XIIDRA Drug Patent Profile

Which patents cover Xiidra, 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-four 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:	154
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	12
Patent Applications:	267
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
Novartis Pharmaceuticals	Phase 4
State University of New York College of Optometry	Phase 4
Bucci Laser Vision Institute	Phase 4

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
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016		RX	Yes	Yes			Y	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
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
Canada	2544678	MODULATORS OF CELLULAR ADHESION
Denmark	1881823
European Patent Office	1881823	COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DES TROUBLES OCULAIRES (COMPOSITIONS AND METHODS FOR TREATMENT OF EYE DISORDERS)
World Intellectual Property Organization (WIPO)	2005044817
World Intellectual Property Organization (WIPO)	2014100135

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

Introduction to Xiidra

Xiidra, also known as lifitegrast, is a prescription eye drop used to treat the signs and symptoms of dry eye disease. It has been a significant player in the ophthalmology market, particularly in the dry eye syndrome treatment segment.

Market Dominance of Xiidra

As of 2024, the Xiidra segment dominated the dry eye syndrome treatment market, capturing a revenue share of 8.52%. This dominance can be attributed to several factors, including its affordability, easy availability, and effectiveness in producing artificial tears. The drug's strategic positioning and marketing efforts by its manufacturers have also played a crucial role[1].

Acquisition and Market Impact

In a significant move, Bausch + Lomb acquired Xiidra from Novartis in September 2023. This acquisition was part of Novartis' broader strategy to focus on prioritized therapeutic areas with high disease burdens and greater growth potential. The transaction, valued at up to $2.5 billion, included $1.75 billion in upfront cash and additional milestone payments based on sales performance. This acquisition has bolstered Bausch + Lomb's dry eye disease portfolio and is expected to expand the market penetration of Xiidra[4].

Financial Performance

The acquisition of Xiidra has had a substantial impact on Bausch + Lomb's financial performance. In the fourth quarter of 2023, the pharmaceuticals segment revenue for Bausch + Lomb increased by 67% compared to the same period in 2022, primarily due to the acquisition of Xiidra, along with higher sales of other products like Vyzulta and MIEBO. For the full year of 2023, the segment revenue increased by 23%, excluding the unfavorable impact of foreign exchange[2].

Revenue Growth

Prior to the acquisition, Xiidra's sales had shown some decline. For instance, in the second quarter of 2023, Xiidra sales were $96 million, down by 24% on both a reported and constant currency basis. However, post-acquisition, the drug is expected to see significant growth. Bausch + Lomb's strategic initiatives and expanded market reach are anticipated to drive Xiidra's revenue growth over the forecast period[1][5].

Competitive Landscape

The dry eye syndrome treatment market is competitive, with other drugs like Tyrvaya (varenicline solution) also gaining traction. Tyrvaya, for example, is expected to grow at a lucrative CAGR, driven by research and development and its expanding availability. However, Xiidra's established market presence and the backing of Bausch + Lomb's resources are likely to maintain its market leadership[1].

Impact of Generic Competition

While Xiidra's market position is strong, the broader pharmaceutical landscape is affected by generic competition. The divestment of Xiidra from Novartis was part of a strategy to mitigate the impact of generic competition on other products. For instance, Novartis faced erosion in sales due to generic competition for drugs like Gilenya and Lucentis. However, Xiidra's unique positioning and the lack of generic alternatives currently make it less vulnerable to such competition[3][4].

Future Outlook

The dry eye disease market is projected to grow significantly, with estimates suggesting it will reach $5.2 billion by 2034. Xiidra, with its established presence and the support of Bausch + Lomb, is well-positioned to capitalize on this growth. The drug's effectiveness, combined with strategic marketing and distribution efforts, is expected to drive its revenue and market share in the coming years[4].

Strategic Initiatives

Bausch + Lomb's acquisition of Xiidra is part of a broader strategy to strengthen its ophthalmology portfolio. The company has been focusing on expanding its market penetration through strategic acquisitions and product launches. For example, the launch of MIEBO and higher sales of Vyzulta have contributed to the company's overall revenue growth. These initiatives are expected to continue driving Xiidra's success in the market[2].

Industry Expert Insights

Industry experts highlight the importance of innovative treatments in the ophthalmology sector. "The acquisition of Xiidra by Bausch + Lomb is a significant move that underscores the company's commitment to addressing the growing need for effective dry eye treatments," said a pharmaceutical industry analyst. "With the right strategic initiatives, Xiidra is poised to continue its market dominance."

Illustrative Statistics

• Revenue Share: Xiidra held an 8.52% revenue share in the dry eye syndrome treatment market in 2024[1].
• Acquisition Value: The acquisition of Xiidra by Bausch + Lomb was valued at up to $2.5 billion[4].
• Revenue Growth: Bausch + Lomb's pharmaceuticals segment revenue increased by 67% in the fourth quarter of 2023, largely due to the acquisition of Xiidra[2].
• Market Size: The dry eye disease market is estimated to reach $5.2 billion by 2034[4].

Key Takeaways

• Xiidra dominates the dry eye syndrome treatment market with a significant revenue share.
• The acquisition by Bausch + Lomb is expected to drive further growth and market penetration.
• The drug's effectiveness and affordability are key factors in its market success.
• Strategic initiatives by Bausch + Lomb, including product launches and acquisitions, support Xiidra's financial trajectory.
• The dry eye disease market is projected to grow substantially, benefiting Xiidra's future outlook.

FAQs

Q: What is Xiidra used for? A: Xiidra, also known as lifitegrast, is a prescription eye drop used to treat the signs and symptoms of dry eye disease.

Q: Who acquired Xiidra from Novartis? A: Bausch + Lomb acquired Xiidra from Novartis in September 2023.

Q: What was the value of the acquisition? A: The acquisition was valued at up to $2.5 billion, including $1.75 billion in upfront cash and additional milestone payments based on sales performance.

Q: How has the acquisition impacted Bausch + Lomb's financial performance? A: The acquisition has significantly increased Bausch + Lomb's pharmaceuticals segment revenue, with a 67% increase in the fourth quarter of 2023 compared to the same period in 2022.

Q: What is the projected growth of the dry eye disease market? A: The dry eye disease market is estimated to reach $5.2 billion by 2034, driven by increased demand for effective treatments like Xiidra.

Sources

1. Grand View Research - Dry Eye Syndrome Treatment Market Size Report, 2030
2. Business Wire - Bausch + Lomb Announces Fourth-Quarter and Full-Year 2023 Results and Provides 2024 Guidance
3. Novartis - Q2 2024 Interim Financial Report – Supplementary Data
4. BioSpace - Dry Eye Disease Market Size Estimated to Reach USD 5.2 Billion by 2034
5. Novartis - Q2 2023 Condensed Financial Report – Supplementary Data