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 PHARMA LTD 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:	70
Clinical Trials:	5
Patent Applications:	127
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
South Korea	101321731
Poland	173351
Peru	20080053	COMPOSICIONES OFTALMICAS DE ALCAFTADINA
Poland	3150209
Japan	2015131820
Japan	2009533333
Poland	170776

LASTACAFT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LASTACAFT

Introduction to LASTACAFT

LASTACAFT, also known as alcaftadine ophthalmic solution, is a prescription medication used to treat allergic conjunctivitis. It is manufactured by Allergan, now a part of AbbVie Inc., and has been a significant player in the ophthalmic market.

Market Size and Growth

The global allergic conjunctivitis market, within which LASTACAFT operates, is projected to experience substantial growth. As of 2023, the global market size was USD 3.04 billion and is expected to grow to USD 4.96 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 5.6% during the forecast period of 2024-2032[1].

Regional Market Performance

North America

North America dominates the allergic conjunctivitis market, with a significant market share of 48.68% in 2023. This region is crucial for LASTACAFT, given the high prevalence of eye allergies and the strong presence of Allergan (AbbVie Inc.) in the U.S. market. The U.S. allergic conjunctivitis market alone is expected to grow from USD 1.43 billion in 2024 to USD 2.32 billion by 2032, at a CAGR of 6.2% during the forecast period[4].

Other Regions

While North America is the leading market, other regions such as the Asia Pacific, Latin America, and the Middle East & Africa are also expected to contribute to the growth of the allergic conjunctivitis market. The Asia Pacific region, in particular, is anticipated to register the highest CAGR due to rising awareness and substantial improvements in healthcare expenditure[1].

Competitive Landscape

The allergic conjunctivitis market is characterized by a strong presence of key players, with Allergan (AbbVie Inc.), Bausch & Lomb, and Alcon being the dominant forces. LASTACAFT, as part of Allergan’s portfolio, benefits from the company’s robust product portfolio and strong market presence. Allergan’s focus on research and development, as well as its ability to secure regulatory approvals, has been instrumental in maintaining its market position[1][4].

Product Performance and Sales

LASTACAFT has been one of the fastest-growing products in Allergan’s ophthalmology segment. In the 2011 annual report, Allergan highlighted its success in the ophthalmology business, with RESTASIS being the largest single prescription ophthalmic product in the U.S. by value, and LASTACAFT contributing significantly to the company’s growth in emerging markets such as Asia, Latin America, and Eastern Europe[2].

Switch to Over-the-Counter (OTC) Medications

A significant trend in the allergic conjunctivitis market is the switch from prescription-only to OTC medications. This trend is expected to boost the adoption of therapeutics like LASTACAFT, as it increases availability and affordability. For instance, the FDA approval for Alcon’s Pataday Once Daily Relief to switch from prescription-only to OTC has set a precedent, and similar moves could enhance the market reach of LASTACAFT[1].

Regulatory Approvals and Innovations

Regulatory approvals play a crucial role in the market trajectory of LASTACAFT. Allergan has a history of securing multiple product approvals, which has contributed to its market dominance. The company’s focus on innovation and gaining approvals for new indications and formulations is expected to continue driving the growth of LASTACAFT and other products in its portfolio[2][4].

Challenges and Opportunities

Increasing Prevalence of Ocular Allergies

The rising prevalence of ocular allergies, particularly in regions like India where the prevalence was estimated to be 12.22% in 2019, presents a significant opportunity for LASTACAFT. This increase in patient population is expected to drive the demand for effective treatments like LASTACAFT[1].

Adverse Events and Competition

However, the market also faces challenges such as adverse events associated with medications, which could hinder growth. Additionally, the competitive landscape, with other major players like Bausch & Lomb and Alcon, requires continuous innovation and strategic initiatives to maintain market share[4].

Financial Performance

Allergan’s financial performance, now integrated into AbbVie Inc., reflects the strong contribution of its ophthalmic products, including LASTACAFT. In 2011, Allergan reported significant sales growth, with ophthalmology products being a key driver. The company’s investment in research and development, which increased by 12.6% to $858 million in 2011, has been crucial in maintaining its competitive edge[2].

Key Takeaways

• Market Growth: The global allergic conjunctivitis market is projected to grow significantly, driven by increasing prevalence and awareness.
• Regional Dominance: North America, particularly the U.S., is a key market for LASTACAFT, with a high CAGR expected.
• Competitive Landscape: Allergan (AbbVie Inc.) maintains a strong market position through its robust product portfolio and regulatory approvals.
• OTC Switch: The trend towards OTC medications is expected to enhance the availability and adoption of LASTACAFT.
• Regulatory Approvals: Continuous innovation and regulatory approvals are critical for the growth of LASTACAFT.

FAQs

Q: What is the projected market size for the global allergic conjunctivitis market by 2032? A: The global allergic conjunctivitis market is projected to reach USD 4.96 billion by 2032[1].

Q: Which region dominates the allergic conjunctivitis market? A: North America dominates the allergic conjunctivitis market, with a significant market share of 48.68% in 2023[1].

Q: What is the expected CAGR for the U.S. allergic conjunctivitis market from 2024 to 2032? A: The U.S. allergic conjunctivitis market is expected to exhibit a CAGR of 6.2% during the forecast period of 2024-2032[4].

Q: How does the switch to OTC medications impact the market for LASTACAFT? A: The switch to OTC medications increases the availability and affordability of LASTACAFT, leading to greater adoption and market growth[1].

Q: Which companies are the major players in the allergic conjunctivitis market? A: The major players include Allergan (AbbVie Inc.), Bausch & Lomb, and Alcon[1][4].

Sources

1. Fortune Business Insights: Allergic Conjunctivitis Market Size, Share & Growth [2032][1]
2. Allergan 2011 Annual Report: Financial Summary and Market Performance[2]
3. Pharmaceuticals.gov.in: An Analysis on leveraging the patent cliff with drug sales worth USD[3]
4. Fortune Business Insights: U.S. Allergic Conjunctivitis Market Size, Share | Report [2032][4]