CARFILZOMIB - Generic Drug Details

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What are the generic 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 Pharms Amgen, 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 patent family members in forty-two countries.

There are ten drug master file entries for carfilzomib. One supplier is listed for this compound. There are four tentative approvals for this compound.

Summary for CARFILZOMIB

International Patents:	220
US Patents:	11
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	228
Patent Applications:	6,016
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
AbbVie	Phase 3
Pfizer	Phase 3
Hoffmann-La Roche	Phase 1/Phase 2

See all CARFILZOMIB clinical trials

Generic filers with tentative approvals for CARFILZOMIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	60MG/VIAL	POWDER;INTRAVENOUS
⤷ Sign Up	⤷ Sign Up	10MG/VIAL	POWDER;INTRAVENOUS
⤷ Sign Up	⤷ Sign Up	60MG	INJECTABLE;INJECTION

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

Pharmacology for CARFILZOMIB

Drug Class	Proteasome Inhibitor
Mechanism of Action	Proteasome Inhibitors

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

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Glossary

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

EU/EMA Drug Approvals for CARFILZOMIB

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for CARFILZOMIB

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Country	Patent Number	Title	Estimated Expiration
China	104704007	Alkylated cyclodextrin compositions and processes for preparing and using the same	⤷ Sign Up
Australia	2018256546	Combination therapy with peptide epoxyketones	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006017842		⤷ Sign Up
Denmark	1781688		⤷ Sign Up
Germany	602005026556		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CARFILZOMIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1781688	C 2016 014	Romania	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: CARFILZOMIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES DAVON; REGISTRATION NO/DATE: EU/1/15/1060 (MITTEILUNG) 20151123
1781688	1690013-6	Sweden	⤷ Sign Up	PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
1781688	625	Finland	⤷ Sign Up
1781688	PA2016010	Lithuania	⤷ Sign Up	PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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