Onyx Therap Company Profile

What is the competitive landscape for ONYX THERAP, and when can generic versions of ONYX THERAP drugs launch?

ONYX THERAP has one approved drug.

There are eleven US patents protecting ONYX THERAP drugs.

There are one hundred and ninety-four patent family members on ONYX THERAP drugs in forty-one countries and eighteen supplementary protection certificates in sixteen countries.

Summary for Onyx Therap

International Patents:	194
US Patents:	11
Tradenames:	1
Ingredients:	1
NDAs:	1
Patent Litigation for Onyx Therap:	See patent lawsuits for Onyx Therap

Drugs and US Patents for Onyx Therap

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	7,737,112		Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-002	Jun 3, 2016		RX	Yes	No	8,207,297		Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	No	8,207,126		Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-003	Jun 7, 2018		RX	Yes	No	8,207,127
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	8,207,297		Y	Y

Paragraph IV (Patent) Challenges for ONYX THERAP drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	For Injection	10 mg/vial		2018-11-28
	For Injection	60 mg/vial		2016-07-20

International Patents for Onyx Therap Drugs

Country	Patent Number	Estimated Expiration
Brazil	PI0509879
Hungary	E027850
Australia	2005271232
Australia	2005313975
South Korea	101354280
Cyprus	1116771

Supplementary Protection Certificates for Onyx Therap Drugs

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	16C0017	France		PRODUCT NAME: CARFILZOMIB; REGISTRATION NO/DATE: EU/1/15/1060 20151123
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	CA 2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; 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	PA2016010	Lithuania		PRODUCT NAME: KARFILZOMIBAS; REGISTRATION NO/DATE: EU/1/15/1060 20151119

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Onyx Therap