EYSUVIS Drug Patent Profile

Which patents cover Eysuvis, and what generic alternatives are available?

Eysuvis is a drug marketed by Alcon Labs Inc and is included in one NDA. There are seventeen patents protecting this drug.

This drug has eighty-four patent family members in twelve countries.

The generic ingredient in EYSUVIS is loteprednol etabonate. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the loteprednol etabonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Eysuvis

A generic version of EYSUVIS was approved as loteprednol etabonate by SENTISS on April 17^th, 2019.

Summary for EYSUVIS

International Patents:	84
US Patents:	17
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	1
Patent Applications:	4,594
Drug Prices:	Drug price information for EYSUVIS
What excipients (inactive ingredients) are in EYSUVIS?	EYSUVIS excipients list
DailyMed Link:	EYSUVIS at DailyMed

See drug prices for EYSUVIS

Recent Clinical Trials for EYSUVIS

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

Sponsor	Phase
Price Vision Group	Phase 4
Kala Pharmaceuticals, Inc.	Phase 4

See all EYSUVIS clinical trials

Pharmacology for EYSUVIS

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for EYSUVIS

EYSUVIS is protected by seventeen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y
Alcon Labs Inc	EYSUVIS	loteprednol etabonate	SUSPENSION/DROPS;OPHTHALMIC	210933-001	Oct 26, 2020		RX	Yes	Yes			Y

International Patents for EYSUVIS

See the table below for patents covering EYSUVIS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2871748	NANOPARTICULES PHARMACEUTIQUES A TRANSPORT MUCOSAL AMELIORE (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
China	111700878	显示提高的粘膜转移的药物纳米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
China	111700880	显示提高的粘膜转移的药物纳米粒子 (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT)
Mexico	2020007227	NANOPARTICULAS FARMACEUTICAS QUE MUESTRAN LA MEJORA DEL TRANSPORTE DE LA MUCOSA. (PHARMACEUTICAL NANOPARTICLES SHOWING IMPROVED MUCOSAL TRANSPORT.)
New Zealand	741873	Pharmaceutical nanoparticles showing improved mucosal transport
World Intellectual Property Organization (WIPO)	2013166385

Market Dynamics and Financial Trajectory for EYSUVIS

Introduction

EYSUVIS, a loteprednol etabonate ophthalmic suspension 0.25%, is a key product in Kala Pharmaceuticals' portfolio, specifically designed for the treatment of dry eye disease. Here, we delve into the market dynamics and financial trajectory of EYSUVIS, highlighting its performance, market trends, and future outlook.

Market Context: Dry Eye Medication

The dry eye medication market is experiencing rapid growth, driven by factors such as an aging population, increased use of contact lenses, higher disposable income, and a rise in the prevalence of allergies and diabetes mellitus. The market is projected to grow from $9.74 billion in 2023 to $10.93 billion in 2024, with a compound annual growth rate (CAGR) of 12.2%, and is expected to reach $16.93 billion by 2028 at a CAGR of 11.6%[3].

Product Launch and Initial Performance

EYSUVIS was launched in January 2021, marking a significant milestone for Kala Pharmaceuticals. In the first quarter of 2022, EYSUVIS prescriptions showed an 18% quarter-over-quarter growth, with 26,518 prescriptions filled. This growth continued into the second quarter of 2022, indicating strong market acceptance[1].

Prescription Growth and Market Penetration

As of May 2022, over 103,514 EYSUVIS prescriptions had been filled since its launch, including more than 17,955 refill prescriptions, written by over 8,200 unique prescribers. This robust prescription growth underscores the product's increasing market penetration and acceptance among healthcare providers[1].

Coverage and Access

Kala Pharmaceuticals has been actively expanding the coverage for EYSUVIS. By the first quarter of 2022, EYSUVIS had achieved coverage for 92% of total commercial lives and 30% of all Medicare lives. This expanded coverage is expected to reduce the impact of patient assistance programs on the average selling price and net revenue in the future[1].

Financial Performance

For the full year ended December 31, 2021, Kala reported net product revenues of $11.2 million, with $6.3 million attributed to EYSUVIS sales. This represents a significant increase from the $0.3 million in net revenues from EYSUVIS in 2020, primarily due to the full commercial launch of the product in January 2021[2].

Impact of Patient Assistance Programs

While patient assistance programs have helped ensure prescriptions are filled, they have also negatively impacted net revenues. However, with the recent expansion in payor coverage, Kala expects these programs to have less of an impact on the average selling price and net revenue moving forward[1].

Competitive Landscape

The ophthalmic drugs market, particularly the segment for dry eye treatments, is highly competitive. The branded drugs segment, which includes EYSUVIS, accounted for the largest share in 2023. However, the generic drugs segment is expected to show the fastest growth due to the expiry of branded drug patents and the cost-effectiveness of generic alternatives[4].

Future Outlook

Kala Pharmaceuticals continues to focus on expanding formulary coverage and engaging in contract discussions with other health plans to further increase EYSUVIS's market reach. The company's strategy to enhance patient access and reduce the financial burden through expanded coverage is expected to drive continued growth for EYSUVIS[1].

Clinical Pipeline and Expansion

In addition to its commercial success, Kala is progressing with the development of other ocular treatments, such as KPI-012, which has broad potential for treating persistent corneal epithelial defect (PCED) and other rare ocular diseases. The initiation of a Phase 2/3 clinical trial for KPI-012 later in the year, subject to regulatory clearance, indicates a promising pipeline that could further bolster Kala's market position[1].

Key Takeaways

• Rapid Market Growth: EYSUVIS operates in a rapidly growing dry eye medication market.
• Strong Prescription Growth: EYSUVIS has shown significant quarter-over-quarter prescription growth since its launch.
• Expanded Coverage: Coverage for EYSUVIS has been expanded to 92% of commercial lives and 30% of Medicare lives.
• Financial Impact: Patient assistance programs have temporarily impacted net revenues, but expanded coverage is expected to mitigate this effect.
• Competitive Landscape: The branded segment, including EYSUVIS, dominates the market, but generic alternatives are gaining traction.
• Future Outlook: Continued focus on expanding coverage and a promising clinical pipeline are expected to drive future growth.

FAQs

What is EYSUVIS used for?

EYSUVIS is used for the treatment of dry eye disease.

How has EYSUVIS performed since its launch?

EYSUVIS has shown an 18% quarter-over-quarter growth in prescriptions since its launch in January 2021, with over 103,514 prescriptions filled as of May 2022.

What is the current market coverage for EYSUVIS?

As of the first quarter of 2022, EYSUVIS has achieved coverage for 92% of total commercial lives and 30% of all Medicare lives.

How have patient assistance programs affected EYSUVIS revenues?

Patient assistance programs have temporarily negatively impacted net revenues, but with expanded coverage, this impact is expected to decrease.

What are Kala Pharmaceuticals' future plans for EYSUVIS and other products?

Kala plans to continue expanding formulary coverage for EYSUVIS and is progressing with the development of other ocular treatments, such as KPI-012, which is set to enter a Phase 2/3 clinical trial later in the year.

Sources

1. Kala Pharmaceuticals - Kala Reports First Quarter 2022 Financial Results and Provides Corporate Update.
2. GlobeNewswire - Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update.
3. Research and Markets - Dry Eye Medication Market Report 2024.
4. Grand View Research - U.S. Ophthalmic Drugs Market Size | Industry Report, 2030.