Orange Book product · Brand (NDA)

KYPROLIS

CARFILZOMIB

Brand (NDA)NDA 202714RX ONYX PHARMS AMGEN

Jun 03, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 03, 2016
10 yr 2 mo ago
Today
Patent 7417042 expires
Listed drug substance patent expiration.
Jul 20, 2026
in 1 mo
Patent 7417042*PED expires
Listed listed patent expiration.
Jan 20, 2027
in 7 mo
Patent 7737112 expires
Listed drug product patent expiration.
Dec 07, 2027
in 1 yr 6 mo
Exclusivity ends · M-14
New use / labeling-change exclusivity (3 years)
May 22, 2028
in 1 yr 11 mo
Patent 7737112*PED expires
Listed listed patent expiration.
Jun 07, 2028
in 2 yr
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Nov 22, 2028
in 2 yr 6 mo
Patent RE47954 expires
Listed method-of-use patent (U-3449) expiration.
Oct 21, 2029
in 3 yr 5 mo
Patent RE47954*PED expires
Listed listed patent expiration.
Apr 21, 2030
in 3 yr 11 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Patent 9493582*PED expires
Listed listed patent expiration.
Aug 27, 2033
in 7 yr 4 mo

Active ingredient

CARFILZOMIB

Strength

30MG/VIAL

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 202714

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7417042	Jul 20, 2026	in 1 mo	SubstanceProduct
7417042*PED	Jan 20, 2027	in 7 mo
7737112	Dec 07, 2027	in 1 yr 6 mo	Product
7737112*PED	Jun 07, 2028	in 2 yr
RE47954	Oct 21, 2029	in 3 yr 5 mo	U-3449
RE47954*PED	Apr 21, 2030	in 3 yr 11 mo
9493582	Feb 27, 2033	in 6 yr 10 mo	Product
9493582*PED	Aug 27, 2033	in 7 yr 4 mo