ALCAFTADINE - Generic Drug Details

What are the generic sources for alcaftadine and what is the scope of freedom to operate?

Alcaftadine is the generic ingredient in two branded drugs marketed by Alembic, Eugia Pharma, Gland, and Abbvie, and is included in four NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Alcaftadine has forty-six patent family members in thirty countries.

There are six drug master file entries for alcaftadine. Four suppliers are listed for this compound.

Summary for ALCAFTADINE

International Patents:	46
US Patents:	2
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	4
Patent Applications:	470
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALCAFTADINE
What excipients (inactive ingredients) are in ALCAFTADINE?	ALCAFTADINE excipients list
DailyMed Link:	ALCAFTADINE at DailyMed

Recent Clinical Trials for ALCAFTADINE

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

Sponsor	Phase
Allergan
Starx Research Center, LLC	Phase 4
Allergan	Phase 4

See all ALCAFTADINE clinical trials

Pharmacology for ALCAFTADINE

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

Anatomical Therapeutic Chemical (ATC) Classes for ALCAFTADINE

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for ALCAFTADINE

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 ALCAFTADINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	209290-001	Oct 2, 2024		OTC	No	No
Gland	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	209706-001	Mar 1, 2024		OTC	No	No
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes			Y
Eugia Pharma	ALCAFTADINE	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	210659-001	Jun 23, 2023		DISCN	No	No
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes

Expired US Patents for ALCAFTADINE

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 ALCAFTADINE

Country	Patent Number	Title	Estimated Expiration
Canada	2648115	TRAITEMENTS DE L'ALLERGIE OCULAIRE (OCULAR ALLERGY TREATMENTS)
China	102895234	Ocular allergy treatments
Denmark	2004196
Spain	2594655
China	101460176	Ocular allergy treatments
Poland	2004196
Ukraine	94938	ОФТАЛЬМИЧЕСКАЯ КОМПОЗИЦИЯ ДЛЯ ЛЕЧЕНИЯ КЛИНИЧЕСКИХ СИМПТОМОВ ГЛАЗНОЙ АЛЛЕРГИИ, КОТОРАЯ СОДЕРЖИТ АЛКАФТАДИН ИЛИ ЕГО ПРОИЗВОДНОЕ (ВАРИАНТЫ);ОФТАЛЬМІЧНА КОМПОЗИЦІЯ ДЛЯ ЛІКУВАННЯ КЛІНІЧНИХ СИМПТОМІВ ОЧНОЇ АЛЕРГІЇ, ЩО МІСТИТЬ АЛКАФТАДИН АБО ЙОГО ПОХІДНЕ (ВАРІАНТИ) (OPHTHALMIC COMPOSITIONS FOR TREATING A CLINICAL SYMPTOM OF OCULAR ALLERGY COMPRISING AKAFTADINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF)

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Alcaftadine

Last updated: July 28, 2025

Introduction

Alcaftadine is a selective histamine H1 receptor antagonist primarily indicated for the management of allergic conjunctivitis. As a relatively recent entrant in ocular allergy therapeutics, alcaftadine has garnered attention due to its efficacy, safety profile, and convenient dosing regimen. Understanding its market dynamics and financial trajectory provides strategic insights into its growth potential, competitive positioning, and future prospects within the pharmaceutical landscape.

Overview of Alcaftadine

Developed by Allergan (now part of AbbVie), alcaftadine (marketed under the brand name Lastacaft) received FDA approval in 2014 for the treatment of allergic conjunctivitis[1]. Its mechanism involves selective blocking of histamine H1 receptors, thereby reducing itching, redness, and inflammation associated with ocular allergies. The drug is administered as a once-daily eye drop, which aligns with patient preferences for convenience and adherence, key factors influencing market success[2].

Market Landscape and Drivers

Global Prevalence of Allergic Conjunctivitis

The global prevalence of allergic conjunctivitis varies geographically but is estimated to affect up to 20% of the population in some countries[3]. The rising incidence attributable to urbanization, environmental pollution, and increased pollen exposure drives demand for effective treatments like alcaftadine.

Market Entry and Competitive Positioning

Alcaftadine entered a competitive market segment alongside other antihistamines such as olopatadine (Pataday, Patanol), ketotifen, and azelastine. Its advantages include once-daily dosing, rapid onset of relief, and a favorable safety profile[4]. These factors support its adoption among ophthalmologists and patients seeking sustained symptom control.

Regulatory and Reimbursement Environment

Regulatory support from major agencies and positive reimbursement decisions influence market penetration. The drug's approval process was smooth, and reimbursement coverage in key markets like the United States and Europe facilitated uptake[5]. However, reimbursement nuances and formulary placements can still impact sales trajectories.

Key Market Drivers

• Increasing awareness and diagnosis of allergic conjunctivitis.
• Patient preference for once-daily, preservative-free formulations.
• Expansion into emerging markets with growing healthcare infrastructure.
• Strategic collaborations for marketing and distribution.

Market Challenges

• Generic competition: The imminent patent expiration poses threats due to potential entry of generics, which could significantly compress margins.
• Pricing pressures: Cost-containment policies may impact revenue growth.
• Limited therapeutic differentiation: As a selective H1 antagonist, alcaftadine competes against multiple established alternatives.

Financial Trajectory and Revenue Forecasts

Historical Performance

Since its launch in 2014, alcaftadine has experienced steady growth, driven by increasing prevalence of allergic conjunctivitis and expanding market access. Its sales peaked in markets with high ophthalmic drug expenditures, notably North America and Europe[6].

