ACULAR PRESERVATIVE FREE Drug Patent Profile

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

Acular Preservative Free is a drug marketed by Allergan and is included in one NDA.

The generic ingredient in ACULAR PRESERVATIVE FREE is ketorolac tromethamine. 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 Preservative Free

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

Summary for ACULAR PRESERVATIVE FREE

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997		DISCN	No	No

International Patents for ACULAR PRESERVATIVE FREE

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

Country	Patent Number	Title	Estimated Expiration
Australia	1265183
Australia	568072
Germany	3310079
Italy	1162842	COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE
Italy	8367315
Japan	H047324
Japan	S58172314	USE OF PYRROLOPYROLE FOR EYE DISEASE TREATMENT

Supplementary Protection Certificates for ACULAR PRESERVATIVE FREE

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	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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, 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	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

Last updated: February 3, 2026

What Is the Market and Investment Potential for ACULAR PRESERVATIVE FREE?

ACULAR PRESERVATIVE FREE (generic: ketorolac ophthalmic solution) targets ocular inflammation and allergic conjunctivitis, with a focus on preservative-free formulations designed for sensitive eyes. The global ophthalmic drug market reached $16.4 billion in 2022, with anti-inflammatory agents representing a significant segment due to increasing ocular disease prevalence and patient preference for preservative-free options.

The drug is currently marketed primarily in the U.S., with expanding opportunities in Europe and Asia. Its lifecycle status, patent protection, and competitive landscape influence its investment prospects. The trend toward preservative-free formulations and rising incidence of ocular conditions support sustained demand growth.

How Does the Product Position and Patent Status Impact Investment?

ACULAR PRESERVATIVE FREE operates in a competitive environment with established branded products like Allergan's AK-PREZ, along with generics. Patents for ketorolac formulations generally expire within 10-15 years of market launch, depending on jurisdiction. The expiration of exclusivity rights would permit generic competitors, reducing market share and price premiums.

The product's patent expiry date, current patent protections, and exclusivity status define the window for premium pricing and market share control. If recent patents are still active, the product maintains high margins. Once patent protections lapse, the entry of generics can erode profitability.

What Is the Scientific and Regulatory Landscape?

The drug's approval is governed by agencies like the FDA (U.S.) and EMA (Europe). The preservative-free formulation involves specific manufacturing standards to prevent contamination, which increases production costs but improves safety, especially for sensitive patients.

Recent regulatory trends favor preservative-free formulations, reducing barriers for approval. The U.S. FDA approved ACULAR Preservative-Free for ocular allergy in 1998, with subsequent approvals in other regions. The label includes indication-specific safety and efficacy data, influencing physician prescribing behavior.

How Do Market Trends Affect Growth and Investment?

The rising prevalence of dry eye syndrome, allergic conjunctivitis, and ocular surgeries contributes to steady demand for anti-inflammatory ophthalmics. Ageing populations and increased screen time elevate the incidence of ocular conditions requiring anti-inflammatory therapy.

Patients favor preservative-free drops due to lower risk of ocular surface toxicity, boosting demand for formulations like ACULAR Preservative Free. The COVID-19 pandemic heightened awareness of ocular health, encouraging more frequent use of eye drops and driving market growth.

Growth projections estimate a compound annual growth rate (CAGR) of 4-6% over the next five years for the ophthalmic anti-inflammatory segment, benefitting established products with differentiated features such as preservative-free formulations.

What Are the Risks and Challenges?

Key risks include patent expiration, which invites generic competition leading to price erosion. Market penetration may be limited if competitor drugs gain approval or if physicians prefer other anti-inflammatory agents with different mechanisms or dosing regimens.

Manufacturing complexities and costs for preservative-free formulations could impact margins. Regulatory changes favoring newer formulations or alternative therapies may reduce demand for existing products. Additionally, side effects like topical irritation or systemic absorption concerns could affect prescribing rates.

What Do Financial and Performance Data Say?

While specific financial data for ACULAR Preservative Free are not publicly disclosed, the broader class of ophthalmic NSAIDs shows consistent revenue growth. For example, Allergan's ophthalmic drugs generated over $1 billion annually before acquisition by AbbVie.

Pricing premium for preservative-free versions ranges from 10% to 20% higher than preserved formulations. Volume growth depends on physician adoption, patient preference, and insurance coverage policies. Competitive pressure influences pricing and market share dynamics.

Investment Recommendations and Short-term Outlook

Investment opportunities hinge on patent lifecycle status and regional regulatory approval progress. Companies with rights to ACULAR Preservative Free can benefit from increasing demand for preservative-free eye drops in developed markets.

Strategic partnerships and licensing agreements may enhance market reach. In the absence of patent protection, focus shifts toward generic competition and cost competitiveness.

Key Takeaways

ACULAR Preservative Free benefits from a growing ocular disease market and patient preference shifts toward preservative-free formulations. Its revenue potential depends heavily on patent protection status. Market growth is driven by demographic trends and increased ocular health awareness, but competitive pressures from generics, manufacturing costs, and regulatory changes pose risks.

Investors should monitor patent expiration dates, regulation developments, and regional market expansion plans to determine long-term viability.

5 FAQs

1. When will ACULAR Preservative Free lose patent protection?
Patent expiry in critical markets is expected between 2025 and 2030, depending on jurisdiction. Specific patent timelines should be verified for each region.

2. What are the main competitors?
Branded competitors include AK-PREZ (Allergan), along with other generic ketorolac formulations. New anti-inflammatory drugs and alternative therapies also form competition.

3. How does pricing compare between preserved and preservative-free formulations?
Preservative-free versions typically command a 10-20% higher price due to manufacturing standards and patient preference.

4. What regulatory hurdles could affect market growth?
Changes in safety requirements, approval of alternative therapies, or new formulations could impact market share of existing preservative-free products.

5. What is the outlook for regional expansion?
Europe and Asia represent growth opportunities, especially as regulatory pathways favor preservative-free ophthalmic drugs and regional disease burdens increase.

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Sources:

1. Grand View Research, Ophthalmic Drugs Market Analysis (2022).
2. FDA Drug Database, Approval history for ketorolac ophthalmic solutions.
3. MarketWatch, Corporate earnings reports of leading ophthalmic drug manufacturers.
4. IQVIA, Global ophthalmic drug sales data.
5. Recent patents and regulatory filings for ACULAR Preservative Free.