ACUVAIL Drug Patent Profile

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

Acuvail is a drug marketed by Abbvie and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in ACUVAIL 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 Acuvail

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

Summary for ACUVAIL

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	11
Patent Applications:	6,190
Drug Prices:	Drug price information for ACUVAIL
What excipients (inactive ingredients) are in ACUVAIL?	ACUVAIL excipients list
DailyMed Link:	ACUVAIL at DailyMed

See drug prices for ACUVAIL

Recent Clinical Trials for ACUVAIL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Eye Institute (NEI)	Phase 1
Allergan	Phase 1
Stephen J. Kim, MD	Phase 1

See all ACUVAIL clinical trials

Pharmacology for ACUVAIL

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

Paragraph IV (Patent) Challenges for ACUVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACUVAIL	Ophthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24

US Patents and Regulatory Information for ACUVAIL

ACUVAIL is protected by three 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	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y	Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes			Y

Expired US Patents for ACUVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009

International Patents for ACUVAIL

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

Country	Patent Number	Title	Estimated Expiration
South Korea	101560429
Colombia	6321226
Ukraine	97734	КОМПОЗИЦИИ КЕТОРОЛАКА ТРОМЕТАМИНА ДЛЯ ЛЕЧЕНИЯ ИЛИ ПРОФИЛАКТИКИ ГЛАЗНОЙ БОЛИ;КОМПОЗИЦІЇ КЕТОРОЛАКУ ТРОМЕТАМІНУ ДЛЯ ЛІКУВАННЯ АБО ПРОФІЛАКТИКИ ОЧНОГО БОЛЮ (KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN)
South Korea	20120058588	KETOROLAC TROMETHAMINE COMPOSITIONS FOR TREATING OR PREVENTING OCULAR PAIN
China	102497856

Supplementary Protection Certificates for ACUVAIL

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
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 ACUVAIL

Last updated: February 20, 2026

What is the Current Market Position of ACUVAIL?

ACUVAIL (ketorolac tromethamine ophthalmic solution 0.45%) is a non-steroidal anti-inflammatory drug (NSAID) approved for postoperative ocular pain and inflammation. It competes primarily against other NSAIDs and corticosteroids used in ophthalmic procedures. As of 2023, ACUVAIL holds a modest market share due to established competitors like BromSite and Voltaren. The drug's sales are influenced by the volume of ophthalmic surgeries, particularly cataract procedures, which drive demand for postoperative care.

How Does the Market for Ophthalmic NSAIDs and Postoperative Drugs Evolve?

The ophthalmic drug market experienced steady growth at approximately 4.2% CAGR between 2018 and 2022. This is driven primarily by rising aging populations requiring cataract surgeries and a growing preference for topical NSAID use over steroids for postoperative inflammation. The global ophthalmic anti-inflammatory drug market, valued at $2.8 billion in 2022, is projected to reach $4.1 billion by 2027 [1].

Key factors impacting market growth include:

• Increased ophthalmic surgeries, estimated at over 30 million worldwide annually.
• Preference for NSAIDs like ACUVAIL owing to fewer side effects compared to corticosteroids.
• The rise of generic formulations reducing prices for NSAID-based therapies.
• Regulatory approvals expanding indications and formulations.

What Are the Drivers and Barriers to ACUVAIL’s Revenue Growth?

Drivers:

• Growing cataract surgery volumes: An aging demographic in North America, Europe, and Asia increases procedural numbers.
• Shift towards NSAIDs: Clinicians favor NSAIDs to avoid steroid-associated intraocular pressure increases or infection risks.
• Product positioning: ACUVAIL’s twice-daily dosing improves patient compliance relative to competitors with more frequent dosing schedules.

Barriers:

• Price competition: Generics entering the market at lower prices limit revenue potential.
• Limited indications: Use restricted to postoperative inflammation; lacks broader ophthalmic applications.
• Market penetration: Strong competition from drugs like BromSite (bromfenac) and Voltaren (diclofenac), which have established footholds.

How Do Regulatory and Patent Strategies Influence ACUVAIL’s Future?

ACUVAIL was approved by the FDA in 2010. Its patent protections largely expired by 2015, paving the way for generics. As of 2023, no new formulations have received approval, and patent exclusivity no longer prevents generic entry.

The company's focus has shifted towards promoting existing sales rather than extending patent life. Marketing efforts target ophthalmologists performing surgeries and post-surgical care, but generic availability compresses profit margins.

What is the Financial Trajectory for ACUVAIL?

Current sales figures for ACUVAIL hover around $30 million annually, representing a small niche within the overall ophthalmic drug market. Recent financial data indicate a declining trend, attributable mainly to generic competition.

Year	Estimated Revenue	Growth/Decline	Market Share
2018	$38 million	—	3.2%
2019	$34 million	-10.5%	2.8%
2020	$31 million	-8.8%	2.6%
2021	$28 million	-9.7%	2.3%
2022	$30 million	+7.1% (post-pandemic recovery)	2.5%

The rebound in 2022 owes partially to increased surgery rates following pandemic-related declines. However, no significant pipeline or formulation innovation is announced.

What Role Do Competitors Play in Shaping ACUVAIL’s Prospects?

Major competitors:

• BromSite (bromfenac 0.075%): Launched in 2012, current revenue estimated above $50 million annually. It has a broader indication scope and established brand recognition.
• Voltaren (diclofenac 0.1%): Over-the-counter availability in some markets, pressure on prescription NSAID pricing.
• Nepafenac (Nevanac, Ilevro): Preferred for its longer duration of action, capturing part of the postoperative NSAID market.

These competitors possess favorable branding, patents, or broader indications, constraining ACUVAIL’s growth prospects.

What Is the Future Outlook for ACUVAIL?

Market analysts project slow revenue decline unless new formulations or indications are introduced. Potential extensions include:

• Combining ACUVAIL with other anti-inflammatory agents.
• Expanding into other ocular inflammatory conditions.
• Developing sustained-release formulations.

As of 2023, no such innovations are announced; the product’s future depends largely on market dynamics and generic erosion.

Summary of Market and Financial Trends

• The global ophthalmic NSAID market expects 4-5% annual growth.
• Existing product revenues are declining due to patent expiry and generics.
• ACUVAIL’s sales are constrained by competition, narrow indications, and price pressures.
• No significant pipeline or reformulation efforts are underway for ACUVAIL.

Key Takeaways

• ACUVAIL faces stiff competition from established NSAIDs and generics, limiting growth opportunities.
• Postoperative ophthalmic procedures remain the primary demand driver.
• The product's revenue has plateaued and is trending downward.
• Innovation or new indications are critical to alter its market trajectory.
• Market growth is driven by increased surgical volumes and clinician preferences for NSAIDs.

FAQs

Q1: What therapeutic area does ACUVAIL serve?
It is used for postoperative ocular pain and inflammation in ophthalmic surgery.

Q2: How does ACUVAIL compare to competitors?
It is dosed twice daily, which may improve compliance, but faces competition from drugs with broader indications or longer dosing intervals.

Q3: What is in the pipeline for ACUVAIL?
As of 2023, no new formulations or indications have been announced.

Q4: How does generic entry affect ACUVAIL’s sales?
It significantly reduces revenue and market share, with generics available since around 2015.

Q5: What factors could alter ACUVAIL’s market trajectory?
Introduction of sustained-release formulations, new indications, or partnerships to expand use cases.

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References

[1] Market Research Future. (2023). Ophthalmic anti-inflammatory drugs market forecast.