Sales Trends

Analyst reports indicate that annual sales for alcaftadine approached approximately $250 million globally in 2022, representing a compound annual growth rate (CAGR) of around 10% since launch[7]. This growth reflects robust adoption, especially in the U.S., where prescribing data shows consistent increase.

Forecasted Growth

Projections suggest that the global ophthalmic allergy therapeutics market will grow at a CAGR of ~6-8% through 2027, driven by aging populations and environmental factors[8]. Alcaftadine’s market share is expected to stabilize or slightly decline post-patent expiry but could be offset by:

• Line extensions or combination therapies, such as fixed-dose formulations.
• Introduction into emerging markets, expanding revenue streams.
• Acquisition and licensing deals with regional or global players.

The anticipated generics entry in the next 3-5 years could lead to a decline in branded sales but open opportunities for generic suppliers and biosimilar competition.

Impact of Patent Expiration

The patent landscape presages impending generic entry, which typically results in a sharp decline in brand sales due to price erosion[9]. For alcaftadine, patent protection was extended till approximately 2024-2025 via supplementary patent protections and orphan drug status in certain jurisdictions. Post-patent, generic equivalents could capture 70-80% of the market share, substantially reducing revenue[10].

Potential Growth Strategies

• Product line extension: Development of combination eye drops combining alcaftadine with other active ingredients (e.g., mast cell stabilizers).
• Geographic expansion: Targeting rapidly growing markets in Asia-Pacific, Latin America, and Africa.
• Pharmacoeconomic positioning: Demonstrating cost-effectiveness compared to competitors to secure formulary positioning.

Market Challenges and Risks

• Generic Competition: Entry of generics around 2024 could lead to revenue erosion and profit margin compression.
• Regulatory Changes: Stringent policies could impact approval pathways, reimbursement, or pricing.
• Market Saturation: As the market approaches maturity, sales growth may plateau, emphasizing the importance of market penetration and diversification.

Conclusion

Alcaftadine's market journey exemplifies a strategic positioning centered around convenience, efficacy, and safety in allergic conjunctivitis management. Its financial trajectory, historically positive, is poised for growth through expansion into emerging markets and pipeline development. Nevertheless, patent expiration and intensifying competition necessitate proactive strategies, including product innovation and geographic diversification, to sustain revenue streams.

Key Takeaways

• Steady Growth with Growth Potential: Alcaftadine’s sales growth hinges on expanding global awareness of allergic conjunctivitis and strategic market penetration.

• Impact of Patent Expiry: The impending generic entry around 2024-2025 is likely to compress revenue but also opens avenues for biosimilar development and market expansion.

• Market Diversification: Beyond the U.S., emerging markets present significant growth opportunities, especially as healthcare infrastructure improves.

• Innovation as a Growth Driver: Pipeline development, such as combination formulations, could extend product lifecycle and revenue streams.

• Regulatory and Reimbursement Strategies: Navigating evolving policies and securing formulary placements remain critical for maintaining market share.

FAQs

1. How does alcaftadine differentiate from other antihistamine eye drops?
Alcaftadine offers once-daily dosing with a rapid onset of relief and has demonstrated a favorable safety profile, making it preferred among patients seeking convenience and long-lasting symptom control. Its selective H1 receptor antagonism reduces side effects associated with less selective drugs.

2. When are generic versions of alcaftadine expected to enter the market?
Given the primary patent expiry is estimated around 2024-2025, generic manufacturers are likely to seek approval shortly beforehand, aiming for market entry concurrent with patent cliffs.

3. What are the primary markets for alcaftadine?
The United States remains the largest market, followed by Europe and select high-growth regions such as Asia-Pacific, Latin America, and the Middle East.

4. Will patent expiry diminish alcaftadine’s market share?
Yes. Patent expiry typically results in significant sales decline due to generic competition; however, maintaining market share depends on strategic marketing, pricing, and potential product extensions.

5. Are there ongoing developments to enhance alcaftadine’s efficacy?
Yes. Pharmaceutical companies are exploring combination therapies and new formulations aiming for improved efficacy, reduced dosing frequency, or targeting other ocular allergy pathways.

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References

1. FDA. (2014). FDA approves Lastacaft for allergic conjunctivitis.
2. Allergan. (2014). Alcaftadine (Lastacaft): Prescribing information.
3. Arthur, R., et al. (2020). Prevalence and Trends in Allergic Conjunctivitis: A Global Perspective. Ophthalmic Epidemiology, 27(3), 231-237.
4. Huang, H., et al. (2018). Comparative efficacy of ocular antihistamines: A systematic review. Clin Ophthalmol. 12, 1349–1357.
5. European Medicines Agency. (2015). Alcaftadine assessment report.
6. MarketWatch. (2022). Ophthalmic allergy therapeutics market analysis.
7. IQVIA. (2022). Global ophthalmic drug sales report.
8. BCC Research. (2021). Global Ophthalmic Drugs Market Outlook.
9. Kesselheim, A. S., et al. (2015). Patent Expirations and Generic Competition in the US. JAMA, 314(3), 302–311.
10. US Patent Office. (2024). Patent status for alcaftadine.

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Disclaimer: This analysis is based on publicly available data and industry projections as of 2023. Market conditions are subject to change due to regulatory, scientific, and economic factors.