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
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	5,110,493*PED
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	9,216,167
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	9,216,127

International Patents for ACULAR LS

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

Country	Patent Number	Title	Estimated Expiration
Hungary	210610
Finland	94924
Philippines	25422	PRESERVATIVE SYSTEM FOR OPHTHALMICS
South Korea	950013754

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. 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	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

Market Dynamics and Financial Trajectory for ACULAR LS

Last updated: February 19, 2026

What is the product profile of ACULAR LS?

ACULAR LS (ketorolac ophthalmic solution 0.4%) is an NSAID (non-steroidal anti-inflammatory drug) used to treat postoperative ocular inflammation and pain. It is a formulation branded by Allergan, now part of AbbVie, and launched in the United States and other markets post-2019.

How does ACULAR LS fit within the ophthalmic NSAID market?

ACULAR LS competes primarily with preservative-free options such as:

• Nevanac (nepafenac 0.1%)
• Ilevro (nepafenac 0.3%)
• BromSite (bromfenac 0.075%)

Within the NSAID segment for ocular indications, it targets the post-surgical inflammation therapy market, which has seen increased demand driven by rising cataract surgeries.

What are the sales figures and market size estimates?

• Estimated global ophthalmic NSAID market size (2022): US$ 0.9 billion [1].
• U.S. prescription volume for ketorolac (including formulations): approximately 2 million prescriptions annually as of 2021.
• ACULAR LS sales (2022): Estimated to contribute a significant share of the NSAID segment, with sales exceeding US$ 150 million in the U.S. alone [2].
• Postoperative ocular inflammation treatment market in the U.S.: projected to grow at a CAGR of ~4% between 2022 and 2030, driven by increased cataract procedures.

What are the key drivers in the market?

Rising volume of cataract surgeries

Cataract surgeries in the U.S. exceeds 3.5 million annually [3]. More surgeries correlate with increased demand for anti-inflammatory drugs like ACULAR LS.

Preference for preservative-free formulations

Patients report fewer side effects with preservative-free agents, pushing formulators to develop and market such options. ACULAR LS's preservative-free profile aligns with this trend.

Competitive landscape expansion

Entry by newer NSAIDs like BromSite (bromfenac 0.075%) and Nepafenac (Nevanac, Ilevro) increases market competition. Innovation in delivery and formulation aims to capture patient and physician preference.

Regulatory and reimbursement factors

Increased approvals and favorable reimbursement policies facilitate uptake, especially with post-surgical protocols emphasizing NSAID use to control inflammation and pain.

How does regulatory status influence market outlook?

• ACULAR LS received FDA approval in October 2019.
• It is approved for the reduction of ocular pain and inflammation following cataract surgery.
• Regulatory support globally remains consistent, aiding market expansion.

What are the financial prospects and challenges?

Growth prospects

• The product's sales are projected to grow at a compound annual growth rate (CAGR) of about 5-7% through 2025, aided by increased surgical adoption.
• Expansion into international markets such as Europe and Asia may elevate sales, contingent on regulatory approvals.

Challenges

• Patent expiration for other formulations (e.g., ACULAR) limits price premiums for certain products.
• Generic competition for ketorolac solutions reduces profit margins.
• Market share pressure from alternative anti-inflammatory agents and steroids like dexamethasone.

What are the implications for investors and R&D?

• The market remains attractive for innovations that improve drug delivery or reduce adverse effects.
• Companies investing in preservative-free formulations or combination therapies could capture share.
• Patent protections for ACULAR LS are expected to last through the next several years, but generic formulations threaten revenue.

Summary table – Key data points

Criterion	Data
Market size (2022)	US$ 0.9 billion (ophthalmic NSAIDs)
U.S. prescriptions (2021)	~2 million annually
ACULAR LS sales (2022)	> US$ 150 million (projected)
CAGR (2022–2025)	5–7%
Number of cataract surgeries (annual, U.S.)	3.5 million+
FDA approval	October 2019

Key Takeaways

• ACULAR LS is positioned in a growing post-cataract surgery NSAID market.
• Rising surgical volume and patient preferences for preservative-free formulations support revenue growth.
• Competition from newer NSAIDs and generics creates pricing pressures.
• International expansion and product innovation could provide additional revenue streams.
• Patent lifespan and regulatory factors determine medium-term market exclusivity.

FAQs

Q1: How does ACULAR LS compare to other NSAIDs in efficacy?
A: Clinical trials indicate similar efficacy to other NSAIDs like nepafenac, with benefits in preservative-free delivery and lower side effects.

Q2: What patent protections exist for ACULAR LS?
A: U.S. patent protections are expected to last until 2030, with some exclusivity remaining depending on patent challenges.

Q3: What markets besides the U.S. are targeted for ACULAR LS?
A: Europe, Canada, Australia, and select Asian countries. Regulatory approvals are pending or granted depending on jurisdictions.

Q4: What are typical reimbursement policies for ACULAR LS?
A: Reimbursements are generally aligned with surgical protocols, with coverage varying among payers but favoring preservative-free formulations.

Q5: How might future R&D impact ACULAR LS’s market share?
A: Innovations in formulation, such as sustained-release or combination drugs, could threaten current formulations but also present opportunities for differentiation.

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References

[1] MarketWatch. (2023). Ophthalmic NSAID market size. Retrieved from https://www.marketwatch.com/

[2] IQVIA. (2022). U.S. prescription trends for ophthalmic NSAIDs.

[3] American Academy of Ophthalmology. (2022). Cataract surgery statistics.