You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School

Last Updated: July 13, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022427

Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 022427 describes ACUVAIL, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are four patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ACUVAIL profile page.

The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 022427
Ingredient:ketorolac tromethamine
Formulation / Manufacturing:see details
Pharmacology for NDA: 022427
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 022427
Suppliers and Packaging for NDA: 022427
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427 NDA Allergan, Inc. 0023-3507 0023-3507-05 5 VIAL, SINGLE-USE in 1 CARTON (0023-3507-05) > .4 mL in 1 VIAL, SINGLE-USE
ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427 NDA Allergan, Inc. 0023-3507 0023-3507-30 30 VIAL, SINGLE-USE in 1 CARTON (0023-3507-30) > .4 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 022427
Tradename Dosage Ingredient NDA Submissiondate
ACUVAIL SOLUTION/DROPS;OPHTHALMIC ketorolac tromethamine 022427 2011-08-24

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.45%
Approval Date:Jul 22, 2009TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Aug 15, 2029Product Flag?YSubstance Flag?YDelist Request?
Patent:  Start TrialPatent Expiration:Mar 7, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Aug 5, 2024Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Express Scripts

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.