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Last Updated: August 15, 2020

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ACUVAIL Drug 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 two Paragraph IV challenges.

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. Forty-six suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Drug patent expirations by year for ACUVAIL
Drug Prices for ACUVAIL

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Recent Clinical Trials for ACUVAIL

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

SponsorPhase
Arthroplasty Foundation, Inc.Phase 4
University of LouisvillePhase 4
Food and Drug Administration (FDA)Phase 2

See all ACUVAIL clinical trials

Paragraph IV (Patent) Challenges for ACUVAIL
Tradename Dosage Ingredient NDA Submissiondate
ACUVAIL SOLUTION/DROPS;OPHTHALMIC ketorolac tromethamine 022427 2011-08-24

US Patents and Regulatory Information for ACUVAIL

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

Supplementary Protection Certificates for ACUVAIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 92923 Luxembourg   Start Trial 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 122015000111 Germany   Start Trial PRODUCT NAME: OKULARE IRRIGATIONSLOESUNG, WELCHE PHENYLEPHRIN ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UND KETOROLAC ODER DESSEN PHARMAZEUTISCH WIRKSAMES SALZ UMFASST; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 300784 Netherlands   Start Trial PRODUCT NAME: EEN OCULAIRE OPLOSSING WELKE FENYLEFRINE BEVAT, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ALSMEDE KETOROLAC, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 2015/071 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School

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