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Alpelisib - Generic Drug Details

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

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

Alpelisib has fifty-five patent family members in forty-seven countries.

One supplier is listed for this compound.

Summary for alpelisib

International Patents:	55
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	30
Patent Applications:	1,995
What excipients (inactive ingredients) are in alpelisib?	alpelisib excipients list
DailyMed Link:	alpelisib at DailyMed

Recent Clinical Trials for alpelisib

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

Sponsor	Phase
Kura Oncology, Inc.	Phase 1/Phase 2
Saint Luke's Health System	Phase 2
Peter MacCallum Cancer Centre, Australia	N/A

See all alpelisib clinical trials

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	PIQRAY	alpelisib	TABLET;ORAL	212526-002	May 24, 2019		RX	Yes	No			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-002	May 24, 2019		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-003	May 24, 2019		RX	Yes	Yes			Y	Y
Novartis	PIQRAY	alpelisib	TABLET;ORAL	212526-001	May 24, 2019		RX	Yes	No			Y	Y

International Patents for alpelisib

Country	Patent Number	Estimated Expiration
Israel	210976
Eurasian Patent Organization	018863
South Korea	20110038737
Ukraine	104147
Croatia	P20160014
Hungary	S2000044
World Intellectual Property Organization (WIPO)	2010029082

Supplementary Protection Certificates for alpelisib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2331537	301071	Netherlands		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/20/1455 20200728
2331537	PA2020534	Lithuania		PRODUCT NAME: ALPELISIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1455 20200727
2331537	2020C/547	Belgium		PRODUCT NAME: ALPELISIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/20/1455 20200728
2331537	47/2020	Austria		PRODUCT NAME: ALPELISIB ODER SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1455 (MITTEILUNG) 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	132020000000155	Italy		PRODUCT NAME: ALPELISIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE.(PIQRAY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1455, 20200728
2331537	C02331537/01	Switzerland		PRODUCT NAME: ALPELISIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67359 24.03.2020