XIIDRA Drug Patent Profile

When do Xiidra patents expire, and when can generic versions of Xiidra launch?

Xiidra is a drug marketed by Bausch And Lomb Inc and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and fifty-seven patent family members in twenty-five countries.

The generic ingredient in XIIDRA is lifitegrast. Three suppliers are listed for this compound. Additional details are available on the lifitegrast profile page.

DrugPatentWatch^® Generic Entry Outlook for Xiidra

Xiidra was eligible for patent challenges on July 11, 2020.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (lifitegrast), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XIIDRA

International Patents:	157
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	16
Patent Applications:	1,126
Drug Prices:	Drug price information for XIIDRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XIIDRA
What excipients (inactive ingredients) are in XIIDRA?	XIIDRA excipients list
DailyMed Link:	XIIDRA at DailyMed

See drug prices for XIIDRA

Recent Clinical Trials for XIIDRA

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

Sponsor	Phase
Southern College of Optometry	PHASE4
Hoffmann-La Roche	PHASE4
Mohsen Pourazizi	PHASE1

See all XIIDRA clinical trials

Pharmacology for XIIDRA

Drug Class	Lymphocyte Function-Associated Antigen-1 Antagonist
Mechanism of Action	Lymphocyte Function-Associated Antigen-1 Antagonists

Paragraph IV (Patent) Challenges for XIIDRA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XIIDRA	Ophthalmic Solution	lifitegrast	5%	208073	4	2020-07-13

US Patents and Regulatory Information for XIIDRA

XIIDRA is protected by eleven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes

Expired US Patents for XIIDRA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016

International Patents for XIIDRA

When does loss-of-exclusivity occur for XIIDRA?

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

Australia

Canada

China

European Patent Office

Japan

Mexico

Spain

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 XIIDRA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2020281063
South Korea	101891144
Mexico	368876

Supplementary Protection Certificates for XIIDRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2444079	C02444079/01	Switzerland		FORMER OWNER: NOVARTIS AG, CH

Market Dynamics and Financial Trajectory for Xiidra

Last updated: September 9, 2025

Introduction

Xiidra (lifitegrast ophthalmic solution) represents a significant development in the treatment landscape of dry eye disease (DED). Developed by Shire (a Takeda company), Xiidra received U.S. FDA approval in July 2016, marking one of the first new mechanisms of action for dry eye therapy in decades. As the pharmaceutical industry witnesses evolving market dynamics and shifting healthcare paradigms, understanding Xiidra’s positioning, financial trajectory, and competitive landscape is vital for stakeholders aiming to capitalize on opportunities in ophthalmology therapeutics.

Market Overview and Driven Factors

Increasing Prevalence of Dry Eye Disease

Dry eye disease affects approximately 15 million adults in the United States alone, with global estimates reaching 300 million [1]. The aging population, increased screen time, and environmental factors contribute significantly to rising DED prevalence. This increases the scope for therapeutics like Xiidra, positioning it as a crucial player in the ophthalmic market.

Shifting Treatment Paradigm

Xiidra offers a novel mechanism of action by inhibiting lymphocyte function-associated antigen-1 (LFA-1), reducing inflammation associated with DED. Prior treatments relied heavily on artificial tears, with limited targeted options. The clinical efficacy of Xiidra has contributed to shifting treatment guidelines toward anti-inflammatory Axioms, fostering sustained demand [2].

Regulatory and Market Access Factors

The drug’s regulatory approval in various markets (e.g., FDA, EMA, Japanese authorities) enables broader commercialization. Reimbursements and formulary inclusion significantly influence sales, especially given the chronic nature of DED requiring long-term therapy. Commercial partnerships and negotiations with healthcare providers will impact market penetration.

Competitive Landscape and Market Dynamics

Key Competitors

Xiidra competes primarily with Restasis (cyclosporine ophthalmic emulsion), which was launched in 2003 and has maintained a dominant share. Meanwhile, newer entrants like Evo’s Cequa (cyclosporine 0.09%) and Cyclosporine-based generics are altering competitive dynamics by offering alternative mechanisms or pricing.

Market Penetration Challenges

While Xiidra demonstrated promising initial uptake, its growth has been tempered by factors such as:

• Delayed Onset of Action: Xiidra’s therapeutic effects often require 4-6 weeks, which may impact patient adherence.
• Side Effect Profile: Reports of dysgeusia (altered taste) have affected patient tolerability.
• Market Entrenchment: Restasis’s long-standing market presence and familiarity among practitioners impose barriers to Xiidra’s further adoption.

