Alpelisib - Generic Drug Details

What are the generic sources for alpelisib and what is the scope of patent protection?

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

Alpelisib has sixty patent family members in fifty countries.

One supplier is listed for this compound.

Summary for alpelisib

International Patents:	60
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	66
Patent Applications:	2,670
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	Phase 2/Phase 3
Dartmouth-Hitchcock Medical Center	Phase 2
University of Miami	Phase 2

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	215039-001	Apr 5, 2022		RX	Yes	No	8,227,462		Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	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	8,227,462		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	8,476,268		Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No

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/004804 Piqray 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
Hungary	E025884
Lithuania	PA2020534
San Marino	P201100019	Composti organici
Slovenia	2331537
Eurasian Patent Organization	018863	ОРГАНИЧЕСКИЕ СОЕДИНЕНИЯ (ORGANIC COMPOUNDS)
Ecuador	SP11010880	COMPUESTOS ORGÁNICOS
Luxembourg	C00186

Supplementary Protection Certificates for alpelisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	2090050-2	Sweden		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1455 20200728
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	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	SPC/GB20/059	United Kingdom		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 67359 20200324; UK EU/1/20/1455(FOR NI) 20200728; UK FURTHER MA ON IPSUM 20200728
2331537	2020/048	Ireland		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	PA2020534,C2331537	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727

Market Dynamics and Financial Trajectory of Alpelisib

Market Overview

Alpelisib, marketed as Piqray, is a phosphatidylinositol 3-kinase (PI3K) inhibitor used primarily in the treatment of advanced breast cancer, particularly in patients with PIK3CA mutations. The drug has shown significant promise in prolonging progression-free survival (PFS) and overall response rates in specific patient subgroups.

Market Growth and Projections

The Alpelisib market is anticipated to grow at a substantial compound annual growth rate (CAGR) from 2024 to 2034. This growth is driven by several factors, including the increasing incidence of breast cancer globally and the drug's efficacy in treating PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer[1][4].

Regional Market Analysis

North America

North America currently dominates the Alpelisib market, largely due to the high prevalence of breast cancer, extensive healthcare infrastructure, and favorable regulatory environment. The region is expected to continue its dominance, fueled by increasing FDA approvals and the rising number of breast cancer cases among American women[4].

Europe

In Europe, countries like Germany, France, and the UK are key markets for Alpelisib. Government programs and substantial healthcare expenditures in these countries support the market expansion. Personalized medications and precision medicine also contribute to the drug's market share in this region[1].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing segment during the forecast period. This growth is attributed to an extensive patient pool, increasing disposable income, and improved access to advanced healthcare facilities. Countries such as China and India are driving this growth due to rising cancer incidence rates and better healthcare infrastructure[1][4].

Middle East & Africa and South America

These regions are also expected to contribute to the market growth, albeit at a slower pace compared to North America and Asia Pacific. Factors such as increasing healthcare expenditures and growing awareness about advanced cancer treatments are driving the demand for Alpelisib in these regions[1][4].

Key Market Players

The Alpelisib market is dominated by a few large pharmaceutical companies, with Novartis AG being the primary player. Novartis's strong market presence and continuous research and development efforts are crucial in maintaining the drug's market share[1].

Distribution Channels

The Alpelisib market is segmented by distribution channels, including drug stores, mail order pharmacies, and online platforms. Each channel plays a significant role in making the drug accessible to a wide range of patients. Online platforms, in particular, are gaining traction due to their convenience and reach[1][4].

Clinical Efficacy and Safety

Alpelisib has demonstrated clinically meaningful and statistically significant results in breast cancer treatment. When combined with fulvestrant, it significantly prolongs PFS in patients with PIK3CA mutations. For instance, in the SOLAR-1 trial, the median PFS was 11.0 months for patients receiving the Alpelisib combination compared to 5.7 months for those receiving placebo plus fulvestrant[2].

