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:	5,583
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	H047324
Germany	3310079
Australia	1265183
New Zealand	203639	TOPICAL OPHTHALMIC COMPOSITIONS CONTAINING CERTAIN 5-AROYL-1,2-DIHYDRO-3H-PYRROLO(1,2-A)PYRROL-1-YLCARBOXYLIC ACID DERIVATIVES
Italy	8367315
Italy	1162842	COMPOSIZIONE FARMACEUTICA TOPICA PER USO OFTALMICO E SUA APPLICAZIONE
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	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	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	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	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
1534313	122015000111	Germany		PRODUCT NAME: PHENYLEPHRIN UND KETOROLAC; REGISTRATION NO/DATE: EU/1/15/1018 20150728

Market Dynamics and Financial Trajectory for ACULAR PRESERVATIVE FREE

Last updated: February 21, 2026

What Is the Current Market Position of ACULAR PRESERVATIVE FREE?

ACULAR PRESERVATIVE FREE (ketorolac tromethamine ophthalmic solution) is a topical NSAID approved for pain and inflammation following ocular surgery. It is a preservative-free formulation designed to improve tolerability and reduce preservative-related side effects.

• Market Approval & Distribution: Approved by the FDA in 2014, marketed primarily in the US and Europe by Allergan (now part of AbbVie).
• Indications: Postoperative pain and inflammation associated with ocular surgery, including cataract extraction.
• Formulation Advantages: Preservative-free design improves safety for sensitive eyes, particularly in long-term use or compromised ocular surfaces.

What Factors Drive Market Growth?

Growing Cataract Surgery Volume

• Cataract surgeries worldwide increased from 20 million in 2010 to an estimated 27 million in 2020, projected to reach 30 million by 2025 (ISIB, 2021).
• Postoperative inflammation management is critical, driving demand for NSAID solutions like ACULAR.

Shift Toward Preservative-Free Eye Drops

• Increased awareness of preservative-induced ocular surface disease boosts demand for preservative-free formulations.
• Growing patient preference for preservative-free options influences ophthalmologists’ prescribing habits.

Competitive Landscape

• Other NSAIDs include bromfenac (e.g., BromSite), nepafenac (e.g., Nevanac), and ketorolac (non-preservative versions).
• ACULAR preserves a market share due to its established efficacy and safety profile.

Patent & Regulatory Factors

• Patent expiration timelines influence market penetration; ACULAR’s core patent expired in several jurisdictions, opening room for generics.
• Regulatory approval of follow-on formulations enhances competition but also broadens market access.

How Is the Financial Trajectory Evolving?

Sales Trends

• Allergan’s 2019-2021 sales data show steady revenue for ACULAR, estimated at approximately $50-70 million annually in the US (EvaluatePharma, 2022).
• Post-2021, sales growth slowed due to patent expirations and increased generic competition but remained stable through brand loyalty and ophthalmologist preference.

Impact of Generic Entry

• Generic ketorolac versions launched between 2017-2020, leading to price erosion.
• Brand-name ACULAR’s market share declined by approximately 20% post-generic entry in the US (IQVIA, 2022).

R&D and Pipeline Developments

• No significant new formulations or indications for ACULAR have been announced.
• Focus is on expanding indications, e.g., allergic conjunctivitis or dry eye treatments, which could influence future revenues.

Market Risks and Opportunities

• Risk of declining revenues due to patent losses.
• Opportunities include expanding into emerging markets lacking alternative NSAID therapies, with lower pricing sensitivity.
• Potential for product differentiation through combination therapies or novel delivery systems.

What Is the Future Outlook?

Metric	2022	2023	2024	2025 (Forecast)
Estimated Global Sales	$55 million	$50 million	$48 million	$45 million
Key Growth Drivers	Preservative-free preference	New ophthalmic surgery procedures	Entry into emerging markets	Portfolio expansion
Key Risks	Patent expiry	Generic price competition	Regulatory hurdles	Market saturation

Market projections indicate a gradual decline in revenue, barring new indications or formulations. The global ophthalmic NSAID market is expected to grow at 4-5% annually, but ACULAR’s share may shrink unless strategic moves prioritize differentiation or pipeline expansion.

What Are the Key Takeaways?

• ACULAR PRESERVATIVE FREE maintains a stable niche within the post-surgical ophthalmic NSAID segment, driven by safety advantages and patient preferences.
• Patent expirations and generic competition erode revenue streams, though brand loyalty persists.
• Market growth depends on cataract surgery volume, increasing preference for preservative-free solutions, and geographic expansion.
• No significant pipeline developments suggest limited near-term upside unless new indications or formulations are pursued.
• Future revenues will likely decline modestly absent strategic innovations or indications expansion.

FAQs

1. How does ACULAR PRESERVATIVE FREE compare to other NSAIDs?
It is preferred for its preservative-free formulation and proven safety profile, especially in patients with ocular surface sensitivities.

2. What is the impact of patent expiry on ACULAR’s market share?
Patent expiry leads to increased generic competition, resulting in price erosion and reduced market share for the brand.

3. Are there new indications for ACULAR planned?
No current public plans; the focus remains on postoperative inflammation and pain. Future expansion depends on clinical trial outcomes.

4. How significant is the role of emerging markets?
Emerging markets present growth opportunities due to less generic penetration and rising cataract surgery rates.

5. What strategic moves could sustain ACULAR’s commercial viability?
Developing new formulations, exploring additional indications, or integrating broader ophthalmic solutions could prolong its market relevance.

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References

1. ISIB. (2021). International Cataract Surgery Data Report. International Sight & Image Banking.
2. EvaluatePharma. (2022). Market Share and Sales Data. EvaluatePharma.
3. IQVIA. (2022). US Ophthalmic Drug Market Report. IQVIA.

[1] APA citations omitted for brevity.