ACULAR Drug Patent Profile

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

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-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

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	23
Patent Applications:	7,086
Drug Prices:	Drug price information for ACULAR
What excipients (inactive ingredients) are in ACULAR?	ACULAR excipients list
DailyMed Link:	ACULAR at DailyMed

See drug prices for ACULAR

See drug sales revenues for ACULAR

Recent Clinical Trials for ACULAR

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

Sponsor	Phase
Emory University	Early Phase 1
University of Louisville	Phase 4
Arthroplasty Foundation, Inc.	Phase 4

See all ACULAR clinical trials

Pharmacology for ACULAR

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

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

Expired US Patents for ACULAR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACULAR	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	019700-001	Nov 9, 1992

International Patents for ACULAR

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

Country	Patent Number	Title	Estimated Expiration
Argentina	224997	METODO PARA PREPARAR 5-BENZOIL O 5-BENZOIL SUSTITUIDO DERIVADOS DE ACIDOS 1,2-DIHIDRO-3H-PIRROLO(1,2-A)PIRROL-1-CARBOXILICOS
Austria	363465
Austria	364844
Austria	369003
Austria	A402479
Austria	A509077

Supplementary Protection Certificates for ACULAR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	300784	Netherlands		PRODUCT NAME: KETOROLAC, OF HET TROMETAMOLZOUT ERVAN, EN FENYLEFRINE, OF HET HYDROCHLORIDEZOUT ERVAN; REGISTRATION NO/DATE: EU/1/15/1018 20150730
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

ACULAR (ketorolac tromethamine ophthalmic) market dynamics and financial trajectory: pricing, demand drivers, competition, and IP risk

Last updated: July 2, 2026

ACULAR (ketorolac tromethamine ophthalmic solution 0.5%) has a small-to-mid ophthalmic analgesic revenue pool but faces persistent erosion risk from (1) generic ketorolac ophthalmics, (2) competitive nonsteroidal anti-inflammatory drug (NSAID) ophthalmics, and (3) patent and exclusivity expiration timelines that constrain sustained premium pricing. Financial trajectory is typically driven by procedure volume (cataract surgery), channel stocking cycles in retail and ambulatory surgical centers, and payer or wholesaler preference for lowest net price generics.

What is ACULAR and which indications drive demand?

ACULAR is a topical ocular NSAID containing ketorolac tromethamine, used for pain and inflammation in the eye.

What clinical use cases are the market pull?

Primary demand is tied to:

• Post-operative pain and inflammation following cataract surgery
• Prophylaxis and treatment of ocular pain associated with intraocular surgery (label-dependent, product and jurisdiction specific)

How does the ophthalmic perioperative market behave?

Ophthalmic NSAID demand tends to track:

• Cataract surgery volumes (U.S. and major EU markets)
• Switch behavior among prescribers and surgery centers toward generics at the class level
• Brand substitution once a labeled alternative is treated as interchangeable at the wholesale level

How big is the ACULAR market versus ketorolac ophthalmic generics and competing NSAIDs?

The market for ketorolac ophthalmics is fragmented across:

• Branded ketorolac products (historically including ACULAR)
• Multiple generic ketorolac formulations and strengths
• Competing ophthalmic NSAIDs (other drug substances)

Who are the functional competitors?

Competitors are typically other topical ophthalmic NSAIDs used for similar perioperative pain/inflammation endpoints, such as:

• Nepafenac products
• Bromfenac products
• Diclofenac products
• Additional ketorolac-labeled generics depending on geography

Market structure: why revenue is compressed

For mature ophthalmic NSAIDs, revenue typically compresses because:

• Acute perioperative use limits loyalty
• Multiple formulary and substitution channels exist
• Prescribers often face no meaningful clinical differentiator that sustains premium pricing

What has ACULAR’s financial trajectory looked like historically?

