ACULAR PRESERVATIVE FREE Drug Patent Profile

When do Acular Preservative Free patents expire, and what generic alternatives are available?

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. 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 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
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	4,442
DailyMed Link:	ACULAR PRESERVATIVE FREE at DailyMed

Recent Clinical Trials for ACULAR PRESERVATIVE FREE

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

Sponsor	Phase
Fundação Altino Ventura	Phase 2/Phase 3

See all ACULAR PRESERVATIVE FREE clinical trials

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

Expired US Patents for ACULAR PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	ACULAR PRESERVATIVE FREE	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	020811-001	Nov 3, 1997	4,454,151*PED

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
Japan	S58172314	USE OF PYRROLOPYROLE FOR EYE DISEASE TREATMENT
Australia	1265183
Japan	H047324
Germany	3310079
Italy	1162842	COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE
Italy	8367315

Supplementary Protection Certificates for ACULAR PRESERVATIVE FREE

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	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	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	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728
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 ACULAR Preservative-Free

Last updated: July 31, 2025

---

Introduction

ACULAR Preservative-Free (known generically as ketorolac tromethamine ophthalmic solution) represents a significant niche within the ophthalmic pharmaceutical landscape. With its application primarily in the treatment of postoperative inflammation and pain associated with ocular surgery, particularly cataract procedures, the drug’s market performance hinges on regulatory, clinical, and competitive factors. Analyzing its market dynamics and financial trajectory offers insight into the broader ophthalmic drug sector and emerging trends that could influence growth and profitability.

---

Market Overview and Demand Drivers

1. Therapeutic Indications and Clinical Preference

ACULAR Preservative-Free is favored for its effective anti-inflammatory and analgesic properties, especially post-cataract surgery. Its preservative-free formulation offers enhanced safety profiles compared to preserved counterparts, notably reducing risks of ocular surface toxicity and preservative-induced dry eye syndrome (Stern et al., 2013). Surgeons increasingly prefer preservative-free options, aligning with broader patient safety and comfort priorities, which boosts demand.

2. Growing Cataract Surgery Market

Globally, cataract surgeries are among the most common ophthalmic procedures, with over 20 million procedures annually (WHO, 2020). The rising aging population and technological advancements in surgical techniques catalyze the expansion of the surgical pipeline. Consequently, demand for anti-inflammatory and analgesic ophthalmic solutions like ACULAR Preservative-Free is poised for growth, underpinning its market footprint.

3. Patient Preferences and Regulatory Trends

Patients show growing preference for preservative-free ophthalmic medications due to tolerability improvements. Regulatory agencies like the FDA and EMA have increasingly recommended or mandated preservative-free formulations for intraocular drugs, especially for long-term use. This trend favors the adoption of ACULAR Preservative-Free in clinical settings, further solidifying its market position.

---

Market Dynamics

1. Competitive Landscape

ACULAR Preservative-Free competes primarily against preserved ketorolac formulations and other NSAID-based ocular therapies such as nepafenac (Nevanac), bromfenac (Prolensa), and diclofenac (Voltaren). The increasing prominence of preservative-free offerings by major manufacturers like Alcon, Allergan (AbbVie), and Bausch + Lomb intensifies competition, constraining pricing power but also expanding the segment.

2. Pricing, Reimbursement, and Market Access

Pricing strategies for preservative-free ophthalmic solutions tend to be higher than preserved versions, justified by manufacturing costs and safety advantages (IQVIA, 2022). Reimbursement policies are evolving to favor preservative-free options, especially where long-term safety is concerned. Favorable reimbursement enhances accessibility, supporting steady revenue streams.

3. Supply Chain and Manufacturing Considerations

The manufacturing of preservative-free ophthalmic solutions involves sophisticated aseptic processes and single-dose packaging, raising production costs. Enhanced regulatory scrutiny on manufacturing standards increases compliance costs but ensures product quality, critical for market trust.

4. Emerging Technologies and Pipeline Products

Innovations such as sustained-release formulations, novel NSAIDs, and targeted biologics threaten traditional NSAID products’ dominance. Nonetheless, preservative-free NSAID solutions like ACULAR maintain a competitive edge due to ease of administration and established safety profiles.

---

Financial Trajectory Projections

1. Revenue Trends

Historical data indicate that ophthalmic NSAIDs like ACULAR Preservative-Free have experienced moderate growth, driven by the expanding cataract surgery market. Between 2017 and 2022, the segment’s CAGR approximated 4-6% globally (MarketWatch, 2022). ACULAR's specific contribution benefits from the rise of preservative-free formulations, which account for an estimated 60% of the NSAID ophthalmic market.

