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 Pharma Ltd, 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:	71
Clinical Trials:	4
Patent Applications:	230
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
Abbvie	LASTACAFT	alcaftadine	SOLUTION/DROPS;OPHTHALMIC	022134-001	Jul 28, 2010		OTC	Yes	Yes			Y
Gland Pharma Ltd	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

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
South Korea	101321731
Peru	20080053	COMPOSICIONES OFTALMICAS DE ALCAFTADINA
Poland	3150209

ALCAFTADINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Alcaftadine

Introduction to Alcaftadine

Alcaftadine is an antihistamine and mast cell stabilizer used primarily in the treatment of allergic conjunctivitis, a common condition characterized by inflammation of the conjunctiva due to allergens such as pollen, dust, and mold. This medication is part of a broader market segment that is experiencing significant growth due to several key factors.

Market Growth Drivers

Rising Prevalence of Eye Allergies

The increasing prevalence of eye allergies and associated conditions like hay fever, asthma, and eczema is a primary driver of the market growth for alcaftadine. As more people suffer from these conditions, the demand for effective treatments like alcaftadine increases, contributing to market expansion[1].

Robust Awareness and Reimbursement

Government campaigns and programs aimed at raising awareness about the treatment of allergic conjunctivitis have significantly boosted the market. Additionally, government support through reimbursement policies for new drug delivery systems reduces the economic burden on patients, further enhancing product adoption[1].

Increasing Demand for Antihistamines & Mast Cell Stabilizers

The segment of antihistamines and mast cell stabilizers, which includes alcaftadine, is projected to lead the market. This is due to the increasing demand for these medications to control allergic reactions, as they effectively mitigate the clinical signs and symptoms mediated by the release of histamine by mast cells[1].

Market Segmentation and Distribution

Drug Class Segmentation

The market for allergic conjunctivitis treatments is segmented into antihistamines & mast cell stabilizers, corticosteroids, and others. The antihistamines & mast cell stabilizers segment, which includes alcaftadine, dominates the market and is expected to grow at a significant CAGR during the forecast period[1].

Distribution Channels

The distribution of alcaftadine and other allergic conjunctivitis treatments is primarily through drug stores & retail pharmacies, which hold a substantial share of the market. Online pharmacies also play a significant role, offering convenience and ease of availability, which is further boosted by the rising use of technology and e-commerce platforms[1].

Competitive Landscape

Key Players

The market for allergic conjunctivitis treatments is fragmented, with several key players. Alcon Inc. holds a significant position due to its robust product portfolio and strong regulatory approvals. Other major players include Bausch + Lomb, AbbVie Inc., Teva Pharmaceutical Industries Ltd., and Ocular Therapeutix, Inc. These companies are focused on introducing innovative and generic products, which is expected to enhance their market presence[1].

Strategic Initiatives

Companies are engaging in various strategic initiatives such as gaining regulatory approvals, launching new products over-the-counter, and collaborating with retail channels. These initiatives are crucial for maintaining market share and driving growth. For instance, Alcon Inc.'s emphasis on obtaining regulatory approvals for its key products has helped the company maintain its position in the market[1].

Financial Trajectory

Market Size and Growth

The U.S. allergic conjunctivitis market, which includes alcaftadine, is expected to grow from $1.43 billion in 2024 to $2.32 billion by 2032, at a CAGR of 6.2% during the forecast period. This growth is driven by the increasing prevalence of eye allergies, rising awareness, and favorable reimbursement policies[1].

Revenue Contribution

The antihistamines & mast cell stabilizers segment, which includes alcaftadine, is anticipated to contribute significantly to the market revenue. The growing demand for these medications and the increasing availability of these drugs over-the-counter are key factors driving this segment's growth[1].

Challenges and Limitations

Adverse Events Associated with Medications

Despite the growth potential, the market faces challenges such as adverse drug reactions associated with the available medications. These side effects can reduce consumer trust and limit the adoption of products, including alcaftadine, thereby hindering market growth[1].

Innovative Trends and Developments

New Therapies and Product Launches

The development of new therapies for allergic conjunctivitis is a key trend in the market. Major players are focusing on launching innovative products and gaining regulatory approvals to stay competitive. This trend is expected to continue, driving market growth and innovation[1].

Geographical Performance

U.S. Market Dominance

The U.S. market is a significant contributor to the global allergic conjunctivitis treatment market. Companies like Alembic Pharmaceuticals Limited are expanding their presence in the U.S. market through new product launches and regulatory approvals, which is expected to drive revenue growth[2].

Key Takeaways

• The U.S. allergic conjunctivitis market, including alcaftadine, is expected to grow significantly due to rising prevalence of eye allergies and increased awareness.
• Antihistamines & mast cell stabilizers, such as alcaftadine, dominate the market and are expected to grow at a significant CAGR.
• Distribution through drug stores, retail pharmacies, and online pharmacies is crucial for market growth.
• Key players like Alcon Inc., Bausch + Lomb, and AbbVie Inc. are driving market growth through strategic initiatives.
• Adverse drug reactions remain a challenge that could impact market growth.

FAQs

1. What is the expected growth rate of the U.S. allergic conjunctivitis market?

The U.S. allergic conjunctivitis market is expected to grow at a CAGR of 6.2% from 2024 to 2032[1].

2. Which segment dominates the U.S. allergic conjunctivitis market?

The antihistamines & mast cell stabilizers segment, which includes alcaftadine, dominates the U.S. allergic conjunctivitis market[1].

3. What are the primary drivers of the market growth for alcaftadine?

The primary drivers include the rising prevalence of eye allergies, robust awareness campaigns, and favorable reimbursement policies[1].

4. Which companies are key players in the U.S. allergic conjunctivitis market?

Key players include Alcon Inc., Bausch + Lomb, AbbVie Inc., Teva Pharmaceutical Industries Ltd., and Ocular Therapeutix, Inc.[1].

5. What challenges does the market for alcaftadine face?

The market faces challenges such as adverse drug reactions associated with the available medications, which can reduce consumer trust and limit product adoption[1].

Sources

1. Fortune Business Insights: U.S. Allergic Conjunctivitis Market Size, Share | Report [2032]
2. Alembic Pharmaceuticals Limited: Vantage Plus Report
3. Allergan: 2011 Annual Report
4. Mordor Intelligence: Allergy Relieving Eye Drops Market - Trends, Growth, Forecast & Size