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.
DrugPatentWatch® Litigation and Generic Entry Outlook for Acuvail
A generic version of ACUVAIL was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.
Summary for ACUVAIL
International Patents: | 63 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 11 |
Patent Applications: | 3,543 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ACUVAIL |
What excipients (inactive ingredients) are in ACUVAIL? | ACUVAIL excipients list |
DailyMed Link: | ACUVAIL at DailyMed |


Recent Clinical Trials for ACUVAIL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Allergan | Phase 1 |
Stephen J. Kim, MD | Phase 1 |
National Eye Institute (NEI) | Phase 1 |
Pharmacology for ACUVAIL
Drug Class | Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for ACUVAIL
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 |