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:	248
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
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes			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

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

Australia

Brazil

Canada

Chile

China

Costa Rica

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

New Zealand

Nicaragua

Norway

Peru

Poland

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

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
Uruguay	30254	TRATAMIENTOS PARA LA ALERGIA OCULAR
Austria	250061
Norway	300636
Taiwan	201446249	Ocular allergy treatments

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: LASTACAFT

Last updated: July 28, 2025

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Introduction

LASTACAFT (alcaftadine ophthalmic solution 0.25%) is an antihistamine medication primarily indicated for the treatment of allergic conjunctivitis. Approved by the U.S. Food and Drug Administration (FDA) in 2015, LASTACAFT has established itself within the ophthalmic antihistamine market. As a late-entry product in this space, understanding its market dynamics and financial prospects involves analyzing competitive positioning, evolving allergenic conjunctivitis prevalence, regulatory pathways, and potential growth drivers.

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Market Landscape

Global Ophthalmic Antihistamine Market Overview

The global ophthalmic antihistamine market was valued at approximately USD 400 million in 2022 and is projected to reach around USD 560 million by 2030, reflecting a compound annual growth rate (CAGR) of about 4.0% (source: Future Market Insights). The increasing prevalence of allergic conjunctivitis, driven by environmental factors, urbanization, and heightened awareness, fuels product demand. Additionally, advancements in targeted ophthalmic treatments and improved drug delivery mechanisms further shape market prospects.

Key Competitors and Market Share

LASTACAFT operates in a competitive landscape with key players including:

• Olopatadine-based products: Pataday (0.2%) and Patanol (0.1%) by Alcon, which dominate over 70% of the market share due to their established presence and broad clinician familiarity.
• Azelastine: Available in some markets as an antihistamine eye drop.
• Antazoline-based medications: Limited but emerging rivals in specific regional markets.

LASTACAFT’s positioning hinges on its unique formulation, dosing schedule (once daily), and FDA approval for both prevention and relief of ocular allergy symptoms.

Regulatory and Reimbursement Environment

In the U.S., ophthalmic antihistamines benefit from a favorable regulatory landscape, with multiple drugs already approved and reimbursed through Medicare and private insurers. However, the market’s profitability hinges on formulary inclusion and physician prescribing behaviors. Continued efforts in market access can influence revenue streams, especially as new entrants seek to differentiate their products.

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Market Drivers and Constraints

Drivers

• Rising prevalence of allergic conjunctivitis: Studies indicate up to 40% of the population experiences ocular allergy symptoms, creating persistent demand (source: AAAAI).
• Shift toward patient convenience: The once-daily dosing of LASTACAFT enhances adherence and positions it favorably against more frequent dosing competitors.
• Innovative drug development: The ophthalmic market favors drugs with rapid onset, durable effect, and minimal side effects—areas where LASTACAFT performs competitively.
• Expanding indications: Potential off-label uses or broader allergic conjunctivitis applications can unlock additional revenue.

Constraints

• Market saturation: Dominance by established products limits growth potential unless LASTACAFT exploits unmet needs.
• Pricing pressures: Competitive pricing and formulary negotiations constrain profit margins.
• Slow adoption curve: Prescriber familiarity with competitors and conservative shifts in treatment practices may delay uptake.
• Regional regulatory hurdles: Variants in approvals and reimbursement policies across countries influence international growth trajectory.

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Financial Trajectory Analysis

Sales Revenue Potential

Initial sales post-launch in 2015 were modest, as expected for a specialty ophthalmic drug, with estimates of USD 10–15 million in the first year within the U.S. [1]. As awareness increased and physician prescriptiveness elevated, revenue growth trended upward, reaching approximately USD 60 million globally by 2022.

Given the growth trajectory, projections indicate:

• Short-term (2023–2025): Moderate growth, 5–7% CAGR, driven by increased market penetration and geographic expansion.
• Medium-term (2026–2030): Accelerated growth potential of approximately 8–10% CAGR if LASTACAFT gains formulary listing advantages and expands into emerging markets such as Europe and Asia.

Profitability Outlook

Gross margins for ophthalmic solutions typically hover around 80–85%, driven by low manufacturing costs. However, marketing expenses and physician education campaigns influence net margins. Considering conservative investments and market competition, profit margins may stabilize around 25–30%.

Pharmaceutical Investment and Development Outlook

Pharmaceutical companies may explore pipeline enhancements, such as combining LASTACAFT with other antihistamines or anti-inflammatory agents, to extend patent life and create next-generation formulations. Additionally, pursuing novel delivery systems like sustained-release implants could revolutionize treatment adherence and market share.

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Emerging Trends and Future Outlook

• Digital health integration: Telemedicine and digital monitoring can facilitate patient engagement and prescription adherence.
• Personalized medicine: Biomarkers identifying patients most responsive to antihistamines could refine prescribing, improving outcomes and market efficiency.
• Pricing strategies: Value-based pricing models, emphasizing improved quality of life and reduced healthcare utilization, could enhance profitability.

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Conclusion: Outlook for LASTACAFT

The financial trajectory of LASTACAFT is promising, with sustained growth driven by the increasing prevalence of allergic conjunctivitis and market preferences for convenience and efficacy. However, competitive pressures necessitate strategic differentiation and expansion into new markets. The drug's long-term financial success will depend on regulatory agility, formulary positioning, and ongoing innovation efforts.

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Key Takeaways

• LASTACAFT’s market remains competitive predominantly occupied by olopatadine formulations; differentiation via dosing convenience and formulary positioning is critical.
• The global ophthalmic antihistamine market is expected to grow steadily, offering revenue opportunities through geographical expansion.
• Financial forecasts project a moderate growth rate (5–10% CAGR), with increased uptake expected from new geographic and indication expansions.
• Cost management, strategic partnerships, and pipeline development will influence long-term profitability.
• Adoption barriers include entrenched competitors and pricing pressures, necessitating targeted marketing and healthcare provider engagement.

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FAQs

1. What distinguishes LASTACAFT from other antihistamine eye drops?
   LASTACAFT offers a once-daily dosing regimen, rapid symptom relief, and FDA approval for both prevention and treatment of allergic conjunctivitis, providing convenience and efficacy advantages over some competitors.

2. What is the expected market growth rate for LASTACAFT over the next decade?
   The ophthalmic antihistamine market is projected to grow at approximately 4-6% CAGR globally, with LASTACAFT expected to follow this trend, possibly achieving 5–10% annually with expansion.

3. Are there any regulatory challenges facing LASTACAFT?
   While current approvals are stable in major markets like the U.S. and Europe, future challenges include gaining approvals in emerging markets and navigating differences in regulatory requirements.

4. How does the competitive landscape impact LASTACAFT's revenue prospects?
   Dominance by well-established products like Pataday and Patanol constrains growth; regulatory and formulary challenges require strategic marketing and clinical differentiation for LASTACAFT.

5. What future innovations could enhance LASTACAFT’s market share?
   Developing sustained-release formulations, combination therapies, and leveraging digital health solutions can improve adherence, efficacy, and patient satisfaction, expanding market share.

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References

[1] MarketWatch. "Ophthalmic Anti-Allergy Market Report," 2022.
[2] Future Market Insights. "Global Ophthalmic Drugs Market Outlook," 2022.
[3] American Academy of Allergy, Asthma & Immunology (AAAAI). "Prevalence of Allergic Conjunctivitis," 2021.