LASTACAFT Drug Patent Profile

Which patents cover Lastacaft, and when can generic versions of Lastacaft launch?

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

This drug has forty-six patent family members in thirty countries.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the alcaftadine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lastacaft

A generic version of LASTACAFT was approved as alcaftadine by GLAND on March 1^st, 2024.

Summary for LASTACAFT

International Patents:	46
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	5
Patent Applications:	260
Drug Prices:	Drug price information for LASTACAFT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LASTACAFT
What excipients (inactive ingredients) are in LASTACAFT?	LASTACAFT excipients list
DailyMed Link:	LASTACAFT at DailyMed

See drug prices for LASTACAFT

Recent Clinical Trials for LASTACAFT

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

Sponsor	Phase
Allergan
ORA, Inc.	Phase 4
Starx Research Center, LLC	Phase 4

See all LASTACAFT clinical trials

Pharmacology for LASTACAFT

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Paragraph IV (Patent) Challenges for LASTACAFT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LASTACAFT	Ophthalmic Solution	alcaftadine	0.25%	022134	1	2014-07-30

US Patents and Regulatory Information for LASTACAFT

LASTACAFT is protected by two 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	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes	8,664,215
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes	10,617,695		Y

Expired US Patents for LASTACAFT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010	5,468,743

International Patents for LASTACAFT

When does loss-of-exclusivity occur for LASTACAFT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Costa Rica

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LASTACAFT around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	060278	TRATAMIENTOS DE LAS ALERGIAS OCULARES
Argentina	111697	COMPOSICIÓN OFTÁLMICA PARA EL TRATAMIENTO DE LAS ALERGIAS OCULARES
Australia	2007234957	Ocular allergy treatments
Brazil	PI0710085	tratamentos de alergia ocular
Canada	2648115	TRAITEMENTS DE L'ALLERGIE OCULAIRE (OCULAR ALLERGY TREATMENTS)
Chile	2007000916	Uso de alcaftadina y de acido 6,11-dihidro-11-(1-metil-4-piperidiniliden)-5h-imidazo[2,1-b][3]benzazepin-3-carboxilico, sales, n-oxidos, solvatos e hidratos para tratar sintomas de alergia ocular, inflamacion ocular y sintomas nasales de alergia ocular; composiciones oftalmicas que los comprenden; su uso y kit farmaceutico.
China	101460176	Ocular allergy treatments

Last updated: July 29, 2026

LASTACAFT (alcaftadine) market dynamics and financial trajectory: pricing, growth drivers, payer access, and exclusivity impact

LASTACAFT (alcaftadine) eye drops generated meaningful but bounded U.S. revenue since launch, with a trajectory shaped by (1) competitive pressure in allergic conjunctivitis, (2) payer restrictions and contracting dynamics for branded ophthalmology products, and (3) exclusivity and generic entry risk as Orange Book protection expires. Market dynamics in the category are dominated by substitution among OTC and branded prescription antihistamine/mast-cell stabilizer drops, rapid payer cycling, and formulary placement driven by dosing convenience and documented comparative effectiveness.

Because “LASTACAFT” is the brand name and the request does not specify jurisdiction or time window, the only accurate analysis is a structured competitive-and-exclusivity framework that connects known launch/exclusivity mechanics to how revenue typically evolves in U.S. ophthalmology. No verified financial dataset (company revenue by product, publicly reported net sales, or payer/contract metrics) is provided here, so a complete financial trajectory with quantified sales cannot be produced.

What is Lastacaft’s market position in allergic conjunctivitis?

LASTACAFT (alcaftadine 0.25%) is positioned for allergic conjunctivitis with once-daily dosing. Its core market dynamic is the trade-off between branded prescription access and lower-cost substitution into competing antihistamine/mast-cell stabilizer ophthalmics, including both branded and generic options.

Category demand drivers

• Seasonal allergy incidence drives usage seasonality (second and third quarters typically represent the highest demand in many U.S. markets).
• Prescribing is influenced by perceived onset and symptom control, which affects formulary value dossiers and prior authorization thresholds.
• Ocular tolerability and dosing adherence affect therapeutic switching between agents.

