NDAOPHTHALMICSOLUTION/DROPS
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
6
Data completeness
6/8 — Strong
ACUVAIL (ketorolac tromethamine) by AbbVie is anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. First approved in 2009.
Drug data last refreshed 8h ago · AI intelligence enriched 11h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACUVAIL is a topical ophthalmic solution containing ketorolac tromethamine, a nonsteroidal anti-inflammatory drug (NSAID) administered as eye drops. It inhibits prostaglandin biosynthesis to reduce inflammation and pain in the eye. The drug is used to manage postoperative ocular inflammation and pain following cataract surgery.
$0.174MPart D
LOE Approaching2.9 years to LOEProduct approaching loss of exclusivity with modest Part D utilization (332 claims in 2023); brand team likely focused on maximizing remaining patent-protected period or transitioning to generic support strategies.
Mechanism of Action
anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (6)
Comparison Of Ketorolac Tromethamine Oral Drops Versus Naproxen For Moderate to Severe Back Pain Treatment
Started Mar 2013
78 enrolled
Back Pain
Comparison Of Ketorolac Tromethamine Versus Naproxen For Moderate to Severe Back Pain Treatment
Started Mar 2013
83 enrolled
Back Pain
Safety and Efficacy of Olopatadine Hydrochloride/Ketorolac Tromethamine Ophthalmic Solution Compared With Olopatadine Hydrochloride Ophthalmic Solution in Patients With Seasonal Allergic Conjunctivitis
Started Dec 2010
129 enrolled
Rhinitis, Allergic, SeasonalConjunctivitis, Allergic
A 6 Month Study to Evaluate the Safety, Analgesic Efficacy of ACUVAIL™ (Ketorolac Tromethamine Ophthalmic Solution) 0.45%, in Post-PRK Corneal Wound Healing
Started Aug 2010
10 enrolled
Must be PRK Candidate
A Comparison of Prostaglandin E2 (PGE2) Inhibition of Acuvail(Ketorolac 0.45%), Xibrom (Bromfenac 0.09%)and Nevanac (Nepafenac)in Patients Undergoing Phacoemulsification
Started Oct 2009
126 enrolled
Cataracts
Worked on ACUVAIL at AbbVie? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.