expiry (expected around 2034, given a 12-year exclusivity window).

4. Pipeline and Future Opportunities

Ongoing clinical trials aim to validate alpelisib's efficacy in other PIK3CA-driven cancers like head and neck squamous cell carcinoma and endometrial cancer, potentially diversifying its revenue base. Combination regimens with immune checkpoint inhibitors are also under evaluation.

Challenges and Opportunities

Challenges

• Safety profile management: Significant adverse events necessitate vigilant patient monitoring.
• Limited indication scope: Currently restricted to PIK3CA-mutated HR-positive breast cancer.
• High drug cost: Limits accessibility and payor reimbursement.
• Competitive developments: Emergence of novel PI3K inhibitors with improved tolerability.

Opportunities

• Biomarker-driven expansion: Broader use in other PIK3CA-mutant tumors.
• Combination therapies: Synergies with immunotherapies and other targeted agents.
• Global market penetration: Particularly in regions with increasing genomic testing infrastructure.
• Cost management strategies: Value-based pricing and patient assistance programs.

Regulatory and Reimbursement Outlook

Regulatory agencies are likely to approve label expansion contingent upon ongoing trial data. Reimbursement prospects will improve with demonstrated cost-effectiveness and clinical benefit, especially in healthcare systems emphasizing personalized medicine.

Conclusion

Alpelisib boasts a compelling position within targeted breast cancer therapy, driven by robust clinical validation and an increasingly favorable diagnostic landscape. Its financial trajectory is promising but remains susceptible to safety concerns, competitive forces, and cost considerations. Strategic advancements in indication expansion, combination therapies, and cost management will be critical to maximizing market potential.

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Key Takeaways

• Market Position: Alpelisib has solidified its role as the first selective PI3K alpha inhibitor approved for PIK3CA-mutant HR-positive breast cancer, with ongoing trials poised to expand its application.
• Drivers & Barriers: Clinical efficacy, genetic testing integration, and reimbursement policies are key growth drivers; safety profile and high costs challenge broader adoption.
• Financial Outlook: Revenue growth will depend on indication expansion, competitive landscape, and pricing strategies; global market expansion presents significant opportunities.
• Strategic Focus: Enhancing safety management, pursuing pipeline opportunities, and fostering partnerships with diagnostic providers are essential for sustaining growth.
• Future Outlook: The evolving oncology landscape and increasing focus on personalized medicine position alpelisib favorably, provided it adapts to clinical and market challenges.

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FAQs

1. What are the primary indications for alpelisib?
Alpelisib is indicated for postmenopausal women and adults with HR-positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, used in combination with fulvestrant.

2. How does alpelisib compare to other PI3K inhibitors?
Alpelisib’s selectivity for the PI3K alpha isoform provides a distinct safety profile and efficacy advantage in PIK3CA-mutant tumors, distinguishing it from less selective inhibitors like Buparlisib, which faced safety limitations.

3. What challenges might affect alpelisib's market growth?
Safety concerns, high treatment costs, limited indication scope, and stiff competition from emerging therapies may impede its broader adoption.

4. Are there ongoing trials to expand alpelisib’s use?
Yes; trials such as SOLAR-2 aim to evaluate its efficacy in other PIK3CA-mutant cancers, which could lead to label expansions and market growth.

5. How does the cost of alpelisib influence its reimbursement?
Its high monthly price creates reimbursement challenges, but health economic models and value-based pricing are being explored to improve patient access.

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Sources

1. U.S. Food and Drug Administration. Piqray (Alpelisib) Prescribing Information. 2019.
2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer. 2022.
3. Novartis AG. Annual Report 2022.
4. ClinicalTrials.gov. Ongoing clinical trials involving alpelisib.
5. IQVIA. Pharmaceutical Market Trends, 2022.