FDA Orange Book · active-ingredient family
Sotalol hydrochloride
Sotalol hydrochloride is approved as 4 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOTYLIZE · NDA 205108
4
Brand (NDA)
17
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOTYLIZERLD | AZURITY | NDA 205108 | — | Oct 22, 2014 | |
| SOTALOL HYDROCHLORIDERLD | ALTATHERA PHARMS LLC | NDA 022306 | — | Jul 02, 2009 | |
| BETAPACE AFRLD×6 | LEGACY PHARMA | NDA 021151 | AB | Feb 22, 2000 | |
| BETAPACERLD×5 | LEGACY PHARMA | NDA 019865 | AB | Oct 30, 1992 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOTALOL HYDROCHLORIDE×3 | REGCON HOLDINGS | ANDA 207429 | AB | Nov 02, 2018 | |
| SOTALOL HYDROCHLORIDE×3 | REGCON HOLDINGS | ANDA 207428 | AB | Oct 21, 2016 | |
| SOTALOL HYDROCHLORIDE×3 | AUROBINDO PHARMA USA | ANDA 077616 | AB | Feb 07, 2007 | |
| SOTALOL HYDROCHLORIDE×3 | EPIC PHARMA LLC | ANDA 077070 | AB | Nov 04, 2005 | |
| SOTALOL HYDROCHLORIDE×3 | TEVA | ANDA 076883 | — | Jul 26, 2004 | |
| SOTALOL HYDROCHLORIDE×3 | SUN PHARM INDUSTRIES | ANDA 076576 | — | Apr 08, 2004 | |
| SOTALOL HYDROCHLORIDE×4 | OXFORD PHARMS | ANDA 075563 | AB | Nov 07, 2003 | |
| SOTALOL HYDROCHLORIDE×3 | APOTEX | ANDA 076214 | AB | Aug 27, 2003 | |
| SOTALOL HYDROCHLORIDE×4 | APOTEX | ANDA 076140 | AB | Sep 26, 2002 | |
| SOTALOL HYDROCHLORIDE×4 | SUN PHARM INDUSTRIES | ANDA 075515 | — | Oct 15, 2001 | |
| SORINE×4 | AIPING PHARM INC | ANDA 075500 | AB | Apr 27, 2001 | |
| SOTALOL HYDROCHLORIDE×4 | RISING | ANDA 075725 | — | Dec 19, 2000 | |
| SOTALOL HYDROCHLORIDE×4 | IMPAX PHARMS | ANDA 075663 | — | Nov 07, 2000 | |
| SOTALOL HYDROCHLORIDE×4 | WATSON LABS | ANDA 075238 | — | Jul 13, 2000 | |
| SOTALOL HYDROCHLORIDE×4 | NOVITIUM PHARMA | ANDA 075237 | — | May 01, 2000 | |
| SOTALOL HYDROCHLORIDE×4 | TEVA | ANDA 075429 | AB | May 01, 2000 | |
| SOTALOL HYDROCHLORIDE×4 | UPSHER SMITH LABS | ANDA 075366 | — | May 01, 2000 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403109 | Aug 14, 2028 | in 2 yr 2 mo | U-2769 |
| 10206895 | Apr 01, 2034 | in 7 yr 11 mo | ProductU-2096 |
| 12290495 | Apr 01, 2034 | in 7 yr 11 mo | U-2096 |
| 11013703 | Apr 01, 2034 | in 7 yr 11 mo | Product |
| 11850222 | Nov 19, 2034 | in 8 yr 7 mo | U-2096 |
| 9724297 | Aug 31, 2035 | in 9 yr 4 mo | ProductU-2096 |
| 10512620 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 12390431 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 11696902 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 10799138 | Apr 05, 2039 | in 13 yr | U-3549 |
| 12569183 | Apr 05, 2039 | in 13 yr | U-4456 |
| 11583216 | Aug 21, 2039 | in 13 yr 4 mo | U-3549 |
Sotalol hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