ACULAR is a long-established ophthalmic product. In mature brands with well-penetrated generics, financial trajectory usually follows a pattern:

• Initial brand premium prior to generic entry
• Post-generic entry revenue decline driven by share loss to the lowest net price
• Stabilization at a smaller base if brand retains coverage for specific patient populations, prescriber habits, or supply contracts

Revenue drivers that can temporarily slow erosion

• Contracting or distribution agreements that extend brand presence
• Bundle purchasing tied to surgical center protocols
• Short-term supply constraints impacting generics (when supply disruptions occur)

Revenue headwinds

• Continued generic substitution in pharmacy channels
• Net price declines from wholesalers and PBMs
• Switching by surgery centers to alternative NSAIDs with favorable net pricing

When does ACULAR lose exclusivity, and what does that imply for pricing power?

ACULAR is not a late-cycle product. For market dynamics purposes, the key point for stakeholders is that ketorolac ophthalmics are widely available and treated as interchangeable within therapeutic class use. That structurally caps pricing power versus earlier development-stage brands.

What timing matters for financial planning?

For an incumbent brand, the market impact comes from:

• Generic launch dates of ketorolac ophthalmic competitors
• Expiration of any remaining brand-relevant exclusivities (if any exist in specific markets)
• Loss of label exclusivity tied to any later formulation or new-strength launch (if applicable)

Actionable market implication: once generic penetration is high, the financial model becomes net-price and volume-share driven rather than premium pricing driven.

What patents protect ACULAR and how strong is the patent estate?

For mature, widely genericized ophthalmic ketorolac products, the practical patent posture is usually:

• Core composition-of-matter and early method-of-use patents are long expired
• Remaining patent activity, if any, tends to be narrower around formulations, specific manufacturing methods, or later improvements

How does patent strength affect litigation and settlement risk?

When a patent estate is weak or mostly expired:

• Paragraph IV litigation is less likely to support long exclusivity for generics
• Settlements, if they occur, tend to be short and aimed at minor launch timing or labeling scope

IP risk lens for investors and licensors

• Primary risk: ongoing generic competition with rapid shelf-level substitution
• Secondary risk: any residual patent that can create temporary “hold” on a subset of generics
• Operational impact: marketers should optimize contracting and channel strategy rather than rely on long residual exclusivity

What is the Orange Book status of ACULAR?

ACULAR’s regulatory status in the U.S. market is typically consistent with a product whose active ingredient is widely genericized. That means:

• Orange Book entries generally show limited practical brand exclusivity remaining for most ketorolac ophthalmic strengths and dosage forms
• Generic competitors often hold ANDA approvals for ketorolac ophthalmic solutions

Market implication: Orange Book dynamics for mature ketorolac products usually translate into continued generic availability and persistent price competition.

What generic entry risks exist for ACULAR?

Given that ketorolac ophthalmic is a mature molecule with multiple generic suppliers, “generic entry” risk is mostly about:

• Additional ANDAs or strength/formulation-specific entries that broaden coverage
• Competitive intensity from new entrants if wholesalers switch to lower-cost supply
• Supply disruptions that can temporarily raise market share for a brand, followed by rapid normalization once supply stabilizes

What is the likely launch playbook for generics?

• Rapid substitution in outpatient pharmacies and surgical centers
• Price undercutting against brand net price
• Support through payer and wholesaler formulary mechanisms

What formulations are protected by ACULAR-related patents?

The formulation landscape is usually limited to:

• Specific drug product formulation attributes (buffering, viscosity, excipient systems)
• Manufacturing method claims
• Packaging and delivery system claims (if any)

Market implication: formulation IP, if it exists, typically affects narrow subsets of competitors rather than sustaining broad brand economics.

Which companies are challenging ACULAR?

For a widely genericized ketorolac ophthalmic product, challengers generally include:

• Multiple ANDA filers producing ketorolac ophthalmic solutions
• Firms that expand capacity for common ophthalmic NSAIDs

Commercial implication: competition is distributed, so the brand faces share pressure from several directions rather than a single dominant opponent.

What patent litigation affects ACULAR?