Competitive pressure mechanisms

• Multiple molecules compete in the same therapeutic niche: antihistamines, mast-cell stabilizers, and combination products.
• Payers manage costs via step therapy, coverage tiers, and contracting that favors agents with strong net pricing and demonstrable formulary fit.
• Brand-to-brand switching can occur within the same class when payers revise preferred lists.

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How do exclusivity and patent timelines affect LASTACAFT revenue?

Revenue durability for LASTACAFT depends on U.S. regulatory exclusivity and the Orange Book patent estate tied to the approved formulation (alcaftadine ophthalmic solution) and any coverable changes (method-of-use, formulation, stability, or manufacturing).

Which exclusivity windows matter for LASTACAFT?

Key levers that determine how long generic or labeled competitors can take share without immediate substitution are:

• Orange Book-listed patents expiring by claims coverage.
• Regulatory exclusivity (as applicable) that can block ANDA or limit launch timing even after patent expiry.
• Practical enforcement posture: whether challengers file Paragraph IV certifications and whether settlements delay entry.

When does LASTACAFT face generic entry risk?

Generic entry risk occurs in phases:

1. Pre-expiry: formulary contracting tightens, insurers increase preferred alternatives, and net prices often decline through rebate pressure.
2. Patent expiry: if no blocking patents remain, generic approval timing accelerates.
3. Launch and settlement effects: first generic entry typically resets pricing, and branded sales decline rapidly unless the brand maintains strong formulary placement through aggressive discounts.

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What patents protect LASTACAFT in the U.S., and how do they shape generic competition?

LASTACAFT’s ability to sustain branded revenue depends on the breadth of its Orange Book patent set: composition/formulation, method-of-use, and related manufacturing or stability claims.

What to check in the Orange Book for LASTACAFT

For a complete patent landscape, the Orange Book record for the active ingredient and dosage form should be reviewed for:

• Patent number(s)
• Patent expiration dates
• Patent type codes
• Claim scope (how broadly each patent covers therapeutic use, formulation, concentration, or method)

How patent strength translates to revenue

• Strong composition/formulation coverage typically prolongs brand pricing power and delays generic substitution.
• Narrow method-of-use coverage can still delay generic entry for specific labeling but may allow “off-label” substitution behavior that reduces branded demand.
• Multiple blocking patents can extend the timeline even if the earliest expiring patent passes.

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What market dynamics determine LASTACAFT’s pricing and net revenue per prescription?

Branded ophthalmic products typically experience a predictable pricing arc:

• Launch: higher list price and higher net price after initial contracting.
• Mid-cycle: payer rebates and coverage decisions adjust net price downward if formulary preferences shift.
• Pre-generic: net price often declines faster due to competitive anticipation.
• Post-generic: branded net revenue per script can drop sharply, especially when generics become first-line preferred.

Payer and contracting dynamics

• Preferred formulary status drives volume and reduces switching to competing drops.
• Coverage restrictions (step therapy, prior authorization) reduce volume but can protect net price if the brand remains the lowest-cost preferred.
• Contracting with PBMs can shift demand between similar agents based on estimated class economics.

Wholesale acquisition cost pressure

In ophthalmology, net price behavior usually follows:

• rebate increases or maintenance of rebates when brand remains preferred
• rebate compression as generics or competing brands gain preferred status

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How does LASTACAFT compare with competing ophthalmic antihistamines on market access?

Competitive comparison is central in allergic conjunctivitis because payer committees choose “preferred” agents by:

• dosing schedule (once daily often supports adherence and formularies)
• formulary value (clinical endpoints and value dossiers)
• net cost after rebates and performance tiers

Competitor set relevant to formulary decisions (conceptual)

• Other branded once-daily antihistamine/mast-cell stabilizers
• Generic antihistamine drops that compete on price
• Combination agents that sometimes win formulary when they show superior symptom relief profiles

What usually happens when competing agents become preferred?

• Net price for the brand typically falls to defend shelf position.
• Prescriptions shift to preferred alternatives quickly if step therapy or restrictive coverage is used.
• Marketing spend reallocates toward remaining accounts, accelerating share erosion.

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How does FDA regulatory status influence LASTACAFT’s competitive risk?

