MYDCOMBI Drug Patent Profile

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

Mydcombi is a drug marketed by Eyenovia and is included in one NDA. There are three patents protecting this drug.

This drug has forty-four patent family members in fourteen countries.

The generic ingredient in MYDCOMBI is phenylephrine hydrochloride; tropicamide. There are twenty-one drug master file entries for this compound. Additional details are available on the phenylephrine hydrochloride; tropicamide profile page.

DrugPatentWatch^® Generic Entry Outlook for Mydcombi

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 5, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MYDCOMBI

International Patents:	44
US Patents:	3
Applicants:	1
NDAs:	1
What excipients (inactive ingredients) are in MYDCOMBI?	MYDCOMBI excipients list
DailyMed Link:	MYDCOMBI at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MYDCOMBI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

215352

Dosage:

SPRAY, METERED;OPHTHALMIC

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for MYDCOMBI

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

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	11,398,306
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	10,839,960
Eyenovia	MYDCOMBI	phenylephrine hydrochloride; tropicamide	SPRAY, METERED;OPHTHALMIC	215352-001	May 5, 2023		DISCN	Yes	No	11,839,487

International Patents for MYDCOMBI

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

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	201390121
Japan	6408504
Japan	2018153667	滴生成デバイス (DROP GENERATING DEVICE)
South Africa	201301155	OPHTHALMIC DRUG DELIVERY
South Korea	20150031340	OPHTHALMIC DRUG DELIVERY
South Korea	20170129298	안과용 약물 전달 (OPHTHALMIC DRUG DELIVERY)
World Intellectual Property Organization (WIPO)	2012009706

Supplementary Protection Certificates for MYDCOMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	92923	Luxembourg		PRODUCT NAME: UNE SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; FIRST REGISTRATION: 20150730

Market Dynamics and Financial Trajectory for Mydcombi

Introduction

Mydcombi, developed by Eyenovia Inc., is a groundbreaking ophthalmic product that has recently entered the market, marking a significant milestone in the field of ophthalmology. This article delves into the market dynamics and financial trajectory of Mydcombi, highlighting its potential, challenges, and the company's strategic plans.

FDA Approval and Commercial Launch

Mydcombi, a fixed combination of tropicamide and phenylephrine hydrochloride ophthalmic spray, received FDA approval on May 8, 2023. This approval was a crucial step towards its commercialization, which began with the first commercial sale in August 2023[4].

Market Opportunity

Mydcombi addresses a substantial market need, particularly in the context of pupil dilation for comprehensive eye exams and surgical procedures. With over 106 million office-based comprehensive eye exams performed annually in the U.S., Mydcombi is poised to streamline these procedures by offering a more convenient and efficient method of pupil dilation[4].

Competitive Advantage

Mydcombi is the first FDA-approved fixed combination of tropicamide and phenylephrine, and it utilizes Eyenovia's proprietary Optejet dispensing platform. This technology provides a metered spray delivery, which is more user-friendly and potentially safer compared to conventional multiple eye drops. This unique selling proposition is expected to capture a significant share of the mydriasis market[4].

Commercial Expansion

Eyenovia has been actively expanding the reach of Mydcombi. As of the third quarter of 2024, Mydcombi has been introduced to 230 new offices, and the company has secured commercial licenses for sale in 16 states, representing more than half of the U.S. targeted population[2][3].

Sales and Marketing Strategy

Eyenovia has hired, trained, and deployed a field sales force to promote Mydcombi. The company has also entered into a co-promotion agreement with NovaBay, which will help in reaching a broader audience of eye care professionals. This strategic partnership is expected to enhance the sales of Mydcombi by leveraging NovaBay's extensive network[3].

Financial Performance

Despite the promising market potential, Eyenovia's financial results for 2024 reflect ongoing challenges. The company reported a net loss of $7.9 million in the third quarter of 2024, compared to a net loss of $7.3 million in the same period of 2023. Operating expenses increased by 10.6% to $7.2 million, with significant contributions from research and development and selling, general, and administrative expenses[2][5].

