VERKAZIA Drug Patent Profile

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

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

This drug has one hundred and fifteen patent family members in twenty-three countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Verkazia

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

Summary for VERKAZIA

International Patents:	115
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Patent Applications:	4,423
Drug Prices:	Drug price information for VERKAZIA
What excipients (inactive ingredients) are in VERKAZIA?	VERKAZIA excipients list
DailyMed Link:	VERKAZIA at DailyMed

See drug prices for VERKAZIA

Pharmacology for VERKAZIA

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

US Patents and Regulatory Information for VERKAZIA

VERKAZIA is protected by seven 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	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes			Y
Harrow Eye	VERKAZIA	cyclosporine	EMULSION;OPHTHALMIC	214965-001	Jun 23, 2021		RX	Yes	Yes

International Patents for VERKAZIA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008012367
China	103356481	Ophthalmic emulsions containing immunosuppressive agent
European Patent Office	1827373	ÉMULSIONS OPHTALMIQUES CONTENANT DES PROSTAGLANDINES (OPHTHALMIC EMULSIONS CONTAINING PROSTAGLANDINS)
Hong Kong	1112411	OPHTHALMIC EMULSIONS CONTAINING AN IMMUNOSUPPRESSIVE AGENT

Supplementary Protection Certificates for VERKAZIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1809237	300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP EMULSION); REGISTRATION NO/DATE: EU/1/15/990 20150323
2049079	LUC00006	Luxembourg		PRODUCT NAME: CYCLOSPORINE (GOUTTES OCULAIRES SOUS FORME D'EMULSION); AUTHORISATION NUMBER AND DATE: EU/1/15/990 20150323
1809237	C300741	Netherlands		PRODUCT NAME: CICLOSPORINE (EYE DROP; REGISTRATION NO/DATE: EU/1/15/990 20150319
1809237	C01809237/01	Switzerland		PRODUCT NAME: CICLOSPORIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66093 08.09.2016

Market Dynamics and Financial Trajectory for Verkazia

Introduction to Verkazia

Verkazia, a treatment for vernal keratoconjunctivitis (VKC), is a significant player in the ophthalmic pharmaceutical market. Developed by Santen Pharmaceutical, Verkazia has been making strides in addressing the needs of patients suffering from this chronic and severe allergic eye disease.

Market Overview

The global VKC market, within which Verkazia operates, is projected to grow substantially. According to market forecasts, the VKC market is expected to reach USD 782.42 million by 2033, growing at a CAGR of 6% from 2023 to 2033[1].

Product Launch and Market Uptake

Verkazia was launched in May 2022, marking a significant milestone for Santen Pharmaceutical. The drug's introduction has been part of the company's strategy to expand its product portfolio and address unmet medical needs in the ophthalmic sector. The market uptake of Verkazia has been positive, contributing to the overall growth of the VKC market[3].

Competitive Landscape

Verkazia operates in a competitive market with other treatments such as bertilimumab, lodoxamide, tacrolimus, and nomacopan. However, its unique positioning and efficacy have allowed it to capture a significant market share. Key companies like Allakos, iCo Therapeutics, Akari Therapeutics, and Santen are major players in this market, with Santen's Verkazia being a notable product[1].

Distribution Channels

Hospital pharmacies account for the largest market share in the distribution of VKC treatments, including Verkazia. This is due to the specialized nature of the treatment and the need for professional oversight. Retail and online pharmacies also play a role, but hospital pharmacies remain the dominant channel[1].

Regional Market Performance

North America is expected to possess a 20% market share for the VKC market, which includes Verkazia. This region is a key market for ophthalmic treatments due to high healthcare spending and a strong presence of pharmaceutical companies. Europe, Asia Pacific, and other regions also contribute significantly to the market[1].

Financial Performance of Santen Pharmaceutical

Santen Pharmaceutical, the developer of Verkazia, has shown strong financial performance in recent years. For FY2023, Santen achieved its highest revenue at JPY 302.0 billion, with a core operating profit of JPY 62.8 billion, representing a 41.9% year-over-year increase. The company has completed structural reforms, including streamlining operations in the Americas, which has improved profitability by JPY 15.0 billion[5].

Growth Strategy and Outlook

Santen's medium-to-long-term growth strategy includes pursuing commercial excellence, expanding its product pipeline, and improving profitability. The company aims to increase its operating profit ratio and reduce the effective tax rate to the low 20% range by fiscal 2025. Verkazia is a key component of this strategy, contributing to the company's revenue and profit growth[3][5].

Research and Development

Santen continues to invest in research and development, which is crucial for the long-term success of Verkazia and other products. The company has made progress in areas such as myopia and ptosis, and has approved new products like Alesion eyelid cream and Catiolanze in various regions[5].

Environmental and Social Responsibility

Santen has also emphasized environmental and social responsibility, aligning with its "Santen Vision for the Earth 2050." This includes targets related to climate change and reducing the company's environmental footprint, which can positively impact its brand and market position[3].

Key Takeaways

• Market Growth: The VKC market, including Verkazia, is expected to grow at a CAGR of 6% from 2023 to 2033.
• Product Uptake: Verkazia has seen positive market uptake since its launch.
• Distribution: Hospital pharmacies are the primary distribution channel.
• Financial Performance: Santen Pharmaceutical has shown strong financial results, with significant increases in revenue and operating profit.
• Growth Strategy: Verkazia is integral to Santen's growth strategy, focusing on commercial excellence and product pipeline expansion.

FAQs

Q: What is Verkazia used for? A: Verkazia is used to treat vernal keratoconjunctivitis (VKC), a chronic and severe allergic eye disease.

Q: Who developed Verkazia? A: Verkazia was developed by Santen Pharmaceutical.

Q: What is the projected market size for the VKC market by 2033? A: The VKC market is expected to reach USD 782.42 million by 2033.

Q: What is the primary distribution channel for Verkazia? A: Hospital pharmacies account for the largest market share in the distribution of Verkazia.

Q: How has Santen Pharmaceutical's financial performance been in recent years? A: Santen Pharmaceutical has shown strong financial performance, with significant increases in revenue and operating profit, and has completed structural reforms to improve profitability.

Cited Sources

1. Future Market Insights: Vernal Keratoconjunctivitis Market - Size, Trends & Forecast.
2. Harrow, Inc.: Letter to Stockholders - Investor Relations.
3. Santen Pharmaceutical: Strategy - Santen Pharmaceutical.
4. PR Newswire: Global Vernal Keratoconjunctivitis (VKC) Industry Insights 2017-2030.
5. Santen Pharmaceutical: FY2023 Financial Results - Santen Pharmaceutical.