2. Impact of Market Penetration and Brand Loyalty

ACULAR has established a strong brand presence via early adoption and extensive clinical validation. Its preservative-free variant’s penetration is anticipated to grow at a CAGR of 5-7% over the next five years, aided by increased ophthalmic surgery volumes and clinician preference shifts.

3. Pricing and Revenue Forecasts

Premium pricing for preservative-free formulations positions ACULAR Preservative-Free as a high-margin product. With anticipated sales volume increases, revenues could grow at an average annual rate of 4-6% over the next five years, contingent on regulatory approvals and competitive dynamics.

4. Regulatory and Patent Landscape

Patent expirations and biosimilar entries could pressure prices and margins. However, the complexity of manufacturing preservative-free solutions and regulatory hurdles serve as barriers to immediate biosimilar proliferation, supporting sustained revenue streams.

5. Market Entry and Expansion Opportunities

Potential expansion into emerging markets, driven by rising ophthalmic surgical rates and increasing healthcare infrastructure, offers additional revenue opportunities. Localized manufacturing and strategic partnerships could accelerate growth.

---

Key Challenges and Opportunities

Challenges

• Intense Competition: From other NSAID formulations and emerging biologic therapies.
• Pricing Pressures: Increasing commoditization could depress prices over time.
• Regulatory Risks: Stringent manufacturing and safety standards may escalate costs.
• Market Saturation: Limited incremental growth in mature markets without product innovation.

Opportunities

• Product Lifecycle Extension: Developing sustained-release formulations or combination therapies.
• Market Diversification: Expansion into inflammation management beyond cataract surgery.
• Technological Innovations: Using nanotechnology or bioengineering to improve drug delivery and efficacy.
• Post-Pandemic Growth: Increased surgical volumes as healthcare systems recover and adapt.

---

Conclusion

The market dynamics for ACULAR Preservative-Free are predominantly shaped by broader ophthalmic surgical trends, safety-centric patient preferences, regulatory shifts favoring preservative-free treatments, and competitive competitive pressures. Financially, the product is positioned for steady growth driven by increasing surgical volumes, brand recognition, and the premium pricing environment for preservative-free formulations. Longer-term success hinges on innovation, market expansion, and maintaining a competitive edge against generic and biosimilar entrants.

---

Key Takeaways

• The global ophthalmic NSAID market, especially preservative-free options like ACULAR Preservative-Free, is poised for consistent growth driven by the rise in cataract surgeries and shifting regulatory and patient preferences.
• Competitive forces and manufacturing complexities require continuous innovation and strategic positioning; product differentiation remains key.
• Revenue growth is expected to be sustainable through penetration in emerging markets, higher patient safety standards, and expanded ophthalmic indications.
• Regulatory trends prioritize preservative-free formulations, creating upward pricing and reimbursement opportunities.
• Strategic investments in technological advances and pipeline expansion can mitigate competitive threats and extend product lifecycle profitability.

---

FAQs

1. What factors drive the demand for preservative-free ophthalmic drugs like ACULAR Preservative-Free?
Demand is driven by safety concerns associated with preservatives, increasing preference among patients and clinicians, regulatory endorsement, and the rising number of ophthalmic surgeries worldwide.

2. How does ACULAR Preservative-Free compare to preserved NSAID formulations in terms of market share?
Preservative-free formulations are gaining market share due to their improved safety profile and healthcare provider preference, with estimates indicating that they constitute approximately 60% of the ophthalmic NSAID segment.

3. What are the key challenges affecting ACULAR Preservative-Free’s financial trajectory?
Key challenges include intense competition from biosimilars and other NSAID products, manufacturing costs, regulatory compliance, and market saturation in mature regions.

4. What emerging opportunities could enhance ACULAR Preservative-Free’s market potential?
Opportunities include developing sustained-release formulations, expanding into new indications, signing strategic partnerships in emerging markets, and leveraging technological innovations to improve drug delivery.

5. How might regulatory trends influence the future pricing and profitability of ACULAR Preservative-Free?
Regulatory policies favoring preservative-free formulations support premium pricing due to safety benefits, potentially enhancing profitability; however, evolving standards could also increase compliance costs.

---

References

1. Stern, M. E., et al. (2013). Preservative toxicity in ophthalmology. British Journal of Ophthalmology, 97(4), 464-468.
2. WHO. (2020). World report on vision. World Health Organization.
3. IQVIA. (2022). Global Ophthalmic Pharmaceuticals Market Report.
4. MarketWatch. (2022). Ophthalmic Pharmaceuticals Market Analysis and Forecast.