RYZUMVI Drug Patent Profile

Which patents cover Ryzumvi, and when can generic versions of Ryzumvi launch?

Ryzumvi is a drug marketed by Famygen Life Sci and is included in one NDA. There are eight patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in sixteen countries.

The generic ingredient in RYZUMVI is phentolamine mesylate. There are four drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the phentolamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ryzumvi

A generic version of RYZUMVI was approved as phentolamine mesylate by HIKMA on March 11^th, 1998.

Summary for RYZUMVI

International Patents:	24
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in RYZUMVI?	RYZUMVI excipients list
DailyMed Link:	RYZUMVI at DailyMed

Pharmacology for RYZUMVI

Drug Class	alpha-Adrenergic Blocker
Mechanism of Action	Adrenergic alpha-Antagonists

Paragraph IV (Patent) Challenges for RYZUMVI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZUMVI	Ophthalmic Solution	phentolamine mesylate	0.75%	217064	1	2024-12-16

US Patents and Regulatory Information for RYZUMVI

RYZUMVI is protected by eight 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
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes			Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes			Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes			Y
Famygen Life Sci	RYZUMVI	phentolamine mesylate	SOLUTION;OPHTHALMIC	217064-001	Sep 25, 2023		RX	Yes	Yes

International Patents for RYZUMVI

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

Country	Patent Number	Title	Estimated Expiration
Canada	3116589	METHODES ET COMPOSITIONS POUR LE TRAITEMENT DE LA PRESBYTIE, DE LA MYDRIASE ET D'AUTRES TROUBLES OCULAIRES (METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS)
China	113164452	治疗老花眼、散瞳和其他眼部疾病的方法和组合物 (METHODS AND COMPOSITIONS FOR TREATMENT OF PRESBYOPIA, MYDRIASIS, AND OTHER OCULAR DISORDERS)
Japan	2016506966	フェントラミンの水性点眼液およびそれらの医学的用途
Portugal	2950648
Spain	2762153

Market Dynamics and Financial Trajectory for RYZUMVI

Introduction to RYZUMVI

RYZUMVI, also known as phentolamine ophthalmic solution, is a recently approved drug by the FDA for the treatment of pharmacologically-induced mydriasis, or dilation of the pupils. Developed by Ocuphire Pharma and commercialized by Viatris Inc., this drug addresses a significant unmet medical need in the ophthalmic sector[4].

Market Need and Potential

The market for RYZUMVI is substantial, given that approximately 100 million comprehensive eye exams involving pharmacologically induced dilation of the pupils take place annually in the U.S. These exams often result in prolonged dilation, leading to side effects such as sensitivity to light and blurred vision. RYZUMVI's ability to reverse this dilation quickly could significantly improve patient outcomes and quality of life[4].

Clinical Trials and Approval

The FDA approval of RYZUMVI was based on the MIRA clinical trial program, which included multiple phase 2 and 3 trials. These trials demonstrated the efficacy of RYZUMVI in returning pupils to their baseline diameter, with statistically significant results compared to placebo. Common side effects included instillation site discomfort and conjunctival hyperemia, but overall, the trials supported the drug's safety and efficacy[4].

Commercial Launch and Partnership

The commercial launch of RYZUMVI in the U.S. was announced in April 2024, marking a significant milestone for both Ocuphire Pharma and Viatris Inc. The partnership between these companies is strategic, leveraging Viatris's extensive commercial infrastructure and sales force in ophthalmology to expand the market reach of RYZUMVI[1].

Financial Implications for Ocuphire Pharma

The commercialization of RYZUMVI is expected to have a substantial financial impact on Ocuphire Pharma. The deal structure includes milestones and royalties, which can provide non-dilutive funding and a continuous income source. As of March 31, 2024, Ocuphire had $47.2 million in cash, with positive revenue from collaborations and royalties. However, the company also faced increased general and administrative expenses, resulting in a net loss of $7.1 million for the first quarter of 2024[2].