For mature ophthalmic products, litigation tends to be:

• Historic (core molecule dates)
• Narrow residual disputes tied to later improvements
• Occasionally driven by formulation or manufacturing process claims

Market implication: unless a late-cycle patent is active, litigation rarely reverses long-term net price compression.

How does ACULAR compare with competing ophthalmic NSAIDs (nepafenac, bromfenac, diclofenac)?

Ketorolac ophthalmics compete on:

• Clinical equivalence across common perioperative NSAID endpoints
• Dosing convenience (frequency)
• Net price and formulary preference
• Prescriber familiarity

Practical differentiation points that affect purchase behavior

• Dosing regimen burden for surgeons and patients
• Formulary placement by PBMs and surgery center pharmacy committees
• Contracting and tendering in hospital and ambulatory settings

Market implication: competitive performance is frequently decided by net price and formulary status more than by molecule-level efficacy.

How do FDA regulatory and manufacturing factors influence ACULAR revenues?

For branded ophthalmic solutions, revenue stability is influenced by:

• Manufacturing capacity and supply continuity
• Field actions and stability/packaging compliance
• Generic manufacturing scale that drives price erosion

Channel-level factors

• Distribution leverage by major wholesalers
• Tendering behavior for surgical centers
• Purchase agreements tied to seasonal cataract surgery throughput

What are the commercial end points: share, volume, and net price?

For mature ophthalmic analgesics:

• Volume is driven by cataract procedure load and perioperative prescribing patterns
• Net price declines are the dominant financial variable after generic penetration
• Brand share can stabilize only when net price gaps narrow or preferred contracting exists

What to model for financial trajectory

A business forecast for ACULAR should treat:

• Unit demand as a proxy for procedure volume trends
• Gross-to-net as a structural downward variable due to discounting and substitution
• Ongoing headwind from additional generic entries and class-level competition

Key scenarios for ACULAR’s next 3–5 years

Base case

• Continued generic share pressure
• Modest stabilization in residual brand coverage
• Revenue growth constrained to procedure growth and minor pricing offsets

Downside case

• Additional generic intensity or lower-cost supply shifts
• Faster formulary switching among surgery centers
• Further net price compression

Upside case

• Temporary supply constraints at key generic manufacturers
• Favorable contracting that locks brand shelf presence
• Targeted retention in select patient segments

Key Takeaways

• ACULAR’s market dynamics are dominated by perioperative ophthalmic procedure volumes and sustained generic substitution.
• Financial trajectory is characterized by brand premium erosion, followed by stabilization at reduced share.
• Patent and Orange Book dynamics for mature ketorolac ophthalmics typically do not support long-term premium pricing.
• Competitive outcomes depend more on net price, formulary status, and dosing convenience across ophthalmic NSAIDs than on molecule-specific differentiation.
• Forecasting should prioritize gross-to-net compression, unit demand tied to cataract throughput, and ongoing class competition intensity.

FAQs

1) Is ACULAR protected from generic competition by any recent Orange Book exclusivities?
For mature ketorolac ophthalmic products, exclusivity typically does not prevent continued generic availability.

2) How do cataract surgery trends translate into ACULAR demand?
They influence the number of perioperative NSAID prescriptions tied to post-operative pain and inflammation protocols.

3) Which ophthalmic NSAID usually substitutes for ACULAR on formularies?
Substitution often shifts within the class toward the lowest net price and preferred dosing frequency (e.g., bromfenac or nepafenac formulations), depending on contracting.

4) What drives net price erosion for mature branded ophthalmic solutions?
Wholesaler and payer discounting plus rapid pharmacy and surgery-center substitution to ketorolac generics.

5) Does patent litigation materially change ACULAR’s long-term revenue model?
For long-established ketorolac ophthalmics, litigation outcomes rarely overturn structural generic pricing pressures unless a late-cycle, specifically enforceable patent remains active.

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA labels for ACULAR (ketorolac tromethamine ophthalmic solution) and class comparator ophthalmic NSAIDs. U.S. Food and Drug Administration.

DrugChatter Q&A for ACULAR

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