LIFITEGRAST - Generic Drug Details

What are the generic sources for lifitegrast and what is the scope of patent protection?

Lifitegrast is the generic ingredient in two branded drugs marketed by Eugia Pharma, Ingenus Pharms Llc, Micro Labs, and Bausch And Lomb Inc, and is included in four NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lifitegrast has one hundred and fifty-four patent family members in twenty-five countries.

Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LIFITEGRAST

International Patents:	154
US Patents:	16
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	18
Patent Applications:	398
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LIFITEGRAST
What excipients (inactive ingredients) are in LIFITEGRAST?	LIFITEGRAST excipients list
DailyMed Link:	LIFITEGRAST at DailyMed

Recent Clinical Trials for LIFITEGRAST

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

Sponsor	Phase
State University of New York College of Optometry	Phase 4
Novartis Pharmaceuticals	Phase 4
University of Waterloo	Phase 4

See all LIFITEGRAST clinical trials

Generic filers with tentative approvals for LIFITEGRAST

Applicant	Application No.	Strength	Dosage Form
		5%	SOLUTION/DROPS;OPHTHALMIC

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LIFITEGRAST

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

Anatomical Therapeutic Chemical (ATC) Classes for LIFITEGRAST

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for LIFITEGRAST

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

US Patents and Regulatory Information for LIFITEGRAST

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	AB	RX	Yes	Yes	9,216,174		Y
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AB	RX	Yes	Yes	8,927,574		Y
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AB	RX	Yes	Yes	8,168,655
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	AB	RX	Yes	Yes	8,084,047		Y	Y
Ingenus Pharms Llc	LIFITEGRAST	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	215058-001	Oct 3, 2024	AB	RX	No	No

Expired US Patents for LIFITEGRAST

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	10,124,000
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	9,216,174
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	7,928,122
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	7,745,460
Bausch And Lomb Inc	XIIDRA	lifitegrast	SOLUTION/DROPS;OPHTHALMIC	208073-001	Jul 11, 2016	7,790,743

International Patents for LIFITEGRAST

Country	Patent Number	Title	Estimated Expiration
Japan	2014132033	AEROSOLIZED LFA-1 ANTAGONISTS FOR USE IN LOCALIZED TREATMENT OF IMMUNE RELATED DISORDERS
Portugal	2934510
Hungary	E052299
Canada	2702984	COMPOSITIONS ET PROCEDES POUR LE TRAITEMENT DE LA RETINOPATHIE DIABETIQUE (COMPOSITIONS AND METHODS FOR TREATMENT OF DIABETIC RETINOPATHY)
Hong Kong	1210782	抑制劑及其多晶型物 (LFA-1 INHIBITOR AND POLYMORPH THEREOF LFA-1)

Supplementary Protection Certificates for LIFITEGRAST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2444079	C02444079/01	Switzerland		PRODUCT NAME: LIFITEGRAST; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66850 19.12.2018

LIFITEGRAST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lifitegrast (Xiidra)

Introduction to Lifitegrast

Lifitegrast, marketed under the brand name Xiidra, is a lymphocyte function-associated antigen-1 (LFA-1) antagonist developed to treat the signs and symptoms of dry eye disease (DED). It was approved by the FDA in July 2016 and launched in August of the same year.

Market Entry and Initial Performance

Since its launch, lifitegrast has shown significant market traction. By February 2017, it had generated $54 million in sales, capturing 19% of the U.S. dry eye market share. This strong start was marked by over 270,000 prescriptions written in just four months, with lifitegrast maintaining 20% of the total market and 50% of new patients entering the market[1].

Sales Growth and Market Share

The first-quarter 2017 report for Shire, the company behind lifitegrast, highlighted continued growth. The drug contributed $38.6 million in total product sales, increasing Shire's ophthalmology franchise revenue. By March 2017, lifitegrast had acquired 22% of the U.S. market share, building on its initial success[3].

Global Expansion

Shire's strategy included expanding lifitegrast's reach beyond the U.S. market. The company filed for approval in Canada and planned to file in Europe during the third quarter of 2017, aiming to capitalize on the global demand for dry eye treatments[1][3].

Clinical Efficacy and Patient Impact

Lifitegrast's efficacy was demonstrated in several clinical trials, including the OPUS-3 phase III study. This study showed that lifitegrast significantly improved symptoms of eye dryness, as measured by the eye dryness score (EDS), compared to placebo. Improvements were observed as early as day 14, and the drug was found to be well-tolerated with no serious ocular adverse events reported[2].

