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Last Updated: June 29, 2022

ACUVAIL Drug Patent Profile


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When do Acuvail patents expire, and what generic alternatives are available?

Acuvail is a drug marketed by Allergan and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-one suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for ACUVAIL
Drug patent expirations by year for ACUVAIL
Drug Prices for ACUVAIL

See drug prices for ACUVAIL

Recent Clinical Trials for ACUVAIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AllerganPhase 1
Stephen J. Kim, MDPhase 1
National Eye Institute (NEI)Phase 1

See all ACUVAIL clinical trials

Paragraph IV (Patent) Challenges for ACUVAIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACUVAIL Opthalmic Solution ketorolac tromethamine 0.45% 022427 1 2011-08-24

US Patents and Regulatory Information for ACUVAIL

ACUVAIL is protected by four US patents.

Patents protecting ACUVAIL

Ketorolac tromethamine compositions for treating ocular pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for delivery of therapeutics into the eyes and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Compositions for delivery of therapeutics into the eyes and methods for making and using same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan ACUVAIL ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 022427-001 Jul 22, 2009 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ACUVAIL

See the table below for patents covering ACUVAIL around the world.

Country Patent Number Title Estimated Expiration
Spain 2657845 See Plans and Pricing
European Patent Office 2555770 COMPOSITIONS DE KÉTOROLAC POUR LA CICATRISATION DE LÉSIONS CORNÉENNES (KETOROLAC COMPOSITIONS FOR CORNEAL WOUND HEALING) See Plans and Pricing
Ukraine 97734 КОМПОЗИЦИИ КЕТОРОЛАКА ТРОМЕТАМИНА ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ ГЛАЗНОЙ БОЛИ;КОМПОЗИЦІЇ КЕТОРОЛАКУ ТРОМЕТАМІНУ ДЛЯ ЛІКУВАННЯ АБО ПРОФІЛАКТИКИ ОЧНОГО БОЛЮ (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACUVAIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 92923 Luxembourg See Plans and Pricing PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730
1534313 2015/071 Ireland See Plans and Pricing PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 15C0090 France See Plans and Pricing PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Baxter
Medtronic
Mallinckrodt
Merck
Harvard Business School

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