FDA Orange Book · active-ingredient family
Torsemide
Torsemide is approved as 3 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SOAANZ · NDA 213218
3
Brand (NDA)
12
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SOAANZRLD×3 | SARFE PHARMS | NDA 213218 | — | Jun 14, 2021 | |
| DEMADEXRLD×2 | ROCHE | NDA 020137 | — | Aug 23, 1993 | |
| DEMADEXRLD×4 | PHARMOBEDIENT | NDA 020136 | — | Aug 23, 1993 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TORSEMIDE×3 | MICRO LABS | ANDA 217239 | AB | May 01, 2026 | |
| TORSEMIDE×4 | STRIDES PHARMA INTL | ANDA 090613 | AB | Mar 22, 2011 | |
| TORSEMIDE×2 | AM REGENT | ANDA 090656 | — | Apr 21, 2010 | |
| TORSEMIDE×4 | HETERO LABS LTD III | ANDA 079234 | AB | Jan 27, 2009 | |
| TORSEMIDE×2 | HIKMA | ANDA 078007 | — | Jun 11, 2008 | |
| TORSEMIDE×4 | SUN PHARM INDS | ANDA 078478 | — | Feb 26, 2008 | |
| TORSEMIDE×4 | AUROBINDO PHARMA | ANDA 078249 | AB | Oct 17, 2007 | |
| TORSEMIDE×4 | COREPHARMA | ANDA 076894 | AB | May 31, 2005 | |
| TORSEMIDE×3 | HIKMA | ANDA 076943 | — | Mar 01, 2005 | |
| TORSEMIDE×4 | PLIVA PHARM IND | ANDA 076346 | AB | May 30, 2003 | |
| TORSEMIDE×4 | STRIDES PHARMA INTL | ANDA 076226 | AB | May 27, 2003 | |
| TORSEMIDE×4 | TEVA | ANDA 076110 | — | May 14, 2002 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10154963 | Oct 06, 2033 | in 7 yr 5 mo | Product |
Torsemide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
