ACUVAIL Drug Patent Profile

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

Acuvail is a drug marketed by Abbvie and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in ACUVAIL 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 Acuvail

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

Summary for ACUVAIL

International Patents:	63
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	11
Patent Applications:	7,086
Drug Prices:	Drug price information for ACUVAIL
What excipients (inactive ingredients) are in ACUVAIL?	ACUVAIL excipients list
DailyMed Link:	ACUVAIL at DailyMed

See drug prices for ACUVAIL

Recent Clinical Trials for ACUVAIL

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

Sponsor	Phase
Allergan	Phase 1
Stephen J. Kim, MD	Phase 1
National Eye Institute (NEI)	Phase 1

See all ACUVAIL clinical trials

Pharmacology for ACUVAIL

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

Paragraph IV (Patent) Challenges for ACUVAIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ACUVAIL	Ophthalmic Solution	ketorolac tromethamine	0.45%	022427	1	2011-08-24

US Patents and Regulatory Information for ACUVAIL

ACUVAIL is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	8,512,717		Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	7,842,714		Y	Y
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009		RX	Yes	Yes	9,192,571		Y

Expired US Patents for ACUVAIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	ACUVAIL	ketorolac tromethamine	SOLUTION/DROPS;OPHTHALMIC	022427-001	Jul 22, 2009	8,992,952

International Patents for ACUVAIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	E538775
Australia	2009202969
Australia	2009222016

Supplementary Protection Certificates for ACUVAIL

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

Last updated: July 27, 2026

ACUVAIL (acuvail) market dynamics and financial trajectory (sales, growth, pricing, and exclusivity-driven risks)

ACUVAIL (ketorolac tromethamine ophthalmic solution; commonly referenced as Acuvail after Bayer/Alcon branding histories) is a niche ophthalmology analgesic with limited addressable market size relative to blockbuster therapeutic classes. Its financial trajectory is driven by (1) competition from other topical NSAIDs in glaucoma/cataract and post-operative pain pathways, (2) payer and channel pressure on branded pricing, (3) the shift toward generic procurement after exclusivity windows, and (4) SKU-level mix (bottle size, dosing regimens, and substitution by formulary status). Competitive dynamics are characterized by multi-source generic ketorolac ophthalmic products and class-level substitution rather than brand-level differentiation.

A complete, decision-grade financial trajectory for ACUVAIL requires a verifiable sales baseline (MAT, prescriptions, wholesaler inventory), payer channel data, and Orange Book–anchored exclusivity/patent expiration mapping. That information is not provided in the prompt.

How big is the ACUVAIL ophthalmic ketorolac market and what drives demand?

Demand drivers (featured snippet): post-cataract and other ocular procedures pain control, formulary adoption of topical NSAIDs, and substitution economics between branded and generic ketorolac products.

What clinical use cases support ACUVAIL uptake?

• Post-operative ocular pain and inflammation management where topical NSAID therapy is used.
• Short-course peri-procedural analgesia and anti-inflammatory regimens in ophthalmic surgery settings.

What is the main commercial motion: prescriptions vs procedural volume?

ACUVAIL’s revenue exposure correlates more with procedure volumes (cataract and ophthalmic surgeries) and prescribing habits than with chronic disease progression.

What payer and formulary factors decide market share?

• Preferred drug lists (PDLs) for ophthalmic anti-inflammatory analgesics.
• Generic substitution policies and contracting outcomes with major distributors.

What competitive landscape affects ACUVAIL sales and pricing?

Competition snapshot: topical NSAID ophthalmics and especially generic ketorolac ophthalmic solutions create aggressive price competition once exclusivity ends.

Which product types compete with ACUVAIL?

• Same-class topical NSAIDs for ophthalmic pain and inflammation.
• Multiple generic ketorolac ophthalmic offerings, typically driving down net prices after branded share erodes.

How does procurement pressure change ACUVAIL’s net revenue?

• Branded-to-generic switching reduces unit price and can compress volume if prescribers move to contracted generics.
• Pharmacy benefits contracting and hospital outpatient formularies can shift demand quickly.

How does channel mix influence financial trajectory?

• Retail pharmacy fills vs outpatient facility purchasing.
• Distributor buying patterns can create short-term revenue spikes and trailing inventory adjustments.

When does ACUVAIL lose exclusivity and what patent risks matter for future revenue?

Exclusivity risk (featured snippet): branded sales typically decline when patent or regulatory exclusivity barriers to generic ketorolac ophthalmic solutions clear.

What regulatory exclusivity mechanisms drive entry timing?

• Patent expiration affecting branded exclusivity.
• Potential FDA regulatory exclusivity for specific branded approvals (data protection or exclusivity terms tied to NDA/labeling events).

How do FDA ANDA approvals affect market dynamics?

• ANDA launches generally raise supply and force pricing down.
• Paragraph IV challenges can accelerate entry, shortening periods of higher net pricing.

What is the Orange Book status of ACUVAIL and how many patents cover it?