Revenue Projections

While Mydcombi has just begun its commercial journey, Eyenovia is optimistic about its revenue potential. The company anticipates meaningful sales growth over the next 18 months, driven by the commercialization of Mydcombi and another FDA-approved product, clobetasol propionate ophthalmic suspension. These products are expected to leverage the existing sales force and contribute significantly to the company's revenue[1][3].

Cash Runway and Funding

Eyenovia is currently evaluating long-term financing options due to its low cash position of $7.2 million. The company has generated $16 million in license fees from Arctic Vision and may receive an additional $25 million in milestones plus sales royalties. These financial arrangements are crucial for supporting the company's corporate strategy and product development[2][3].

Strategic Partnerships

Eyenovia is actively exploring strategic partnerships to expedite the development and commercialization of its products. The collaboration with NovaBay and Vision Source, along with the reacquisition of MicroPine rights, underscores the company's commitment to expanding its product portfolio and enhancing its market presence[3].

Future Outlook

The future of Mydcombi looks promising, with several factors contributing to its potential success:

• Market Size: The mydriasis market, particularly in the context of comprehensive eye exams and cataract surgeries, is substantial.
• Unique Technology: The Optejet platform offers a differentiated delivery method that could capture a mid-single digit market share over the next few years.
• Strategic Partnerships: Collaborations with NovaBay and Vision Source are expected to boost sales and reach a broader audience.
• Regulatory Pathway: Plans to engage with the FDA for additional indications, such as dry eye treatment, could further expand Mydcombi's market potential[3].

"Eyenovia is actively exploring options to expedite the development and registration of MicroPine. The company is maintaining MicroLine in their portfolio for potential future use. They are evaluating options to increase cash resources for funding their corporate strategy."[3]

Key Takeaways

• FDA Approval: Mydcombi received FDA approval in May 2023 and began commercial sales in August 2023.
• Market Opportunity: Addresses a significant market need in pupil dilation for eye exams and surgeries.
• Competitive Advantage: Utilizes Eyenovia's proprietary Optejet dispensing platform.
• Commercial Expansion: Introduced to 230 new offices and licensed for sale in 16 states.
• Financial Performance: Reported net losses but anticipates meaningful sales growth.
• Strategic Partnerships: Collaborations with NovaBay and Vision Source to enhance sales.
• Future Outlook: Promising market potential with plans for additional indications.

FAQs

What is Mydcombi and how does it work?

Mydcombi is a fixed combination of tropicamide and phenylephrine hydrochloride ophthalmic spray, approved by the FDA for pupil dilation. It uses Eyenovia's proprietary Optejet dispensing platform, providing a metered spray delivery.

When did Mydcombi receive FDA approval?

Mydcombi received FDA approval on May 8, 2023.

What is the market potential for Mydcombi?

Mydcombi addresses a substantial market need, particularly in comprehensive eye exams and cataract surgeries, with over 106 million office-based exams performed annually in the U.S.

How is Eyenovia expanding the reach of Mydcombi?

Eyenovia has introduced Mydcombi to 230 new offices and secured commercial licenses for sale in 16 states. The company has also entered into co-promotion agreements with NovaBay and Vision Source.

What are the financial challenges facing Eyenovia?

Eyenovia reported a net loss of $7.9 million in the third quarter of 2024 and is evaluating long-term financing options due to its low cash position.

What are the future plans for Mydcombi?

Eyenovia plans to engage with the FDA for additional indications, such as dry eye treatment, and is exploring strategic partnerships to expedite product development and commercialization.

Sources

1. Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on Its Myopia Phase III Program and Its Two FDA-Approved Commercial Products, Mydcombi and Clobetasol. BioSpace.
2. Eyenovia Reports Third Quarter 2024 Financial Results and Provides Updates. Stock Titan.
3. Earnings call: Eyenovia outlines strategic plans and financials for 2023. Investing.com.
4. Eyenovia Announces First Commercial Sale of Mydcombi. BioSpace.
5. Eyenovia Reports Third Quarter 2024 Financial Results and Provides Updates. Eyenovia Investor Relations.