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Onyx Therap Company Profile

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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 seventy patent family members on ONYX THERAP drugs in thirty-six countries and nine supplementary protection certificates in eight countries.

Summary for Onyx Therap

International Patents:	170
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	202714-001	Jul 20, 2012		RX	Yes	Yes	7,232,818		Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes	8,207,297		Y	Y
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes
Onyx Therap	KYPROLIS	carfilzomib	POWDER;INTRAVENOUS	202714-001	Jul 20, 2012		RX	Yes	Yes	8,207,125		Y	Y

Paragraph IV (Patent) Challenges for ONYX THERAP drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	For Injection	60 mg/vial		2016-07-20

Non-Orange Book US Patents for Onyx Therap

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,324,174	Compounds for enzyme inhibition
8,198,270	Compounds for proteasome enzyme inhibition
8,207,124	Compounds for enzyme inhibition
8,088,741	Compounds for enzyme inhibition

International Patents for Onyx Therap Drugs

Country	Document Number	Estimated Expiration
China	104704007
Japan	2012121895
Japan	5675629
European Patent Office	2030981

Supplementary Protection Certificates for Onyx Therap Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016 00014	Denmark		PRODUCT NAME: CARFILZOMIB OG FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1060 20151123
16/013	Ireland		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/15/1060 20151119
90013-6	Sweden		PRODUCT NAME: CARFILZOMIB OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/15/1060 20151123
015	Luxembourg		PRODUCT NAME: CARFILZOMIB EVENTUELLEMENT SOUS FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE; FIRST REGISTRATION: 20151123

Similar Applicant Names

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

• Onyx Therap