Orange Book status (featured snippet): the number, category, and expiration dates of Orange Book-listed patents determine how long branded exposure remains protected against generic substitution for specific labeled claims and formulations.

What patent categories typically matter for ophthalmic solutions?

• Composition-of-matter (active ingredient or salts).
• Formulation and concentration-specific patents.
• Method-of-use (specific dosing/indications).
• Manufacturing process patents.

Which patent types most influence generic “design-around” risk?

• Formulation and method-of-use patents can allow “same active, different formulation/label” strategies to change whether a generic can copy labeling without additional litigation.

How strong is the patent estate for ACUVAIL versus generic ketorolac ophthalmic solutions?

Patent strength (featured snippet): the effective barrier is not the number of patents, but the survivability of the most relevant claims tied to enforceable Orange Book-listed restrictions.

What litigation patterns typically occur in ophthalmic NSAID categories?

• ANDA Paragraph IV litigation is common when generic challengers attempt to enter before listed patent expirations.
• Settlements often convert to “agreed entry dates,” affecting the revenue cliff timing.

What financial trajectory should investors expect as generics erode ACUVAIL net price?

Trajectory expectation (featured snippet): net revenue usually declines after generic entry due to price compression and share loss; volume often partially offsets but typically does not restore branded net pricing power.

What do net price and unit volume typically do after generic entry?

• Net price declines first, then volume shifts toward generics.
• Branded volume can remain for prescriber inertia or formulary inertia but usually shrinks over time.

How do procurement and rebate structures amplify the decline?

• Rebates and contracting discounts on branded products can deteriorate once competitors enter.
• Formularies can switch preferred status quickly after equivalent generic availability.

What generic entry risks exist for ACUVAIL and when could revenue cliffs occur?

Entry risk (featured snippet): revenue cliffs occur at (1) patent expiration, (2) exclusivity end, or (3) settlement-to-launch dates tied to ANDA resolution.

What is the “launch calendar” concept for ophthalmic generics?

• Generic launch date drives the majority of price resets.
• Next-year underperformance often includes lag effects from inventory and contracting.

What delay mechanisms can postpone erosion?

• Exclusivity extensions via additional listed patents.
• Litigation injunctions or delayed settlement effective dates.

How does ACUVAIL compare with other topical NSAIDs for ophthalmic post-surgery pain?

Competitive comparison (featured snippet): class-level efficacy is comparable across topical NSAIDs; commercial outcomes hinge on net pricing, formulary positioning, and brand recognition in procedure settings.

Which differentiators usually move share?

• Bottle size, dosing schedule adherence, and patient/pharmacy handling.
• Contracting terms with distributors and formularies.

Why brand differentiation is often limited

• When active ingredient equivalence is accepted, prescribing decisions shift to cost and availability.

What formulations and dosing SKUs are most exposed to substitution?

SKU exposure (featured snippet): the more a branded SKU matches the contracted generic pack size, strength, and dosing, the faster substitution can occur.

What to track in quarterly reporting

• Pack-size mix and channel-level volume.
• Wholesale inventory trends that indicate timing of substitution and restocking.

What manufacturing and supply dynamics affect ACUVAIL revenue stability?

Supply risk (featured snippet): shortages or constrained manufacturing can temporarily protect price; normal supply increases substitution benefits for generics and reduces branded premiums.

What supply events typically do to the P&L

• Shortage periods can lift realized prices but often do not preserve long-term share after competition returns.
• Over-supply can accelerate discounting and rebate escalation.

What FDA pathway history and labeling scope impact market uptake?

Labeling scope (featured snippet): broad, procedure-relevant labeling supports prescriptions; any constrained label reduces addressable use and intensifies competition from broader-labeled NSAIDs.

How labeling affects switching

• If competing generics cover the same labeled use, substitution is easier.
• If label restrictions exist, litigation and design-around behavior can delay generic adoption.

Key Takeaways

• ACUVAIL’s commercial performance is primarily governed by topical NSAID substitution economics and generic ketorolac ophthalmic competition rather than by sustained brand differentiation.
• Financial trajectory is expected to move with generic entry timing, net pricing deterioration, and formulary contracting outcomes.
• Revenue risk concentrates around patent/exclusivity expiration dates and settlement-to-launch calendars tied to ANDA litigation.
• For decision-making, the critical path is Orange Book mapping to identify the exact listed patents tied to enforceable restrictions on the labeled claims most relevant to substitution, then mapping those dates to the generic launch timeline.

FAQs

1. What usually happens to ACUVAIL net pricing after ketorolac ophthalmic generics launch?
2. How do ANDA Paragraph IV challenges change the expected timing of generic entry for topical ophthalmic NSAIDs?
3. Which Orange Book patent categories most directly block generic substitution for ophthalmic solution products?
4. What formulary mechanisms drive faster switching from branded ophthalmic NSAIDs to generics?
5. How should revenue teams model volume substitution versus price erosion for niche ophthalmology brands like ACUVAIL?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. (Accessed via FDA Orange Book database).