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 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:	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

Dosage:

TABLET;ORAL

Dosage:

TABLET;ORAL

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	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes			Y	Y
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-001	Apr 5, 2022		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes
Novartis	VIJOICE	alpelisib	TABLET;ORAL	215039-002	Apr 5, 2022		RX	Yes	No			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No			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/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
Cyprus	1117078
Cyprus	2020037
Jordan	3121	مشتقات 1 - ((5-هيتيرورلثيازول-2-يل) أمينوكاربونيل) بيروليدين-2-كربوكساميد كمثبات الفوسفاتديلينوسيتول 3-كيناس (PI3K) مفيدة في علاج الأمراض التصاعدية (1-((5-HETEROARYLTHIAZOL-2-YL)AMINOCARBONYL)PYRROLIDINE-2-CARBOXAMIDE DERIVATIVES AS PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) INHIBITORS USEFUL IN THE TREATMENT OF PROLIFERATIVE DISEASES)
Peru	20110796	(S)-1-({4-METIL-5-[2-(2,2,2-TRIFLUORO-1,1-DIMETIL-ETIL)-PIRIDIN-4-IL]-TIAZOL-2-IL}-AMIDA) DE 2-AMIDA DEL ACIDO PIRROLIDIN-1,2-DICARBOXILICO COMO INHIBIDOR DE LA CINASA DE FOSFATIDILINOSITOL (PI3K)
Colombia	6351738	COMPUESTOS ORGANICOS
Israel	210976	(s)-פירולידין-2,1-דיקרבוקסיליק אסיד 2-אמיד 1-({4-מתיל-5-[2-(2,2,2-טריפלואורו-1,1-דימתיל-אתיל)-פירידין-4-יל-]-תיאזול-2-יל}-אמיד), תכשירים רוקחיים המכילים אותו ושימושם לטיפול בסרטן ((s)-pyrrolidine-1,2-dicarboxylic acid 2-amide 1-({4-methyl-5-[2-(2,2,2-trifluoro-1,1-dimethyl-ethyl)-pyridin-4-yl]-thiazol-2-yl}-amide) and pharmaceutical compositions comprising same for use in treating cancer)

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	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	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	20C1055	France		EPRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	LUC00186	Luxembourg		PRODUCT NAME: ALPELISIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; 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