However, the drug is associated with several adverse events, including hyperglycemia, diarrhea, nausea, and rash, which are consistent with previous findings of PI3K inhibitors[2].

Cost-Effectiveness

The cost-effectiveness of Alpelisib plus fulvestrant has been evaluated in various studies. For example, in Qatar, this combination was found to be a cost-effective strategy for treating HR+/HER2- advanced breast cancer patients, with a quality-adjusted life year (QALY) cost ranging from $62,088 to $186,264[5].

Market Drivers

• Increasing Cancer Incidence: The rising number of breast cancer cases globally is a significant driver for the Alpelisib market.
• Efficacy in Specific Subgroups: The drug's effectiveness in treating PIK3CA-mutant breast cancer patients enhances its market appeal.
• Regulatory Approvals: Recent approvals by regulatory bodies such as the FDA and Philippine FDA have expanded the drug's market reach.
• Healthcare Infrastructure: Improvements in healthcare facilities and increasing healthcare expenditures in various regions support market growth[1][4].

Market Restraints

• Side Effects: The drug's adverse event profile, including hyperglycemia and diarrhea, can be a deterrent for some patients.
• Cost: The high cost of Alpelisib and its combination therapies can limit access in some regions.
• Competition: While Alpelisib is a leading PI3K inhibitor, competition from other cancer therapies can impact its market share[2][4].

Financial Trajectory

The Alpelisib market is projected to reach significant revenue by 2034, driven by its growing adoption and expanding market reach. The market size was valued at USD XX million in 2021 and is expected to grow at a CAGR of XX% from 2022 to 2030[4].

Revenue Estimates

• Global Revenue: The global Alpelisib market revenue is estimated to increase substantially over the forecast period.
• Regional Revenue: North America is expected to maintain its leading position, followed by Asia Pacific, which is anticipated to be the fastest-growing region[1][4].

Key Takeaways

• Alpelisib is a critical treatment option for PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer.
• The drug's market is driven by increasing cancer incidence, regulatory approvals, and improving healthcare infrastructure.
• North America and Asia Pacific are key regions driving market growth.
• The drug's efficacy and safety profile are crucial for its continued market success.
• Cost-effectiveness studies support the drug's value in treating specific patient subgroups.

FAQs

What is Alpelisib used for?

Alpelisib is used to treat advanced breast cancer, particularly in patients with PIK3CA mutations. It is often combined with fulvestrant for postmenopausal women and men with HR-positive, HER2-negative breast cancer[2][4].

Which regions are driving the growth of the Alpelisib market?

North America and Asia Pacific are the primary regions driving the growth of the Alpelisib market. North America dominates due to high prevalence and favorable regulatory environment, while Asia Pacific is growing rapidly due to increasing healthcare infrastructure and rising cancer incidence[1][4].

What are the common side effects of Alpelisib?

Common side effects of Alpelisib include hyperglycemia, diarrhea, nausea, rash, vomiting, decreased appetite, and fatigue. These adverse events are consistent with the profile of PI3K inhibitors[2].

Is Alpelisib cost-effective?

Alpelisib plus fulvestrant has been found to be a cost-effective strategy in treating HR+/HER2- advanced breast cancer patients, with a QALY cost ranging from $62,088 to $186,264 in some studies[5].

Which company is the primary player in the Alpelisib market?

Novartis AG is the primary player in the Alpelisib market, driving the drug's development, marketing, and distribution[1].

Sources:

1. We Market Research - Alpelisib Market Research Report 2024-2034
2. Onclive - Addition of Alpelisib Prolongs PFS in PIK3CA-Mutant HR+, HER2- Advanced Breast Cancer Subgroups
3. Canadian Journal of Health Technologies - View of Alpelisib (Piqray)
4. Nextmsc - Alpelisib Market Size and Share | Statistics - 2030
5. ISPOR - Cost-Effectiveness of Alpelisib Plus Fulvestrant in Postmenopausal Women with HR+/HER2- Advanced Breast Cancer