ACULAR Drug Patent Profile

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

Acular is a drug marketed by Abbvie and Allergan and is included in three NDAs. There is one patent protecting this drug.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Acular

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

Summary for ACULAR

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	23
Patent Applications:	4,210
Drug Prices:	Drug price information for ACULAR
What excipients (inactive ingredients) are in ACULAR?	ACULAR excipients list
DailyMed Link:	ACULAR at DailyMed

See drug prices for ACULAR

See drug sales revenues for ACULAR

Recent Clinical Trials for ACULAR

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 clinical trials

Pharmacology for ACULAR

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

US Patents and Regulatory Information for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	AT	RX	Yes	Yes
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,008,338*PED				Y
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No

Expired US Patents for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	4,089,969
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	4,454,151*PED
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992	5,110,493*PED

International Patents for ACULAR

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

Country	Patent Number	Title	Estimated Expiration
Denmark	151335
Germany	2760330
Germany	3310079
Japan	2954642
Germany	2731678
European Patent Office	0390071
Slovenia	7711721	PROCESS FOR OBTAINING 5-AROYL-1,2 DEHYDRO-3H-PYRROLO (1,2-A)PYRROL-1-CARBOXYLIC DERIVATIVES

Supplementary Protection Certificates for ACULAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	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 for the Pharmaceutical Drug: ACULAR

Last updated: July 29, 2025

Introduction

ACULAR, a trademarked formulation of ketorolac tromethamine, is a nonsteroidal anti-inflammatory drug (NSAID) primarily employed as an ophthalmic solution for managing post-operative ocular inflammation and pain. Since its approval, ACULAR has established itself within the ophthalmology segment, experiencing fluctuating market dynamics influenced by competitive innovations, regulatory changes, and shifting clinical practices. This analysis endeavors to elucidate the current market landscape for ACULAR, examine their financial trajectories, and project future trends based on pivotal industry and regulatory factors.

Market Overview

Product Profile and Therapeutic Positioning

ACULAR’s core indication revolves around alleviating ocular pain and inflammation following corneal refractive surgery and other ocular procedures (e.g., cataract extraction). Its mechanism involves inhibiting prostaglandin synthesis, thereby reducing inflammation and related discomfort. The drug’s safety profile and efficacy have historically contributed to its widespread adoption in ophthalmic clinics worldwide.

Market Penetration and Adoption

As a product approved in multiple regions (notably the U.S., Europe, and Asia), ACULAR benefits from established prescribing habits among ophthalmologists. Its market penetration is strongest in developed countries, where surgical volumes for cataract and refractive procedures are substantial. However, in emerging markets, lower penetration exists due to limited access and local regulatory hurdles.

Key Competitors and Substitutes

The ophthalmic NSAID landscape includes competitors like bromsite (bromfenac), nevanac (nepafenac), and other corticosteroid alternatives. Recent entries offering enhanced formulations, such as preservative-free options and extended-release devices, challenge ACULAR’s market share, necessitating continuous differentiation and innovation.

Market Dynamics

Regulatory Environment and Patent Landscape

ACULAR’s original patents have expired or are nearing expiration in several jurisdictions, opening pathways for generics and biosimilars to enter the market. The entrance of generics generally precipitates price erosion, impacting profit margins. However, regulatory barriers, such as formulation-specific patents and clinical data exclusivity, can influence the pace of generic penetration.

Pricing Strategies and Reimbursement Policies

Pricing strategies for ACULAR have historically aligned with the premium ophthalmic NSAID segment, supported by positive clinical outcomes. Reimbursement policies, especially in managed healthcare systems, heavily influence patient access and prescribing patterns. In countries with strict cost-control measures, off-label use reductions and formulary restrictions can diminish market volume.

Emerging Trends: Preservative-Free and Combination Formulations

Innovations like preservative-free versions enhance safety profiles, appealing to clinics focused on patient comfort and safety. Combination therapies, blending NSAIDs with corticosteroids, are gaining popularity, potentially reducing demand for monotherapy such as ACULAR.

Impact of the COVID-19 Pandemic

The COVID-19 pandemic temporarily suppressed elective surgeries, reducing overall ophthalmic procedural volumes and thus ACULAR’s consumption. Conversely, adoption of tele-ophthalmology has increased, influencing outpatient prescription practices and potentially delaying or accelerating the drug’s market recovery depending on healthcare system adaptations.

