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Carfilzomib - Generic Drug Details

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What are the generic drug sources for carfilzomib and what is the scope of freedom to operate?

Carfilzomib is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, and Onyx Therap, and is included in four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Carfilzomib has two hundred and twenty-one patent family members in forty-one countries.

There are ten drug master file entries for carfilzomib. There are two tentative approvals for this compound.

Summary for carfilzomib

International Patents:	221
US Patents:	11
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	10
Bulk Api Vendors:	67
Clinical Trials:	187
Patent Applications:	2,991
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carfilzomib
DailyMed Link:	carfilzomib at DailyMed

Recent Clinical Trials for carfilzomib

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

Sponsor	Phase
Sorlandet Hospital HF	Phase 2/Phase 3
Førde Central Hospital	Phase 2/Phase 3
The Hospital of Vestfold	Phase 2/Phase 3

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		60MG/VIAL	POWDER;INTRAVENOUS
		UNKNOWN	UNKNOWN

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Paragraph IV (Patent) Challenges for CARFILZOMIB

Tradename	Dosage	Ingredient	NDA	Submissiondate
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2018-11-28
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2017-10-05
KYPROLIS	POWDER;INTRAVENOUS	carfilzomib	202714	2016-07-20

US Patents and Regulatory Information for carfilzomib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No			Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes

International Patents for carfilzomib

Country	Patent Number	Estimated Expiration
Poland	1819353
Japan	2012041346
Singapore	185306
Slovenia	1781688
European Patent Office	2260835
European Patent Office	1745064
European Patent Office	2349313

Supplementary Protection Certificates for carfilzomib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	C 2016 014	Romania		PRODUCT NAME: CARFILZOMIB; NATIONAL AUTHORISATION NUMBER: EU/1/15/1060; DATE OF NATIONAL AUTHORISATION: 20151119; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1060; DATE OF FIRST AUTHORISATION IN EEA: 20151119
1781688	12/2016	Austria		PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
1781688	CA 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	300805	Netherlands		PRODUCT NAME: CARFILZOMIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/15/1060 20151123
1781688	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
1781688	132016000047656	Italy		PRODUCT NAME: CARFILZOMIB OPZIONALMENTE IN FORMA DI UN SALE FARMACEUTICAMENTE ACCETTABILE(KYPROLIS); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1060, 20151123
1781688	PA2016010,C1781688	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119