ACULAR LS Drug Patent Profile

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

Acular Ls is a drug marketed by Abbvie and is included in one NDA. There is one patent 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-three 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 16^th, 1997.

Summary for ACULAR LS

International Patents:	5
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	23
Patent Applications:	7,086
Drug Prices:	Drug price information for ACULAR LS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACULAR LS
What excipients (inactive ingredients) are in ACULAR LS?	ACULAR LS excipients list
DailyMed Link:	ACULAR LS at DailyMed

See drug prices for ACULAR LS

Recent Clinical Trials for ACULAR LS

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

Sponsor	Phase
Emory University	Early Phase 1
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4

See all ACULAR LS clinical trials

Pharmacology for ACULAR LS

Drug Class	Cyclooxygenase Inhibitor Nonsteroidal Anti-inflammatory Drug
Mechanism of Action	Cyclooxygenase Inhibitors

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 one US patents.

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		RX	Yes	No	8,008,338*PED				Y

Expired US Patents for ACULAR LS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,648,107
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,946,281
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	9,216,167

International Patents for ACULAR LS

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

Country	Patent Number	Title	Estimated Expiration
Austria	74750
Australia	2204288
Australia	5220190

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CA 2015 00072	Denmark		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	92923	Luxembourg		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	15C0090	France		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

Last updated: July 28, 2026

Acular LS (ketorolac tromethamine ophthalmic solution, 0.4%) market dynamics and financial trajectory: exclusivity, competition, and revenue outlook

Executive summary: Acular LS is a branded ketorolac ophthalmic used for post-surgical ocular pain/inflammation, positioned in the NSAID eye-drop segment against generic ketorolac (including Acular, ketorolac 0.5% generics) and broad competitive pressure from cheaper generics and alternative NSAID classes. Financial trajectory is defined less by ongoing brand-level innovation and more by (1) patent/exclusivity wind-down versus (2) the pace of generic entry into the ketorolac ophthalmic category, (3) channel inventory and prescribing inertia after label “stability” periods, and (4) payer and wholesaler cost pressure that typically accelerates when AWP-to-net spreads compress.

Because this request requires a complete, accurate market-and-financial read (drug-level sales, payer data, NRx, and Orange Book/FDA exclusivity status) and that information is not provided here, a complete and accurate response cannot be produced under the operating constraints.