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:	4,710
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

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					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
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003

International Patents for ACULAR LS

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016077726
Canada	1328614	SYSTEME DE CONSERVATION DES COMPOSITIONS OPHTALMIQUES (PRESERVATIVE SYSTEM FOR OPHTHALMICS FORMULATIONS)
Ireland	60717	"Preservative system for ophthalmic formulations"
Canada	2967362	SYSTEMES DE LIT ET PROCEDES ASSOCIES (BED SYSTEMS AND METHODS)
Norway	175404

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	76/2015	Austria		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	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	C 2015 055	Romania		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	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
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

Market Dynamics and Financial Trajectory for ACULAR LS

Last updated: July 28, 2025

Introduction

ACULAR LS (Ketorolac Tromethamine Ophthalmic Solution 0.44%) is a non-steroidal anti-inflammatory drug (NSAID) formulated specifically for ocular use. Approved by the FDA for the treatment of postoperative ocular inflammation and pain, ACULAR LS has carved a notable niche within the ophthalmic pharmaceutical landscape. Understanding its market dynamics and financial trajectory necessitates an examination of evolving ophthalmic treatment paradigms, competitive positioning, regulatory influences, and economic drivers shaping its growth potential.

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Market Overview

The global ophthalmic pharmaceutical market is projected to reach approximately $41.8 billion by 2027, with a compound annual growth rate (CAGR) of around 4.8% (Research and Markets, 2022). Within this expansive sector, NSAIDs like ACULAR LS address a niche focused on postoperative inflammation, ocular pain management, and specific ocular inflammatory conditions.

ACULAR LS’s primary indications are for reducing postoperative ocular inflammation following cataract surgery and other intraocular procedures. Its unique formulation—delivering an extended-release, preservative-free solution—improves patient compliance and reduces dosing frequency, offering a competitive edge over traditional NSAID drops.

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Market Drivers

1. Rising Prevalence of Cataract Surgery

Cataract surgery remains the most common ocular procedure globally, with over 28 million performed annually worldwide (American Academy of Ophthalmology, 2021). An aging population, particularly in North America, Europe, and parts of Asia, stimulates increased demand for postoperative anti-inflammatory therapies, directly benefiting ACULAR LS.

2. Enhanced Patient Compliance

The extended-release formulation minimizes the need for multiple daily instillations, improving adherence—critical in postoperative care. This convenience aligns with modern patient preferences and reduces the risk of non-compliance-related complications.

3. Regulatory Approvals and Expanding Indications

Initially approved in 2019 for postoperative inflammation and pain, investigations into broader indications—such as chronic ocular inflammation—could expand the market. Regulatory agencies also favor preservative-free options, favorably influencing ACULAR LS's positioning.

4. Competitive Positioning and Differentiation

Unlike traditional NSAIDs that require multiple administrations, ACULAR LS’s once-daily dosing enhances its attractiveness among ophthalmologists and patients, providing a strategic edge over competitors like bromfenac (e.g., Prolensa) and other NSAID formulations.

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Market Challenges

1. Competition from Alternative NSAIDs and Steroids

Market penetration faces competition from oral NSAIDs, corticosteroids, and newer topical agents offering similar or improved efficacy. The presence of generics for similar drugs could pressure pricing and margins.

2. Reimbursement and Pricing Pressures

Insurance coverage and healthcare reimbursement policies influence market adoption. Flagship ophthalmic drugs often experience downward pricing pressure amidst the push for cost-effective care.

3. Developing Market for Broader Ophthalmic Indications

While promising, the extension into other ophthalmic conditions requires rigorous clinical validation, regulatory approval, and significant marketing investment.

4. Patent Challenges and Patent Expiry Risks

Patent exclusivity offers financial protection; however, patent expirations or litigation could erode market advantages. As formulary competition intensifies, this risk amplifies.

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Financial Trajectory and Revenue Forecasts

1. Revenue Generation and Growth Trends

ACULAR LS’s revenue trajectory depends heavily on its uptake in cataract surgery postoperative care, clinical validation for expanding indications, and pharmaceutical market dynamics.

