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Last Updated: November 21, 2024

ACULAR Drug Patent Profile


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

Acular is a drug marketed by Abbvie and Allergan and is included in three NDAs. There are eight patents protecting this drug.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Acular

A generic version of ACULAR was approved as ketorolac tromethamine by MYLAN on May 16th, 1997.

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

See drug prices for ACULAR

Drug Sales Revenue Trends for ACULAR

See drug sales revenues for ACULAR

Recent Clinical Trials for ACULAR

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

SponsorPhase
Emory UniversityEarly Phase 1
University of LouisvillePhase 4
Arthroplasty Foundation, Inc.Phase 4

See all ACULAR clinical trials

Pharmacology for ACULAR

US Patents and Regulatory Information for ACULAR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Abbvie ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ACULAR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Sign Up ⤷  Sign Up
Abbvie ACULAR ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 019700-001 Nov 9, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ACULAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 C 2015 055 Romania ⤷  Sign Up PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313 76/2015 Austria ⤷  Sign Up PRODUCT NAME: PHENYLEPHRIN, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, UND KETOROLAC, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/1018 (MITTEILUNG) 20150730
1534313 CR 2015 00072 Denmark ⤷  Sign Up PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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