FDA Orange Book · active-ingredient family
Selenious acid
Selenious acid is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SELENIOUS ACID · NDA 209379
1
Brand (NDA)
7
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SELENIOUS ACIDRLD×3 | AM REGENT | NDA 209379 | AP | Aug 30, 2021 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SELENIOUS ACID | KINDOS | ANDA 219472 | AP | Feb 03, 2026 | |
| SELENIOUS ACID×2 | STIRA | ANDA 218536 | AP | Dec 31, 2025 | |
| SELENIOUS ACID×2 | CIPLA | ANDA 218661 | — | Jul 21, 2025 | |
| SELENIOUS ACID | GLAND | ANDA 219629 | AP | Jul 08, 2025 | |
| SELENIOUS ACID×2 | ASPIRO | ANDA 219633 | AP | Jun 11, 2025 | |
| SELENIOUS ACID | SUN PHARM | ANDA 219547 | AP | Feb 20, 2025 | |
| SELENIOUS ACID | FRESENIUS KABI USA | ANDA 218779 | — | Feb 10, 2025 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12150957 | Jul 01, 2041 | in 15 yr 3 mo | U-4039 |
| 11998565 | Jul 01, 2041 | in 15 yr 3 mo | Product |
Selenious acid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