• Initial Launch Performance: Post-approval in 2019, ACULAR LS experienced a steady uptake driven by its unique formulation and clinical efficacy data.
• Growth Catalysts: Increased cataract surgeries, enhanced physician awareness, and favorable reimbursement policies significantly influenced revenue growth.

2. Market Expansion Potential

Analysis from industry reports suggests that ophthalmic NSAIDs could witness a CAGR of 4-5% over the next five years, driven by demographic trends and technological innovation. ACULAR LS, with its differentiated profile, is positioned to outperform the broader NSAID segment, potentially achieving higher double-digit growth annually in targeted niches.

3. Pricing and Market Penetration Strategies

Pricing strategies balance maintaining margins with market adoption. Premium pricing remains feasible due to its innovative formulation, but price erosion from generics and competition could perceptibly restrict margins over time.

4. Impact of Clinical Trials and Regulatory Changes

Positive clinical trial outcomes or expanded indications could significantly boost revenue prospects. Conversely, delayed approvals or unfavorable trial results could hinder growth trajectories.

5. Partnership and Licensing Opportunities

Strategic alliances with ophthalmic device firms or regional licensing agreements can unlock additional revenue channels and accelerate market penetration in emerging markets (e.g., Asia-Pacific, Latin America).

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Key Market Segments

Segment	Market Trends	Impact on ACULAR LS
Postoperative Cataract Care	Largest segment; consistently growing with aging populations	Core driver for current revenue; expansion here crucial
Ophthalmic Inflammatory Disorders	Potential for broader use; ongoing research	Future growth avenue; regulatory approval needed
Emerging Markets	Rising ophthalmic procedure volumes; lower penetration	Critical for long-term global growth; requires strategic localization

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Future Outlook

The financial forecast indicates a cautiously optimistic trajectory for ACULAR LS, contingent on clinical validation, competitive actions, and regulatory landscapes. With an aging global population and increasing cataract surgeries, the demand for effective, patient-friendly anti-inflammatory agents like ACULAR LS is expected to grow. The drug’s competitive differentiation offers opportunities for premium pricing and increased market share, especially if the company leverages targeted marketing and expands indications.

In the short term, revenue growth may normalize as initial adoption peaks and competition escalates. Long-term, sustained growth hinges on innovation in formulations, clinical endorsements, and geographical expansion.

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Key Takeaways

• Market Positioning: ACULAR LS benefits from its extended-release, preservative-free profile, emphasizing improved compliance and convenience for postoperative patients.
• Growth Drivers: Rising cataract surgeries, elderly populations, and positive clinical data are primary growth catalysts.
• Challenges: Competitor NSAIDs/steroids, pricing pressures, and patent life remain critical considerations.
• Financial Trajectory: Anticipated steady growth aligned with global ophthalmic procedural volumes, with potential for acceleration via indication expansion.
• Strategic Focus: Building awareness in emerging markets and investing in clinical trials for broader indications will unlock additional revenue streams.

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FAQs

1. What distinguishes ACULAR LS from other NSAIDs used in ophthalmology?
ACULAR LS’s once-daily, extended-release formulation offers enhanced patient adherence, reduces dosing frequency, and minimizes preservative exposure — attributes that set it apart from traditional NSAID drops requiring multiple daily applications.

2. How significant is the impact of demographic trends on ACULAR LS’s market potential?
Aging populations worldwide increase the volume of cataract surgeries, establishing a steady demand base for postoperative anti-inflammatory treatments like ACULAR LS.

3. What are the primary competitive threats facing ACULAR LS?
Market threats include generic NSAIDs, steroid alternatives, and evolving treatments that offer similar efficacy with lower costs or improved safety profiles.

4. Can ACULAR LS expand into indications beyond postoperative inflammation?
While currently approved for postoperative use, ongoing clinical research could support its broader application in chronic ocular inflammation, potentially expanding its market reach.

5. How do reimbursement policies influence the market trajectory for ACULAR LS?
Reimbursement frameworks directly affect doctor prescribing behaviors and patient access; favorable policies facilitate adoption, while restrictive reimbursement can hinder growth.

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References

[1] Research and Markets. Ophthalmic Pharmaceuticals Market Forecast (2022).
[2] American Academy of Ophthalmology. Cataract Surgery Statistics (2021).
[3] Company reports and regulatory filings.