VEVYE Drug Patent Profile

When do Vevye patents expire, and what generic alternatives are available?

Vevye is a drug marketed by Harrow Eye and is included in one NDA. There are five patents protecting this drug.

This drug has eighty-five patent family members in nineteen countries.

The generic ingredient in VEVYE is cyclosporine. There are eighteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the cyclosporine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vevye

A generic version of VEVYE was approved as cyclosporine by HIKMA on October 29^th, 1999.

Summary for VEVYE

International Patents:	85
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VEVYE
What excipients (inactive ingredients) are in VEVYE?	VEVYE excipients list
DailyMed Link:	VEVYE at DailyMed

See drug prices for VEVYE

Pharmacology for VEVYE

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Cytochrome P450 3A4 Inhibitors P-Glycoprotein Inhibitors

US Patents and Regulatory Information for VEVYE

VEVYE is protected by three US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes			Y
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes			Y
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes			Y
Harrow Eye	VEVYE	cyclosporine	SOLUTION;OPHTHALMIC	217469-001	May 30, 2023		RX	Yes	Yes

International Patents for VEVYE

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

Country	Patent Number	Title	Estimated Expiration
Portugal	3356313
Australia	2022200366	SEMIFLUORINATED COMPOUNDS FOR OPHTHALMIC ADMINISTRATION
Japan	2022502421	乾性眼疾患の治療のための眼科用組成物
Spain	2965677
Portugal	2512515

Supplementary Protection Certificates for VEVYE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323

VEVYE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for VEVYE

Introduction

VEVYE, a water-free cyclosporine ophthalmic solution, has been making significant waves in the treatment of Dry Eye Disease (DED), a chronic condition affecting millions. Here, we delve into the market dynamics and financial trajectory of VEVYE, highlighting its clinical efficacy, market impact, and financial performance.

Clinical Efficacy and Safety

VEVYE has demonstrated remarkable long-term efficacy and safety in treating DED. The 52-week data from the ESSENCE-2 OLE study showed statistically significant improvements in key efficacy endpoints, including corneal staining, tear production, and symptomatology. This sustained safety and efficacy over 52 weeks underscore VEVYE's value in managing DED, with minimal adverse events reported, such as mild instillation site pain in only 6.5% of patients[1].

Market Impact

The clinical outcomes of VEVYE are highly promising for its market potential. As the first and only water-free cyclosporine ophthalmic solution, VEVYE offers a unique competitive edge. The high patient satisfaction rate of 91% and the product's ability to provide sustained relief with minimal adverse effects are likely to lead to wider adoption among eyecare professionals and patients. This could result in new revenue streams for Harrow and a potential paradigm shift in DED treatment protocols[1].

Insurance Coverage and Accessibility

VEVYE has secured comprehensive insurance coverage, which is crucial for its market penetration. Starting January 1, 2025, VEVYE will be covered under the Medicare Part D Prescription Drug Program, extending its reach to over 25 million Medicare Part D beneficiaries. Additionally, VEVYE has achieved 100% inclusion in U.S. Medicaid programs and 60% in commercial insurance plans, making it more accessible to patients with chronic DED[2].

Financial Performance

Harrow's financial performance has been robust, driven in part by the success of VEVYE. The company reported record quarterly revenue of $48.9 million, reflecting a 46% year-over-year growth. The inclusion of VEVYE in major insurance programs and its strong clinical data have significantly enhanced Harrow's revenue growth and market share expansion in the eyecare pharmaceutical sector[2].

Competitive Advantage

VEVYE's unique attributes, such as its water-free and preservative-free formulation, set it apart from existing treatments like RESTASIS®. The product's higher corneal penetration and twice-daily dosing with smaller dosage volumes contribute to higher patient compliance and potentially higher sales. This strategic differentiation provides Harrow with pricing power, enabling the company to maintain healthy profit margins[1].

Market Position and Growth Trajectory

Harrow's market momentum is strong, with a 50.06% increase in revenue over the last twelve months as of Q2 2024, reaching $154.15 million. The company's gross profit margin of 71.16% for the same period further supports its growth trajectory. Investors have shown confidence in Harrow's strategic moves, reflected in a 348.45% price total return over the past six months. While Harrow is not currently profitable, the expanded market access for VEVYE could potentially improve the company's financial outlook[2].

Analyst Insights and Projections

Analysts are optimistic about VEVYE's market potential. B. Riley upgraded their price target on Harrow Health shares to $73.00, citing the promising sales growth trajectory of its leading ophthalmic pharmaceutical brands, including VEVYE. The strong clinical data and comprehensive insurance coverage are expected to drive consistent revenue and potentially lead to profitability in the coming years[2].

Comparison with Other Market Players

In the broader context of the ophthalmic drugs market, VEVYE's success is part of a larger trend. The global ophthalmic drugs market is forecast to reach USD 51.46 billion by 2029, growing at a CAGR of 8.24% from 2024. This growth is driven by the increasing prevalence of eye-related disorders and advancements in drug development technologies. While companies like Roche and Regeneron are dominating the vascular endothelial growth factor A (VEGF-A) therapy market with products like Vabysmo and Eylea HD, VEVYE is carving out its own niche in the DED treatment market[5].

Key Takeaways

• Clinical Efficacy: VEVYE has shown significant long-term efficacy and safety in treating DED.
• Market Impact: The product's unique attributes and high patient satisfaction rate are expected to lead to wider adoption and new revenue streams.
• Insurance Coverage: Comprehensive coverage under Medicare Part D and other insurance programs enhances VEVYE's accessibility.
• Financial Performance: Harrow's revenue growth and market share expansion are driven by VEVYE's success.
• Competitive Advantage: VEVYE's water-free and preservative-free formulation sets it apart from competitors.
• Growth Trajectory: Strong market momentum and analyst optimism indicate a promising financial future for Harrow.

FAQs

Q: What makes VEVYE unique in the treatment of Dry Eye Disease? A: VEVYE is the first and only water-free cyclosporine ophthalmic solution, offering a unique competitive edge with its preservative-free formulation and higher corneal penetration[1].

Q: How has VEVYE's clinical data impacted its market potential? A: The 52-week data from the ESSENCE-2 OLE study showed statistically significant improvements in key efficacy endpoints, leading to high patient satisfaction and potential wider adoption among eyecare professionals and patients[1].

Q: What is the insurance coverage status for VEVYE? A: VEVYE is covered under the 2025 Medicare Part D Prescription Drug Program, U.S. Medicaid programs, and 60% of commercial insurance plans, making it highly accessible to patients[2].

Q: How has Harrow's financial performance been affected by VEVYE? A: Harrow reported record quarterly revenue and a significant year-over-year growth, driven in part by VEVYE's success and comprehensive insurance coverage[2].

Q: What are the analyst projections for Harrow's future financial outlook? A: Analysts are optimistic, with B. Riley upgrading their price target on Harrow Health shares, citing the promising sales growth trajectory of VEVYE and other leading ophthalmic pharmaceutical brands[2].

Sources

1. Harrow Announces 52-Week Data from VEVYE® ESSENCE-2 Open-Label Study - Stock Titan
2. Harrow Secures Medicare Coverage for Dry Eye Treatment VEVYE - Investing.com
3. Roche and Regeneron Square Off in Lucrative Eye Disease Market - BioSpace
4. Harrow Acquires US, Canadian Commercial Rights to VEVYE from Novaliq - Glance
5. Ophthalmic Drugs Market Size Research - Industry Trends & Share - Mordor Intelligence