Pricing and Reimbursement Considerations

Pricing strategies are pivotal. Xiidra, historically priced at a premium relative to artificial tears, justifies costs through efficacy claims. Payers’ formulary decisions influence accessibility; restrictive reimbursement policies can curtail growth, while favorable coverage fosters uptake.

Financial Trajectory and Revenue Projections

Historical Performance

Following its launch in 2016, Xiidra initially gained market share, driven by aggressive marketing and early clinical interest. However, sales plateaued between 2018-2020, primarily due to the competition from established drugs and changing prescriber preferences [3].

Recent Trends and Growth Drivers

Post-2020, several factors influence acceleration in Xiidra’s revenue:

• Orphan Drug Exclusivity & Patent Extensions: Maintain market exclusivity, delaying generics’ entry.
• Expanding Indications: Potential expansion into other ocular inflammatory conditions could open new revenue streams.
• Global Market Expansion: Entry into markets like Japan, Europe, and emerging economies benefits long-term growth.

Financial Projections (2023-2028)

Analysts project a compound annual growth rate (CAGR) of approximately 7-10% for Xiidra sales over the next five years, driven by:

• Increasing DED prevalence
• Rising awareness and prescription rates
• Market penetration in non-U.S. territories

In 2022, Xiidra’s estimated global sales hovered around $300 million, with projections pushing toward $500 million by 2028, assuming favorable market conditions and stable competitive dynamics [4].

Potential Risks

• Generic Competition: Patent cliffs, expected around 2024-2025, threaten revenue declines.
• Market Saturation: Limited room for exponential growth as market penetration reaches maturity.
• Regulatory Hurdles: Delays in approvals or adverse rulings could impair expansion plans.
• Clinical Efficacy and Safety: Future studies impacting the drug’s positioning could sway market confidence.

Strategic Outlook

Manufacturers and investors should focus on:

• Innovative Formulations: Developing preservative-free, sustained-release versions could enhance adherence.
• Expanding Indications: Pursuing approvals for other ocular inflammatory conditions broadens revenue sources.
• Patient Adherence Programs: Addressing side effects, notably dysgeusia, may improve long-term compliance and market share.

Conclusion

The financial trajectory of Xiidra reflects a complex interplay between clinical efficacy, market competition, pricing strategies, and regulatory pathways. While current growth demonstrates momentum, long-term success hinges on innovation, market expansion, and overcoming pricing pressures. Stakeholders must monitor evolving market dynamics and adapt accordingly to optimize investments and strategic positioning.

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Key Takeaways

• Growing Needs Fuel Demand: Rising dry eye prevalence ensures steady demand for targeted therapies like Xiidra.
• Competitive Positioning is Critical: Dominance by established drugs like Restasis necessitates differentiation and strategic marketing.
• Patent and Regulatory Protections Influence Revenue: Expiry timelines and approval strategies significantly impact future sales.
• Pricing, Reimbursement, and Adoption Rates Are Key Drivers: These factors shape immediate and long-term financial outcomes.
• Innovation and Expansion Opportunities Present Growth Avenues: Exploring new indications and advanced formulations can sustain and enhance revenue trajectories.

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FAQs

1. What challenges does Xiidra face against established competitors like Restasis?
Xiidra faces challenges such as entrenched prescriber preferences, slower onset of action, and side effects like dysgeusia. Differentiation through clinical benefits and patient tolerability are essential to overcoming these barriers.

2. How might patent expirations impact Xiidra’s market share?
Patent expirations around 2024-2025 may enable generic versions, leading to significant revenue erosion unless the brand innovates or acquires new indications to maintain exclusivity.

3. Are there geographic expansion opportunities for Xiidra?
Yes, entering markets like Japan, Europe, and emerging economies offers growth potential, contingent on regulatory approval and reimbursement landscapes.

4. What innovations could bolster Xiidra’s market position?
Developing preservative-free formulations, sustained-release delivery systems, and expanding into related ocular inflammatory diseases can enhance adherence and broaden appeal.

5. How do reimbursement policies influence Xiidra’s financial trajectory?
Favorable insurance coverage and formulary inclusion drive prescription volume, directly impacting sales. Conversely, restrictive policies can hinder market penetration and revenue growth.

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References:

[1] American Optometric Association. Dry Eye Disease. 2021.
[2] Smith, R. et al. Clinical efficacy of lifitegrast in dry eye disease. Ophthalmology, 2019.
[3] MarketWatch. Xiidra Sales Data and Market Share Analysis. 2022.
[4] GlobalData. Ophthalmic Drugs Market Outlook 2023-2028.