FDA Orange Book · active-ingredient family
Dehydrated alcohol
Dehydrated alcohol: 2 brands, 4 generics; first approved Jun 21, 2018; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
0
Presentations
7
Brand (NDA) products
Originator applications
- DEHYDRATED ALCOHOLRLDRSBE PHARMSNDA 2149882025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 98% (5ML) SOLUTION INTRAVENOUS Rx — - ABLYSINOLRLDBPI LABSNDA 20798720182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99% (1ML) SOLUTION INTRA-ARTERIAL Discontinued — 99% (5ML) SOLUTION INTRA-ARTERIAL Rx AP
Generic (ANDA) products (4)
Abbreviated applications
- DEHYDRATED ALCOHOLINGENUS PHARMS LLCANDA 2195692025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99% (5ML) SOLUTION INTRA-ARTERIAL Rx AP - DEHYDRATED ALCOHOLACCORD HLTHCAREANDA 2178452025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99% (5ML) SOLUTION INTRA-ARTERIAL Rx AP - DEHYDRATED ALCOHOLBRECKENRIDGEANDA 2194442025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99% (5ML) SOLUTION INTRA-ARTERIAL Rx AP - DEHYDRATED ALCOHOLXGEN PHARMSANDA 2194002025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 99% (5ML) SOLUTION INTRA-ARTERIAL Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- ODE-521Orphan-drug exclusivity (7 years)
in 6 yr 3 mo
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
8 yr 3 mo ago
Most recent approval
10 mo ago
Approvals span 2018–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Dehydrated alcohol: 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.
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