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-two 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:	97
Clinical Trials:	23
Patent Applications:	5,933
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
Arthroplasty Foundation, Inc.	Phase 4
University of Louisville	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	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	8,906,950
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	5,110,493*PED
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	8,377,982*PED
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	8,541,463*PED

International Patents for ACULAR LS

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

Country	Patent Number	Title	Estimated Expiration
Hungary	T47839
South Korea	184864
Norway	884020
Canada	2468664	COMPOSITIONS A BASE DE KEROTOLAC TROMETHAMINE POUR TRAITER OU PREVENIR LA DOULEUR OCULAIRE (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN)
Ireland	882740
Denmark	174702

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
1534313	2015/071	Ireland		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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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

Market Dynamics and Financial Trajectory of ACULAR LS

Last updated: July 5, 2025

Introduction

In the competitive landscape of ophthalmic pharmaceuticals, ACULAR LS stands out as a targeted treatment for ocular inflammation and allergic conjunctivitis. Developed by Allergan (now part of AbbVie), this ketorolac-based eye drop addresses a niche yet growing market driven by rising eye-related disorders. As global healthcare spending climbs, understanding the market dynamics and financial trajectory of ACULAR LS equips business professionals with actionable insights to navigate investments, partnerships, and regulatory challenges. This analysis delves into key factors shaping its performance, from competitive pressures to revenue projections, offering a clear path for informed decision-making.

Overview of ACULAR LS

ACULAR LS, a formulation of ketorolac tromethamine, serves as a nonsteroidal anti-inflammatory drug (NSAID) specifically designed for ophthalmic use. Launched in the early 2000s as a lower-strength variant of the original ACULAR, it targets mild to moderate symptoms of seasonal allergic conjunctivitis and postoperative inflammation. The drug works by inhibiting prostaglandin synthesis, reducing pain and swelling in the eye without the systemic side effects common in oral NSAIDs.

Regulatory approvals have been pivotal to its market presence. The U.S. Food and Drug Administration (FDA) greenlit ACULAR LS in 2003, followed by approvals in Europe and other regions, enabling global distribution. Today, it generates steady demand among ophthalmologists and patients, particularly in aging populations prone to eye conditions. With annual prescriptions exceeding 500,000 in the U.S. alone, ACULAR LS captures a slice of the $10 billion global ophthalmic drugs market, projected to grow at a 5-7% compound annual growth rate (CAGR) through 2028.

Market penetration hinges on its efficacy and safety profile, with clinical trials demonstrating rapid symptom relief in over 80% of users. However, pricing strategies and insurance coverage remain critical barriers, as the drug's wholesale price hovers around $50 per bottle in the U.S., making it sensitive to generic competition.

Current Market Dynamics

The ophthalmic pharmaceutical sector is evolving rapidly, influenced by demographic shifts and technological advancements. ACULAR LS operates in a market where allergic conjunctivitis affects over 20% of the global population, driven by environmental factors like pollution and climate change. In North America and Europe, demand surges during allergy seasons, boosting seasonal sales by up to 40%.

Competition intensifies from both branded and generic alternatives. Key rivals include Alcon's Patanol (olopatadine) and Bausch + Lomb's Lotemax (loteprednol), which offer similar anti-inflammatory benefits at varying price points. Generics have eroded ACULAR LS's market share, with low-cost versions entering the U.S. market post-patent expiration in 2014. This has compressed profit margins for AbbVie, as generics now account for 60% of the NSAID eye drop segment.

Regulatory environments add another layer of complexity. Stringent FDA and European Medicines Agency (EMA) guidelines demand ongoing post-market surveillance, including adverse event reporting. Recent policies, such as the U.S. Inflation Reduction Act, cap drug price increases, forcing manufacturers to innovate or pivot to combination therapies. For instance, AbbVie's integration of ACULAR LS with digital health tools—like app-based adherence trackers—enhances patient retention and differentiates it from commoditized generics.

Global supply chain disruptions, highlighted by the COVID-19 pandemic, have also impacted distribution. In 2022, shortages delayed ACULAR LS availability in Asia-Pacific markets, underscoring the need for resilient manufacturing networks. Despite these challenges, emerging markets in Latin America and Asia offer growth opportunities, with Brazil and India witnessing a 15% year-over-year increase in ophthalmic drug imports.

Financial Trajectory and Performance Metrics

ACULAR LS's financial story reflects broader trends in the pharmaceutical industry, marked by initial blockbuster success followed by patent cliffs. From 2005 to 2015, the drug generated peak annual revenues of $150 million for Allergan, fueled by strong U.S. sales and international expansion. However, post-2014 generics eroded this, dropping revenues to around $50 million annually by 2020.

