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 are eight patents 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-six 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:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	23
Patent Applications:	4,893
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 four 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	AT	RX	Yes	Yes	9,216,167
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,377,982*PED				Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,648,107		Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,541,463*PED				Y
Abbvie	ACULAR LS	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	021528-001	May 30, 2003	AT	RX	Yes	Yes	8,906,950

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	9,216,167
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	8,906,950

International Patents for ACULAR LS

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0390071
Australia	626798
Hungary	210610
European Patent Office	0306984	PRESERVATIVE SYSTEM FOR OPHTALMIC FORMULATIONS
South Africa	8806757

Supplementary Protection Certificates for ACULAR LS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; 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
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	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

ACULAR LS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACULAR LS

Introduction

ACULAR LS, a ketorolac tromethamine ophthalmic solution, is a non-steroidal anti-inflammatory drug (NSAID) widely used in the treatment of ocular pain, inflammation, and other eye conditions. Here, we delve into the market dynamics and financial trajectory of ACULAR LS, highlighting its performance, market trends, and future outlook.

Market Position and Demand

ACULAR LS has established itself as a leading product in the ophthalmic drugs market. It is the number-one prescribed non-steroidal anti-inflammatory by U.S. ophthalmologists, indicating strong demand and market acceptance[2][5].

Historical Financial Performance

Historically, ACULAR LS has contributed significantly to the financial performance of its parent company, Allergan. In the early 2000s, the eye care pharmaceuticals segment, which includes ACULAR LS, saw steady growth. For instance, in 2003, the net sales from eye care pharmaceuticals were $999.5 million, with ACULAR LS being a key contributor to this figure[5].

Revenue Trends

The revenue from ACULAR LS has been part of the broader specialty pharmaceuticals segment of Allergan. Here are some key financial highlights:

• In 2003, the eye care pharmaceuticals segment, which includes ACULAR LS, generated $999.5 million in net sales[5].
• By 2007, this segment had grown to $1,776.5 million, with ACULAR LS remaining a significant product within this category[2].

Market Growth Drivers

Several factors have driven the market success of ACULAR LS:

• Increasing Prevalence of Ocular Conditions: The growing aging population and higher prevalence of ocular conditions such as cataracts, glaucoma, and dry eye syndrome have increased the demand for ophthalmic drugs like ACULAR LS[4].
• Technological Advancements: Continuous advancements in medical technology and diagnostic tools have enhanced the treatment and management of ocular pain and inflammation, further boosting the market for ACULAR LS[4].
• Regulatory Approvals: The optimized formulation of ACULAR LS, approved for reducing pain, burning, and stinging associated with ocular surgery, has been a significant factor in its market success[5].

Competitive Landscape

ACULAR LS operates in a competitive ophthalmic drugs market. Here are some key competitors and market dynamics:

• Market Share: ACULAR LS has maintained a strong market share among NSAIDs prescribed by ophthalmologists. For example, in 2007, it was the number-two NSAID prescribed by ophthalmologists, closely following other products like Acular[3].
• Competitive Products: Other products like Xibrom (bromfenac ophthalmic solution) and Istalol (timolol maleate ophthalmic solution) also compete in the same market space, but ACULAR LS has managed to retain its market position due to its efficacy and safety profile[3].

Future Outlook

The future outlook for ACULAR LS is promising, driven by several factors:

• Growing Ophthalmic Drugs Market: The global ophthalmic drugs market is projected to grow at a CAGR of 7.4% from 2024 to 2030, reaching USD 62.55 billion by 2030. This growth is expected to benefit ACULAR LS and other ophthalmic drugs[1].
• Increasing Demand: The acute ocular pain market, which includes products like ACULAR LS, is expected to grow at a CAGR of 8.93% from 2024 to 2031, driven by an aging population and technological advancements[4].

Regional Performance

The performance of ACULAR LS varies across different regions:

• North America: This region has been a significant market for ACULAR LS, given its high prescription rates and strong healthcare infrastructure[1].
• Europe: The European market is also expected to grow significantly, driven by increasing consumer awareness and regulatory support from bodies like the European Medicines Agency[1].

Key Takeaways

• Market Leadership: ACULAR LS is a leading non-steroidal anti-inflammatory ophthalmic solution.
• Historical Financial Performance: It has contributed significantly to the financial performance of Allergan.
• Growth Drivers: Increasing prevalence of ocular conditions, technological advancements, and favorable regulatory frameworks drive its market success.
• Competitive Landscape: ACULAR LS competes with other ophthalmic drugs but retains a strong market position.
• Future Outlook: The product is expected to benefit from the growing ophthalmic drugs market and increasing demand for acute ocular pain treatments.

FAQs

Q: What is ACULAR LS used for? A: ACULAR LS is used to reduce pain, burning, and stinging associated with ocular surgery and other eye conditions.

Q: How does ACULAR LS compare to other NSAIDs in the market? A: ACULAR LS is the number-one prescribed non-steroidal anti-inflammatory by U.S. ophthalmologists and holds a strong market share among NSAIDs.

Q: What are the key drivers of the market growth for ACULAR LS? A: The key drivers include the increasing prevalence of ocular conditions, technological advancements, and favorable regulatory frameworks.

Q: What is the projected growth rate of the ophthalmic drugs market? A: The global ophthalmic drugs market is projected to grow at a CAGR of 7.4% from 2024 to 2030.

Q: Which regions are expected to drive the growth of ACULAR LS in the future? A: North America and Europe are expected to be significant markets, with Asia-Pacific also showing potential due to its large patient population and growing healthcare infrastructure.

Sources

1. Straits Research: Ophthalmic Drugs Market Size to Grow at a CAGR of 7.4% by 2030
2. Allergan Annual Report 2007: Product net sales and financial highlights
3. ISTA Q3 07 Fact Sheet: Financial Highlights and product performance
4. MarketsandData: Acute Ocular Pain Market, Companies, Market Trends 2031
5. Allergan Annual Report 2003: Financial overview and product sales