Orange Book product · Brand (NDA)

SOTYLIZE

SOTALOL HYDROCHLORIDE

Brand (NDA)NDA 205108RX AZURITY

Oct 22, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 22, 2014
11 yr 10 mo ago
Today
Patent 10206895 expires
Listed drug product patent expiration.
Apr 01, 2034
in 7 yr 11 mo
Patent 10206895 expires
Listed drug product patent expiration.
Apr 01, 2034
in 7 yr 11 mo
Patent 11013703 expires
Listed drug product patent expiration.
Apr 01, 2034
in 7 yr 11 mo
Patent 12290495 expires
Listed method-of-use patent (U-2096) expiration.
Apr 01, 2034
in 7 yr 11 mo
Patent 12290495 expires
Listed method-of-use patent (U-2494) expiration.
Apr 01, 2034
in 7 yr 11 mo
Patent 11850222 expires
Listed method-of-use patent (U-2096) expiration.
Nov 19, 2034
in 8 yr 7 mo
Patent 11850222 expires
Listed method-of-use patent (U-2494) expiration.
Nov 19, 2034
in 8 yr 7 mo
Patent 9724297 expires
Listed drug product patent expiration.
Aug 31, 2035
in 9 yr 4 mo

Active ingredient

SOTALOL HYDROCHLORIDE

Strength

5MG/ML (5MG/ML)

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 205108

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
10206895	Apr 01, 2034	in 7 yr 11 mo	ProductU-2096
10206895	Apr 01, 2034	in 7 yr 11 mo	ProductU-2494
11013703	Apr 01, 2034	in 7 yr 11 mo	Product
12290495	Apr 01, 2034	in 7 yr 11 mo	U-2096
12290495	Apr 01, 2034	in 7 yr 11 mo	U-2494
11850222	Nov 19, 2034	in 8 yr 7 mo	U-2096
11850222	Nov 19, 2034	in 8 yr 7 mo	U-2494
9724297	Aug 31, 2035	in 9 yr 4 mo	ProductU-2096