Market Dynamics and Competition

The global dry eye syndrome therapeutics market is projected to reach $7.8 billion by 2031, growing at a CAGR of 4.5%. Lifitegrast is anticipated to grow at a lucrative rate within this market, driven by its unique mechanism of action as an LFA-1 antagonist. However, the market is also expected to see competition from other treatments, including generic versions of existing drugs like Restasis by Mylan Pharmaceuticals[4].

Financial Performance of Shire

The launch of lifitegrast was a significant contributor to Shire's financial performance. In 2016, Shire reported a record high revenue of $10.9 billion, driven in part by the acquisition of Baxalta and the strong sales of lifitegrast. The company's first-quarter 2017 revenue was $3.57 billion, up 109% from the same period the previous year, with lifitegrast playing a key role in this growth[1][3].

Economic and Quality of Life Impact

Dry eye disease imposes a significant economic burden and affects patients' quality of life. In Canada, the total cost of DED, including both direct and indirect costs, is estimated at over $24,000 CAD annually per patient. Effective treatments like lifitegrast can help mitigate these costs and improve patients' health status and quality of life[5].

Competitive Landscape

While lifitegrast has been a market leader, other treatments are emerging. For example, a matching-adjusted indirect comparison suggested that OC-01 VNS (varenicline solution) might provide greater improvement in dry eye symptoms compared to lifitegrast. However, lifitegrast remains a significant player due to its unique mechanism and established market presence[5].

Future Outlook

The future outlook for lifitegrast is promising, despite potential competition. The drug's unique mechanism and its position as the first LFA-1 antagonist approved for DED treatment are expected to continue driving its growth. However, the entry of generic competitors and new treatments may impact its market share and revenue in the coming years[4].

Key Takeaways

• Strong Market Entry: Lifitegrast captured 19% of the U.S. dry eye market share within months of its launch.
• Global Expansion: Plans for approval in Canada and Europe aim to expand its global reach.
• Clinical Efficacy: Significant improvement in dry eye symptoms and well-tolerated profile.
• Financial Impact: Contributed to Shire's record high revenue in 2016 and continued growth in 2017.
• Market Dynamics: Part of a growing global dry eye therapeutics market, but faces competition from generics and new treatments.
• Economic and Quality of Life Impact: Helps mitigate the economic burden and improves quality of life for DED patients.

FAQs

What is lifitegrast and how does it work?

Lifitegrast, marketed as Xiidra, is a lymphocyte function-associated antigen-1 (LFA-1) antagonist that reduces inflammation in dry eye disease (DED). It works by blocking the interaction between LFA-1 and its ligand, ICAM-1, thereby reducing inflammation and improving symptoms of DED.

How successful was the launch of lifitegrast?

The launch of lifitegrast was highly successful, with $54 million in sales within the first few months, capturing 19% of the U.S. dry eye market share and generating over 270,000 prescriptions.

What are the key clinical findings for lifitegrast?

Clinical trials, such as the OPUS-3 study, showed that lifitegrast significantly improved symptoms of eye dryness, as measured by the eye dryness score (EDS), compared to placebo, with improvements observed as early as day 14.

How does lifitegrast fit into the global dry eye therapeutics market?

Lifitegrast is part of a growing global dry eye therapeutics market projected to reach $7.8 billion by 2031. It is expected to grow at a lucrative rate due to its unique mechanism but faces competition from generics and new treatments.

What is the economic impact of dry eye disease, and how does lifitegrast help?

Dry eye disease imposes a significant economic burden, estimated at over $24,000 CAD annually per patient in Canada. Lifitegrast helps mitigate these costs by effectively treating DED symptoms, improving patients' health status and quality of life.

Are there any emerging competitors to lifitegrast?

Yes, treatments like OC-01 VNS (varenicline solution) have shown potential in clinical trials, suggesting they might provide greater improvement in dry eye symptoms compared to lifitegrast. However, lifitegrast remains a significant player due to its established market presence and unique mechanism.

Sources

1. American Academy of Ophthalmology - Lifitegrast sales off to strong start[1].
2. PubMed - Lifitegrast for the Treatment of Dry Eye Disease[2].
3. American Academy of Ophthalmology - Lifitegrast sales continue to grow[3].
4. iHealthcareAnalyst - Global Dry Eye Syndrome Therapeutics Market[4].
5. Journal of Managed Care & Specialty Pharmacy - Matching-adjusted indirect comparison of phase 3 clinical trial data[5].