FDA Orange Book · active-ingredient family
Selenious acid
Selenious acid: 1 brand, 8 generics; first approved Apr 30, 2019; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 8 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
8
Listed patents
2
Next patent expiry
Jul 01, 2041
in 15 yr 2 mo
Brand (NDA) products
Originator applications
- SELENIOUS ACIDRLDRSAM REGENTNDA 20937920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (8)
Abbreviated applications
- SELENIOUS ACIDZYDUS PHARMSANDA 21932220263 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDKINDOSANDA 2194722026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDSTIRAANDA 21853620252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDCIPLAANDA 21866120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION INTRAVENOUS Discontinued — EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Discontinued — - SELENIOUS ACIDGLANDANDA 2196292025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDASPIROANDA 21963320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDSUN PHARMANDA 2195472025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Rx AP - SELENIOUS ACIDFRESENIUS KABI USAANDA 2187792025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML) SOLUTION INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12150957 | in 15 yr 2 mo | U-4039 | |
| 11998565 | in 15 yr 2 mo | Product |
Approval history
FDA approval span
First approval
7 yr 4 mo ago
Most recent approval
1 mo ago
Approvals span 2019–2026 across 9 FDA applications.
Brand (NDA) 111%
Generic (ANDA) 889%
Selenious acid: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
