Upgrade for Complete Access See Plans and Pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Harvard Business School
McKinsey
Dow
Mallinckrodt

Last Updated: June 29, 2022

ACULAR LS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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

Acular Ls is a drug marketed by Allergan 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. 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 Acular Ls

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

  Try it Free

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: 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
Patented Use: A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING OCULAR PAIN

Ketorolac tromethamine compositions for treating or preventing ocular pain
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan ACULAR LS ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 021528-001 May 30, 2003 AT RX Yes Yes See Plans and Pricing See Plans and Pricing 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 ACULAR LS

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

Country Patent Number Title Estimated Expiration
Hungary 199072 ANTIMICROBAL CONSERVING COMPOSITION AND PROCESS FOR PRODUCTION OF COMPOSITIONS FOR OCULIST PURPUSES See Plans and Pricing
Norway 175404 See Plans and Pricing
Japan H0696542 See Plans and Pricing
Hungary 210610 See Plans and Pricing
South Africa 8806757 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACULAR LS

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
1534313 122015000111 Germany See Plans and Pricing PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313 C 2015 055 Romania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Merck
Medtronic
Baxter
Harvard Business School

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.