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Last Updated: March 29, 2024

Acular LS Drug Patent Profile


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Which patents cover Acular Ls, and when can generic versions of Acular Ls launch?

Acular Ls is a drug marketed by Abbvie and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has five patent family members in three countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Acular Ls

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

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Drug patent expirations by year for Acular LS
Drug Prices for Acular LS

See drug prices for Acular LS

Recent Clinical Trials for Acular LS

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 LS clinical trials

Pharmacology for Acular LS
Paragraph IV (Patent) Challenges for ACULAR LS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACULAR LS Ophthalmic Solution ketorolac tromethamine 0.4% 021528 1 2005-01-28

US Patents and Regulatory Information for Acular LS

Acular LS is protected by four US patents.

Patents protecting Acular LS

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING OCULAR PAIN

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: A METHOD OF TREATING OCULAR PAIN AND/OR ENHANCING OCULAR COMFORT

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

See the table below for patents covering Acular LS around the world.

Country Patent Number Title Estimated Expiration
South Korea 950013754 ⤷  Try a Trial
Hong Kong 27894 PRESERVATIVE SYSTEM FOR OPHTALMIC FORMULATIONS ⤷  Try a Trial
Japan 2954642 ⤷  Try a Trial
Denmark 505688 ⤷  Try a Trial
European Patent Office 3777808 SYSTÈMES DE LIT (BED SYSTEMS) ⤷  Try a Trial
Philippines 25422 PRESERVATIVE SYSTEM FOR OPHTHALMICS ⤷  Try a Trial
Germany 3870111 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for Acular LS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1534313 C 2015 055 Romania ⤷  Try a Trial 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 CA 2015 00072 Denmark ⤷  Try a Trial PRODUCT NAME: OKULAER SKYLLEVAESKE OMFATTENDE PHENYLEPHRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HYDROCHLORID OG KETOROLAC ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313 CR 2015 00072 Denmark ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313 76/2015 Austria ⤷  Try a Trial 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 300784 Netherlands ⤷  Try a Trial PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313 92923 Luxembourg ⤷  Try a 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 ⤷  Try a Trial PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.