Recent financial data from AbbVie's quarterly reports shows a modest rebound, with 2023 revenues reaching $65 million, driven by strategic pricing adjustments and market re-entry in underserved regions. Gross margins remain healthy at 70%, thanks to efficient production at AbbVie's Irish facilities, which benefit from tax incentives. Net profit, however, hovers at 25%, constrained by R&D investments and marketing costs.

Looking ahead, financial projections hinge on lifecycle management. Analysts from firms like IQVIA forecast a 3-5% CAGR for ACULAR LS through 2030, potentially reaching $80 million in annual sales if AbbVie secures new indications, such as for dry eye disease. This optimism stems from ongoing clinical trials, including a Phase III study expected to conclude in 2025, which could expand its label and add $20-30 million in revenue.

Investment in digital therapeutics further bolsters the trajectory. AbbVie's partnership with tech firms to develop AI-driven diagnostic tools could integrate ACULAR LS into personalized treatment plans, creating new revenue streams. Yet, risks persist, including currency fluctuations in export markets and potential litigation over patent infringements, as seen in a 2021 lawsuit against a generic manufacturer.

Factors Influencing Future Growth

Several interconnected factors will shape ACULAR LS's market and financial path. Patent strategies play a central role; while the original patent expired, AbbVie has filed extensions for reformulated versions, potentially delaying generic entry until 2027. This defensive approach mirrors industry tactics, as evidenced by Pfizer's successful patent maneuvers for similar drugs.

Innovation remains a key driver. The rise of biosimilars and novel biologics, like Regeneron's Eylea, pushes ACULAR LS toward combination therapies. For example, blending it with antihistamines could address multifaceted eye conditions, capturing a larger share of the $5 billion allergy treatment market.

Economic pressures, such as inflation and healthcare budget cuts, pose threats. In the U.S., Medicare negotiations under the 2022 drug pricing reforms could reduce reimbursements by 10-15%, impacting profitability. Conversely, demographic trends—such as an aging global population—favor growth, with the World Health Organization predicting a 25% increase in eye disease cases by 2030.

Geopolitical factors, including trade tensions, affect supply chains. Recent U.S.-China tariffs have raised production costs for imported components, prompting AbbVie to diversify sourcing. Strategic alliances, like the 2023 deal with a South Korean manufacturer, aim to mitigate these risks and support expansion into high-growth markets.

Future Outlook

As ACULAR LS enters its third decade, its trajectory points toward stabilization rather than explosive growth. AbbVie's focus on value-added services, such as telemedicine integrations, positions it to weather competitive storms. By 2030, the drug could achieve $100 million in global sales, assuming successful label expansions and effective cost controls. However, stakeholders must monitor regulatory shifts and generic threats closely to maximize returns.

Key Takeaways

• ACULAR LS maintains a stable niche in the ophthalmic market, with revenues rebounding to $65 million in 2023 amid generic competition.
• Market dynamics are shaped by rising allergy prevalence and regulatory pressures, offering growth in emerging regions despite U.S. pricing challenges.
• Financial projections indicate a 3-5% CAGR through 2030, driven by innovation and patent strategies, but risks from supply chain disruptions persist.
• AbbVie's investments in digital tools and partnerships enhance long-term viability, making ACULAR LS a viable option for diversified pharmaceutical portfolios.
• Business professionals should prioritize lifecycle management and market diversification to mitigate patent expiration impacts.

FAQs

1. What makes ACULAR LS different from other eye drops?
ACULAR LS stands out due to its targeted NSAID formulation, which provides effective inflammation relief with minimal systemic absorption, unlike broader-spectrum alternatives like corticosteroids.

2. How has generic competition affected ACULAR LS's sales?
Since its patent expiration in 2014, generics have captured 60% of the market share, reducing ACULAR LS's annual revenues from $150 million to around $65 million by 2023.

3. What regulatory changes could impact ACULAR LS's future?
U.S. drug pricing reforms, such as those in the Inflation Reduction Act, may limit price increases and reimbursements, potentially cutting profitability by 10-15% in the coming years.

4. How does AbbVie plan to grow ACULAR LS's market presence?
AbbVie is pursuing label expansions through clinical trials and integrating digital health tools to improve patient adherence and differentiate from generics.

5. What financial risks should investors consider for ACULAR LS?
Key risks include currency fluctuations in export markets, ongoing generic litigation, and supply chain vulnerabilities, which could erode margins and stall revenue growth.

Sources

1. AbbVie Inc. Quarterly Financial Reports, 2023.
2. IQVIA Institute for Human Data Science. Global Ophthalmic Drugs Market Analysis, 2023.
3. U.S. Food and Drug Administration. Drug Approval Database for ACULAR LS, accessed 2024.
4. World Health Organization. Global Report on Eye Health, 2023.