Carfilzomib - Generic Drug Details

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, Breckenridge, Dr Reddys, and Onyx Therap, and is included in five 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-three patent family members in forty-one countries.

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

Summary for carfilzomib

International Patents:	223
US Patents:	11
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	210
Patent Applications:	7,755
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carfilzomib
What excipients (inactive ingredients) are in carfilzomib?	carfilzomib excipients list
DailyMed Link:	carfilzomib at DailyMed

Recent Clinical Trials for carfilzomib

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

Sponsor	Phase
Regeneron Pharmaceuticals	Phase 1
University of Colorado, Denver	Phase 2
OHSU Knight Cancer Institute	Phase 2

See all carfilzomib clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
		60MG/VIAL	POWDER;INTRAVENOUS
		10MG/VIAL	POWDER;INTRAVENOUS
		60MG/VIAL	POWDER;INTRAVENOUS

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

Anatomical Therapeutic Chemical (ATC) Classes for carfilzomib

L01XG	Proteasome inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CARFILZOMIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
KYPROLIS	For Injection	carfilzomib	10 mg/vial	202714	1	2018-11-28
KYPROLIS	For Injection	carfilzomib	30 mg/vial	202714	1	2017-10-05
KYPROLIS	For Injection	carfilzomib	60 mg/vial	202714	9	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	202714-003	Jun 7, 2018		RX	Yes	No			Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	No			Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012	AP	RX	Yes	Yes			Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	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			Y

EU/EMA Drug Approvals for carfilzomib

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe B.V.	Kyprolis	carfilzomib	EMEA/H/C/003790 Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.	Authorised	no	no	yes	2015-11-19

International Patents for carfilzomib

Country	Patent Number	Title	Estimated Expiration
Chile	2011000916	Uso de una combinacion de un inhibidor de proteasoma epoxicetona peptidica o una sal farmaceutica aceptable del mismo, y uno o mas de otros agentes terapeuticos para tratar el cancer.
Australia	2005313975	Composition for proteasome inhibition
Japan	2008509166
European Patent Office	3090737	THÉRAPIE DE COMBINAISON AVEC PEPTIDES D'ÉPOXYCÉTONES (COMBINATION THERAPY WITH PEPTIDE EPOXYKETONES)
Slovenia	1781688
Japan	6081964
Australia	2005243140	Synthesis of amino acid keto-epoxides

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	CR 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE HERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	93015	Luxembourg		PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123
1781688	1690013-6	Sweden		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
1781688	362 5009-2016	Slovakia		PRODUCT NAME: KARFILZOMIB; NAT. REGISTRATION NO/DATE: EU1/15/1060 20151123; FIRST REGISTRATION: EU EU/1/15/1060 20151123
1781688	CA 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
1781688	C01781688/01	Switzerland		PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: SWISSMEDIC 65690 23.11.2015