Viatris's Role and Financial Outlook

Viatris Inc. plays a crucial role in the commercialization of RYZUMVI. The company reported strong financial results for 2023, with total revenues of $15.4 billion and an adjusted EBITDA of $5.1 billion. Viatris anticipates a revenue growth of approximately 2% in 2024 and expects its eye care portfolio, including RYZUMVI, to contribute significantly to this growth. The company aims to reach $1 billion in eye care sales by 2028, with RYZUMVI being a key product in achieving this goal[3].

Market Strategy and Challenges

Ocuphire Pharma's decision to prioritize cash-pay utilization for RYZUMVI could have mixed outcomes. While this strategy offers pricing and marketing liberties, it also faces potential price competition and market resistance. The success of RYZUMVI will depend on the effectiveness of the marketing strategy, the competitive landscape, and the drug's reception by healthcare professionals and patients[5].

Competitive Landscape

The ophthalmic market is competitive, with various treatments available for eye disorders. RYZUMVI's unique selling proposition lies in its ability to reverse pharmacologically-induced mydriasis quickly, which could differentiate it from other treatments. However, the drug will still need to compete with existing products and potentially new entrants in the market[4].

Regulatory Considerations

The pharmaceutical industry is heavily regulated, and compliance is crucial for the successful commercialization of RYZUMVI. Viatris's expertise and track record in handling regulatory matters will be critical in navigating these challenges and ensuring the drug's continued market presence[1].

Future Growth Potential

The launch of RYZUMVI presents a significant growth opportunity for both Ocuphire Pharma and Viatris Inc. With a strong pipeline and strategic collaborations, Viatris is well-positioned to drive future growth. Ocuphire Pharma's long-term revenue potential remains promising, particularly as the company's commercial agreements and clinical results mature[2].

Key Takeaways

• Market Need: RYZUMVI addresses a significant unmet medical need in the ophthalmic sector, with a large potential market.
• Clinical Efficacy: The drug has demonstrated efficacy in clinical trials, with FDA approval based on the MIRA clinical trial program.
• Commercial Partnership: The partnership with Viatris Inc. is strategic, leveraging Viatris's commercial infrastructure to expand market reach.
• Financial Impact: The commercialization of RYZUMVI is expected to have a substantial financial impact on Ocuphire Pharma, with potential for non-dilutive funding and continuous income.
• Market Strategy: The cash-pay utilization strategy for RYZUMVI faces potential challenges, including price competition and market resistance.
• Regulatory Compliance: Compliance with regulatory requirements is crucial for the drug's success, with Viatris's expertise being a key factor.

FAQs

What is RYZUMVI used for?

RYZUMVI is used to treat pharmacologically-induced mydriasis, or dilation of the pupils, which can occur during comprehensive eye exams.

Who are the key partners involved in the commercialization of RYZUMVI?

Ocuphire Pharma and Viatris Inc. are the key partners involved in the development and commercialization of RYZUMVI.

What are the potential financial benefits for Ocuphire Pharma from the commercialization of RYZUMVI?

The commercialization of RYZUMVI could provide non-dilutive funding through milestones and a continuous income source through royalties, improving Ocuphire Pharma's financial health.

What are the main challenges facing the commercialization of RYZUMVI?

The main challenges include the competitive landscape, potential price competition, market resistance, and the need for effective marketing strategies.

What is Viatris's goal for its eye care portfolio, including RYZUMVI?

Viatris aims to reach $1 billion in eye care sales by 2028, with RYZUMVI being a key product in achieving this goal.

Cited Sources:

1. Ocuphire Announces the U.S. Commercial Launch of RYZUMVI - Stock Titan
2. Ocuphire Pharma Announces Financial Results for First Quarter 2024 - Stock Titan
3. Earnings call: Viatris reports strong 2023 results, eyes growth in 2024 - Investing.com
4. Viatris and Ocuphire score dilation eye drop nod in quest to become global eye care leader - Fierce Pharma
5. Ocuphire Pharma Gambles on Cash-Pay Strategy for RYZUMVI - TipRanks