Orange Book product · Brand (NDA)
SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE
At a glance
Jul 02, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 02, 2009
17 yr 3 mo ago
Today
Patent 12403109 expires
Listed method-of-use patent (U-2769) expiration.
Aug 14, 2028
in 2 yr 2 mo
Patent 10512620 expires
Listed method-of-use patent (U-2769) expiration.
Aug 14, 2038
in 12 yr 4 mo
Patent 10512620 expires
Listed method-of-use patent (U-3547) expiration.
Aug 14, 2038
in 12 yr 4 mo
Patent 11696902 expires
Listed method-of-use patent (U-2769) expiration.
Aug 14, 2038
in 12 yr 4 mo
Patent 12390431 expires
Listed method-of-use patent (U-2769) expiration.
Aug 14, 2038
in 12 yr 4 mo
Patent 10799138 expires
Listed method-of-use patent (U-3549) expiration.
Apr 05, 2039
in 13 yr
Patent 10799138 expires
Listed method-of-use patent (U-3125) expiration.
Apr 05, 2039
in 13 yr
Patent 12569183 expires
Listed method-of-use patent (U-4456) expiration.
Apr 05, 2039
in 13 yr
Patent 11583216 expires
Listed method-of-use patent (U-3549) expiration.
Aug 21, 2039
in 13 yr 4 mo
Pharmaceutical detail
Active ingredient
SOTALOL HYDROCHLORIDE
Strength
150MG/10ML (15MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022306
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2014SOTYLIZEBrand (NDA)
NDA 205108 · AZURITY
- 2003BETAPACE AFBrand (NDA)
NDA 021151 · LEGACY PHARMA
- 1992BETAPACEBrand (NDA)
NDA 019865 · LEGACY PHARMA
- 2018SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207429 · REGCON HOLDINGS
- 2016SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 207428 · REGCON HOLDINGS
- 2007SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 077616 · AUROBINDO PHARMA USA
- 2005SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 077070 · EPIC PHARMA LLC
- 2004SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076883 · TEVA
- 2004SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076576 · SUN PHARM INDUSTRIES
- 2003SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 075563 · OXFORD PHARMS
- 2003SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076214 · APOTEX
- 2002SOTALOL HYDROCHLORIDEGeneric (ANDA)
ANDA 076140 · APOTEX
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403109 | Aug 14, 2028 | in 2 yr 2 mo | U-2769 |
| 10512620 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 10512620 | Aug 14, 2038 | in 12 yr 4 mo | U-3547 |
| 11696902 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 12390431 | Aug 14, 2038 | in 12 yr 4 mo | U-2769 |
| 10799138 | Apr 05, 2039 | in 13 yr | U-3549 |
| 10799138 | Apr 05, 2039 | in 13 yr | U-3125 |
| 12569183 | Apr 05, 2039 | in 13 yr | U-4456 |
| 11583216 | Aug 21, 2039 | in 13 yr 4 mo | U-3549 |