FDA status drives the pipeline timing for generics and labeled competitors through:

• ANDA submissions and approval timing
• labeling changes that can alter switching patterns
• post-approval supplement cadence that may shift patent coverage arguments

Regulatory pathway signals to monitor

• ANDA filings referencing the approved drug
• amendments or supplements that can create additional patents through coverable changes
• labeling updates affecting method-of-use protection

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What generic entry risks exist for LASTACAFT, including Paragraph IV challenges and settlements?

Generic entry risk is managed through:

• Paragraph IV filings that can trigger 180-day exclusivity for the first ANDA filer (if eligible)
• patent litigation that can lead to automatic stays or settlement-triggered “launch delay” windows
• “design-around” strategies if alternative formulations or bottle volumes change claim coverage

What settlement effects typically do to the branded financial trajectory

Settlements often produce:

• delayed generic launch
• brand share retention during the delay period
• step-down volume trajectory once generic entry finally occurs
• post-launch pricing pressure that continues through subsequent entrants

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What formulation, dosing, or method-of-use patents could affect LASTACAFT switching?

For ophthalmic products, patent estates can include:

• concentration-specific formulation protection
• viscosity or excipient-related stability claims
• method-of-use claims tied to dosing regimens or patient groups (where available)

What this means for generic substitutes

If generics can remain outside key method-of-use claims, they may still enter at label boundaries but achieve less substitution if prescriber behavior follows protected labeled use.

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How does the LASTACAFT financial trajectory typically evolve through the exclusivity lifecycle?

Without quantified net sales data, the correct business model is the standard branded ophthalmic lifecycle pattern:

1. Early growth phase post-launch
   • establishes prescriber habits
   • forms payer preference through early contracting
2. Mid-cycle consolidation
   • share stabilizes if the brand remains preferred and pricing is defensible
   • rebate and contracting become more aggressive
3. Pre-expiry de-risking
   • payer prepares for generic substitution; preferred alternatives shift
   • brand net pricing declines as insurers push for lower-cost options
4. Entry and share reset
   • first generic entry triggers sharp volume and price decline
   • subsequent entrants accelerate margin compression
5. Long-tail stabilization
   • residual branded demand remains where coverage stays open or where prescribers avoid substitution due to tolerability or perceived efficacy

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Key takeaways

• LASTACAFT’s revenue trajectory is primarily determined by U.S. patent coverage breadth and Orange Book timing, then secondarily by payer contracting and competitive substitutions in allergic conjunctivitis drops.
• Branded ophthalmology products typically experience pricing pressure in the pre-expiry period and accelerated net sales declines after first generic entry.
• A complete, quantified financial trajectory requires verified product net sales by period; the exclusivity-and-competition mechanism can be mapped, but numeric sales cannot be stated from the information provided.

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FAQs

1. What drives payer formulary coverage for alcaftadine (LASTACAFT) versus other allergic conjunctivitis eye drops?
   Preferred status typically depends on net pricing after rebates, dosing convenience, and comparative clinical value dossiers that influence step therapy and prior authorization rules.

2. How do Orange Book patents and regulatory exclusivity interact to delay generic competition for LASTACAFT?
   Orange Book patent expiry can be blocked by additional listed patents, while regulatory exclusivity (when applicable) can limit the timing of approvals and launch even after some patents expire.

3. What is the typical impact of a first ANDA Paragraph IV settlement on LASTACAFT net sales?
   Settlement delays launch, preserving branded share temporarily; when the delay ends, branded sales often step down quickly as generics become preferred.

4. How does once-daily dosing affect switching behavior from LASTACAFT to generic or competing brands?
   Once-daily regimens can reduce adherence friction and may protect share longer, but payer policies and net cost typically override dosing convenience over time.

5. What formulation changes can matter commercially if patents cover specific alcaftadine ophthalmic solution attributes?
   Changes that affect concentration, excipient systems, viscosity, stability, or container configuration can influence whether generics fall within or outside specific claim coverage, impacting entry timing and labeling substitution behavior.

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Package for LASTACAFT (alcaftadine ophthalmic solution), NDA/BLA records. U.S. Food and Drug Administration.

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