Orange Book product · Brand (NDA)

CARNEXIV

CARBAMAZEPINE

Brand (NDA)NDA 206030DISCN LUNDBECK PHARMS LLC

Oct 07, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 07, 2016
9 yr 10 mo ago
Today
Patent 9629797 expires
Listed method-of-use patent (U-2004) expiration.
Nov 10, 2028
in 2 yr 5 mo
Patent 9629797 expires
Listed method-of-use patent (U-2005) expiration.
Nov 10, 2028
in 2 yr 5 mo
Patent 9629797 expires
Listed method-of-use patent (U-2006) expiration.
Nov 10, 2028
in 2 yr 5 mo
Patent 9770407 expires
Listed drug product patent expiration.
Nov 10, 2028
in 2 yr 5 mo
Patent 7635773 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 8410077 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9750822 expires
Listed drug product patent expiration.
Mar 13, 2029
in 2 yr 9 mo
Patent 9493582 expires
Listed drug product patent expiration.
Feb 27, 2033
in 6 yr 10 mo
Patent 11529357 expires
Listed drug product patent expiration.
Jan 31, 2040
in 13 yr 10 mo

Active ingredient

CARBAMAZEPINE

Strength

200MG/20ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 206030

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
9629797	Nov 10, 2028	in 2 yr 5 mo	U-2004
9629797	Nov 10, 2028	in 2 yr 5 mo	U-2005
9629797	Nov 10, 2028	in 2 yr 5 mo	U-2006
9770407	Nov 10, 2028	in 2 yr 5 mo	Product
7635773	Mar 13, 2029	in 2 yr 9 mo	Product
8410077	Mar 13, 2029	in 2 yr 9 mo	Product
9750822	Mar 13, 2029	in 2 yr 9 mo	Product
9493582	Feb 27, 2033	in 6 yr 10 mo	Product
11529357	Jan 31, 2040	in 13 yr 10 mo	Product