Financial Trajectory Analysis

Historical Revenue Performance

ACULAR’s revenue has shown initial steady growth, driven by increasing surgical volumes, particularly in cataract and refractive surgeries. Subsequent patent expirations and market saturation led to a slowdown, compounded by the emergence of generics.

Current Financial Position

In recent years, the revenue trajectory has plateaued or slightly declined in mature markets, offsetting gains from newer regional markets. Cost diversification, such as investments in advanced formulations and targeted marketing, have maintained profitability margins.

Forecasting Future Revenue Streams

1. Patent and Market Exclusivity Outlook: Expiry of key patents within the next 2-3 years in major markets is projected to lead to significant generic competition, reducing unit prices and overall revenue.

2. Regional Growth Opportunities: Emerging markets present a lucrative expansion opportunity, particularly in Asia-Pacific, where surgical volumes are rising sharply. Regulatory approvals and local manufacturing bolster market entry prospects.

3. Product Innovation and Differentiation: Investment in preservative-free or combination therapies could secure premium pricing and capture shifted patient preferences.

4. Digital and Data-Driven Strategies: Adoption of telemedicine protocols and precise market analytics can optimize distribution channels, reducing costs and enhancing revenue.

Risks and Challenges

• Drastic pricing reductions due to generic entry threaten profit margins.
• Increasing competition from newer formulations and alternative therapies.
• Regulatory delays or restrictions impacting market expansion.
• Pricing pressures in healthcare systems emphasizing cost-effectiveness.

Market Growth Drivers and Constraints

Drivers	Constraints
Rising global ophthalmic surgical procedures	Patent expirations leading to generic competition
Innovation in preservative-free formulations	Market saturation in mature regions
Increasing awareness and early intervention	Cost constraints in emerging markets
Expansion into emerging markets	Stringent regulatory environments

Concluding Insights

The trajectory of ACULAR’s market and financial performance is tightly intertwined with patent status, evolving clinical practices, and regional healthcare policies. While current revenue streams face pressure from generic competition, opportunities in emerging markets and product diversification offer pathways for stability. Strategic investments in formulation innovation, market expansion, and digital health solutions can bolster ACULAR’s market position amid a competitive landscape.

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Key Takeaways

• Patent Expiry and Generic Competition: The imminent expiration of key patents will drive significant generics entry, potentially reducing prices and revenues.
• Regional Market Expansion: High-growth opportunities exist in Asia-Pacific and Latin America, driven by increasing surgical procedures.
• Product Innovation: Development of preservative-free and combination therapies can sustain premium pricing and patient adherence.
• Regulatory and Pricing Strategies: Navigating diverse regulatory frameworks and reimbursement policies is critical for market continuity.
• Digital Transformation: Tele-ophthalmology and data analytics can optimize market access and operational efficiencies.

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FAQs

1. How does patent expiration generally impact ACULAR’s market share?
Patent expiration opens the door for generic manufacturers to produce cost-effective alternatives, usually leading to substantial price reductions and a decrease in brand-specific market share unless the original manufacturer innovates or differentiates.

2. What are the primary competitors to ACULAR in the ophthalmic NSAID segment?
Major competitors include bromfenac-based drugs (Bromsite), nepafenac formulations (Nevanac, I.instill), and newer combination medications that target post-operative ocular pain and inflammation.

3. Are there ongoing innovations that could extend ACULAR’s market longevity?
Yes, preservative-free formulations, sustained-release delivery systems, and combination therapies are under development, aimed at improving efficacy, safety, and patient adherence.

4. Which regional markets are expected to drive future growth for ACULAR?
The Asia-Pacific region, notably China and India, offers significant growth potential due to expanding ophthalmic surgery volumes and improving healthcare infrastructure.

5. How has COVID-19 affected the sales of ACULAR?
The pandemic caused a temporary decline in elective ocular surgeries, leading to reduced demand. However, as healthcare systems recover, procedural volumes are rebounding, stabilizing sales trajectories.

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References

1. [1] Market data on ophthalmic NSAIDs, Ophthalmology Times, 2022.
2. [2] Regulatory filings for ketorolac ophthalmic formulations, FDA and EMA databases, 2023.
3. [3] Industry analysis reports on generic drug market dynamics, IQVIA, 2022.
4. [4] Patent landscape for ophthalmic NSAIDs, World Intellectual Property Organization, 2023.
5. [5] Emerging trends in ophthalmic drug delivery, Journal of Ophthalmology, 2021.