Alpelisib - Generic Drug Details

What are the generic drug 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 two NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Alpelisib has fifty-eight patent family members in forty-eight countries.

One supplier is listed for this compound.

Summary for alpelisib

International Patents:	58
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	63
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

Dosage:

TABLET;ORAL

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 alpelisib

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

Sponsor	Phase
University of Miami	Phase 2
Columbia University	Phase 1
Breast Cancer Research Foundation	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	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No			Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-003	Apr 5, 2022		RX	Yes	Yes

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
World Intellectual Property Organization (WIPO)	2010029082
Norway	2020037
Georgia, Republic of	P20135991	2-CARBOXAMIDE-PYRROLIDINE-AMIDE UREA DERIVATIVES SUBSTITUTED WITH PYRIMIDINE-4-YL, AND USAGE THEREAT TREATMENT OF DISEASES CAUSED BY PHOSPHATIDYL INOSITOL 3-KINASE

Supplementary Protection Certificates for alpelisib

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	2090050-2	Sweden		PRODUCT NAME: ALPELISIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. 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