ACULAR Drug Patent Profile

When do Acular patents expire, and when can generic versions of Acular launch?

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-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

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

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					Y
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No

International Patents for ACULAR

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

Country	Patent Number	Title	Estimated Expiration
Germany	3310079
Denmark	479980
Finland	884160
Japan	S6254792
Austria	364844
South Africa	7704238

Supplementary Protection Certificates for ACULAR

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	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	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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730

ACULAR Investment Scenario and Fundamentals Analysis

Last updated: February 3, 2026

Overview

ACULAR (generic: ketorolac ophthalmic), a non-steroidal anti-inflammatory drug (NSAID), is used for short-term management of eye pain and inflammation following ocular surgery or injury. Marketed predominantly by Allergan (a division of AbbVie), ACULAR has maintained steady sales but faces competitive pressures and patent challenges.

Market Landscape

• Global Ophthalmic NSAID Market: Valued at approximately $1.2 billion in 2022, with expected compound annual growth rate (CAGR) near 4.5% through 2030 (Grand View Research).
• Key Competitors: Bromfenac-based drugs (e.g., BromSite), nepafenac (Nevanac), and other NSAID formulations.
• Regulatory Environment: Patent exclusivity has expired in key markets like the U.S., increasing generic competition.

Sales and Revenue Dynamics

• Historical Sales: ACULAR generated approximately $300 million annually in the U.S. pre-patent expiry, with international sales adding $50 million.
• Post-Patent Expiry Impact: Market penetration by generics led to a decline in branded sales to $150 million by 2022.
• Pricing Trends: Branded ACULAR's average wholesale price (AWP) has declined by ~35% since patent expiry (IQVIA).

Patents and Intellectual Property

• Patent Status: The original composition patent expired in 2014. Current patent protections around formulations and delivery systems expired or are under challenge.
• Legal Actions: Litigation and patent challenges have opened pathways for generics. Patent litigation outcomes remain uncertain, influencing market share stability.

Pipeline and R&D

• Formulation Improvements: Few advanced formulations in late R&D stages aimed at prolonging exclusivity.
• New Indications: No significant pipeline updates suggesting new approved indications.

Financial Fundamentals

• Profitability: Branded ACULAR had gross margins above 70%. Generic competition decreased margins to below 50%.
• Cost Structure: Manufacturing costs around $1 per unit; high compliance and regulatory costs persist.
• Revenue Streams: Predominantly from U.S. sales, with international markets contributing marginally. Dependence on a few key markets increases risk.

Regulatory and Policy Risks

• Increased scrutiny of ophthalmic drugs by regulatory agencies.
• Subsequent patent challenges or generic entries could further erode profitability.
• Price controls, especially in European and Asian markets, could limit revenue growth.

Investment Risks and Opportunities

Risks:

• Continued loss of market share to generics.
• Regulatory delays or restrictions.
• Attrition of product relevance due to competitive innovations.

Opportunities:

• Potential for niche market preservation via unique formulations.
• Expansion into emerging markets with relatively lenient patent regimes.
• Investment in pipeline or new delivery systems for ocular NSAIDs.

Valuation Perspectives

• Current Valuation: Market cap of Allergan (prior to acquisition): approximately $60 billion; specific to ACULAR, revenue contribution is minor (~0.5–1% of total).
• Future Outlook: No substantial growth anticipated unless new patents or formulations are secured.

Summary

ACULAR remains a mature, commoditized asset within ophthalmic anti-inflammatory therapies. Its revenue trajectory depends on patent litigation outcomes, market share retention, and competitive dynamics. The drug's fundamental value is eroded by patent expiry and generic competition, but specific niche applications could sustain limited profitability.

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Key Takeaways

• ACULAR faces substantial challenges from generic competition post-2014 patent expiration.
• Market share has declined by roughly 50% since generic entry, affecting profitability.
• Limited pipeline or reformulation activity reduces future growth potential.
• Opportunities exist in emerging markets or niche indications but are limited.
• Investors should weigh revenue erosion risks against potential strategic licensing or niche market stability.

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FAQs

1. How long is the patent exclusivity for branded ACULAR?
   The original composition patent expired in 2014; additional patents around formulations or delivery systems have also expired or been challenged.

2. What has been the trend in ACULAR sales since patent expiry?
   Sales declined from approximately $300 million annually pre-patent expiry to about $150 million in 2022 due to generic market penetration.

3. Are there ongoing patent litigations for ACULAR?
   Some patent challenges and litigation are ongoing, but their outcomes remain uncertain, impacting future revenues.

4. What are the primary competitive threats?
   Generic ketorolac products and alternative NSAID formulations such as bromfenac and nepafenac.

5. Is there any pipeline activity for ACULAR?
   Limited pipeline activity exists; no new indications or formulations are in advanced development stages.

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Sources

1. Grand View Research. “Ophthalmic NSAIDs Market Size, Trends & Forecast” (2022).
2. IQVIA. “Pharmaceutical Price Data and Market Trends” (2022).
3. U.S. Patent Office. Patent filings and expirations related to ACULAR.
4. Allergan Annual Reports. Revenue breakdowns and pipeline updates (2018–2022).
5. MarketWatch. “Generic drug penetration and market share analysis” (2022).