Orange Book product · Brand (NDA)

NUVESSA

METRONIDAZOLE

Brand (NDA)NDA 205223RX ALEMBIC THERAP

Mar 24, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Mar 24, 2014
12 yr 5 mo ago
Today
Patent 8877792 expires
Listed drug product patent expiration.
Feb 02, 2028
in 1 yr 8 mo
Patent 7893097 expires
Listed drug product patent expiration.
Feb 19, 2028
in 1 yr 8 mo
Patent 8658678 expires
Listed method-of-use patent (U-1682) expiration.
Jun 27, 2028
in 2 yr 1 mo
Patent 10238634 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 10596155 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 8946276 expires
Listed method-of-use patent (U-1664) expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9198858 expires
Listed method-of-use patent (U-1664) expiration.
Jun 28, 2032
in 6 yr 1 mo

Active ingredient

METRONIDAZOLE

Strength

1.3%

Dosage form

GEL

Route

VAGINAL

TE code

Not listed

Application

NDA 205223

Product number

001

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
8877792	Feb 02, 2028	in 1 yr 8 mo	Product
7893097	Feb 19, 2028	in 1 yr 8 mo	Product
8658678	Jun 27, 2028	in 2 yr 1 mo	U-1682
10238634	Jun 28, 2032	in 6 yr 1 mo	Product
10596155	Jun 28, 2032	in 6 yr 1 mo	Product
8946276	Jun 28, 2032	in 6 yr 1 mo	U-1664
9198858	Jun 28, 2032	in 6 yr 1 mo	U-1664