TYRVAYA Drug Patent Profile

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

Tyrvaya is a drug marketed by Oyster Point Pharma and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-eight patent family members in nineteen countries.

The generic ingredient in TYRVAYA is varenicline tartrate. There are twelve drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the varenicline tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tyrvaya

A generic version of TYRVAYA was approved as varenicline tartrate by ENDO OPERATIONS on August 11^th, 2021.

Summary for TYRVAYA

International Patents:	38
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	1
Patent Applications:	132
Drug Prices:	Drug price information for TYRVAYA
What excipients (inactive ingredients) are in TYRVAYA?	TYRVAYA excipients list
DailyMed Link:	TYRVAYA at DailyMed

See drug prices for TYRVAYA

Recent Clinical Trials for TYRVAYA

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

Sponsor	Phase
Duke University	Phase 4

See all TYRVAYA clinical trials

Pharmacology for TYRVAYA

Drug Class	Cholinergic Receptor Agonist Partial Cholinergic Nicotinic Agonist
Mechanism of Action	Cholinergic Agonists Partial Cholinergic Nicotinic Agonists

Paragraph IV (Patent) Challenges for TYRVAYA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TYRVAYA	Nasal Spray	varenicline tartrate	0.03 mg/spray	213978	1	2023-04-21

US Patents and Regulatory Information for TYRVAYA

TYRVAYA is protected by ten 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
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	11,224,598
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	11,903,943
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	9,532,944
Oyster Point Pharma	TYRVAYA	varenicline tartrate	SPRAY;NASAL	213978-001	Oct 15, 2021		RX	Yes	Yes	11,903,941

International Patents for TYRVAYA

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

Country	Patent Number	Title	Estimated Expiration
Denmark	3209295
China	111956803	治疗眼部病状的方法 (Methods of treating ocular conditions)
Mexico	2017005064	METODOS PARA TRATAR AFECCIONES OCULARES. (METHODS OF TREATING OCULAR CONDITIONS.)
European Patent Office	4413974	MÉTHODES DE TRAITEMENT DE TROUBLES OCULAIRES (METHODS OF TREATING OCULAR CONDITIONS)

Supplementary Protection Certificates for TYRVAYA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1044189	08C0039	France		PRODUCT NAME: VARENICLINE OU L?UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, NOTAMMENT LE TARTRATE; REGISTRATION NO/DATE IN FRANCE: EU/1/06/360/001 DU 20060926; REGISTRATION NO/DATE AT EEC: EU/1/06/360/001 DU 20060926
1044189	SPC/GB08/034	United Kingdom		PRODUCT NAME: VARENICLINE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING THE TARTRATE SALT; REGISTRATION NO/DATE: EU/1/06/360/001 - 010 20060928

TYRVAYA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for TYRVAYA

Introduction to TYRVAYA

TYRVAYA, developed by Oyster Point Pharma, is the first FDA-approved nasal spray for the treatment of dry eye disease (DED). This innovative treatment marks a significant shift in the management of DED, a condition affecting approximately 38 million Americans, characterized by symptoms such as stinging, sensitivity to light, blurred vision, and eye fatigue[1].

Market Size and Potential

The market for dry eye syndrome treatments is substantial and growing. The global dry eye syndrome treatment market is estimated to reach $9.20 billion by 2030, expanding at a CAGR of 6.5% from 2025 to 2030. This growth is driven by the increasing prevalence of the disease and the need for more effective and convenient treatment options[4].

TYRVAYA, in particular, has a significant market potential. According to Cowen and Co analyst Ken Cacciatore, TYRVAYA's potential market size could exceed $1 billion, given the large and underserved market for DED treatments[1].

Competitive Landscape

The dry eye syndrome treatment market is dominated by over-the-counter (OTC) products, with only 10% of the diagnosed population using prescription therapies. Existing prescription products like Xiidra and Restasis have limitations, such as slow onset of action and tolerability issues, which creates an opportunity for new and innovative treatments like TYRVAYA[4].

TYRVAYA stands out as a nasal spray, offering a unique delivery method that could improve patient compliance and efficacy compared to traditional eye drops. This differentiation could help TYRVAYA capture a significant share of the prescription market segment.

Financial Performance

Since its FDA approval and commercial launch in November 2021, TYRVAYA has shown promising financial results. Here are some key financial highlights:

• Initial Revenue: In the fourth quarter of 2021, Oyster Point Pharma reported $1.2 million in net product revenue from TYRVAYA sales. This was supplemented by $5.4 million in milestone and license revenue related to the Ji Xing License Agreement[5].
• Cash Position: As of December 31, 2021, the company had $193.4 million in cash, cash equivalents, and restricted cash, which was boosted by financing operations, including borrowing under the OrbiMed Credit Agreement[5].
• Operational Costs: The company incurred significant operating expenses, including sales and marketing, general and administrative, and research and development costs, totaling $44 million in the fourth quarter of 2021[5].

Growth Prospects

TYRVAYA's growth prospects are tied to several factors:

• Market Penetration: As more patients and healthcare providers become aware of TYRVAYA, its market share is expected to increase. The convenience and efficacy of the nasal spray delivery method could drive adoption rates.
• Insurance Coverage: While patients may initially face out-of-pocket costs of around $10 for a two-week dose if insurers do not cover the drug, securing broader insurance coverage could significantly boost sales[1].
• Competitive Advantage: TYRVAYA's unique delivery mechanism and potential for better patient outcomes could help it differentiate from existing treatments, attracting more patients and prescribers.

Strategic Initiatives

Oyster Point Pharma and its partners are likely to focus on several strategic initiatives to drive TYRVAYA's growth:

• Marketing and Education: Increasing awareness among patients and healthcare providers about the benefits of TYRVAYA.
• Clinical Trials and Research: Continuing to gather data on the efficacy and safety of TYRVAYA to support its market position and potential expansion into other indications.
• Partnerships and Collaborations: Forming alliances with other pharmaceutical companies, distributors, and healthcare organizations to enhance market reach and penetration.

Financial Trajectory

Given the market potential and the initial financial performance, here is a possible financial trajectory for TYRVAYA:

• Short-Term: Continued growth in net product revenue as the drug gains more market acceptance and insurance coverage. Oyster Point Pharma may also see increased milestone and license revenues from partnerships.
• Medium-Term: Expansion of the product's market share, driven by increased awareness and adoption. This could lead to significant revenue growth, potentially exceeding the $1 billion market size estimate.
• Long-Term: TYRVAYA could become a cornerstone product for Oyster Point Pharma, driving sustained revenue growth and profitability. The company may also explore additional indications for the drug, further expanding its market potential.

Key Takeaways

• Market Potential: TYRVAYA has a significant market potential, estimated to exceed $1 billion.
• Unique Delivery Method: The nasal spray delivery method offers a competitive advantage over traditional eye drops.
• Financial Performance: Initial revenue and cash position indicate a promising start, with room for significant growth.
• Strategic Initiatives: Marketing, education, clinical trials, and partnerships are crucial for driving growth.
• Growth Prospects: Market penetration, insurance coverage, and competitive advantage are key factors for future growth.

FAQs

What is TYRVAYA and how does it treat dry eye disease?

TYRVAYA is the first FDA-approved nasal spray for the treatment of dry eye disease. It works by stimulating the trigeminal nerve to increase tear production, providing relief from symptoms such as stinging, sensitivity to light, and blurred vision.

How large is the market for dry eye syndrome treatments?

The global dry eye syndrome treatment market is estimated to reach $9.20 billion by 2030, growing at a CAGR of 6.5% from 2025 to 2030.

What is the potential market size for TYRVAYA?

According to Cowen and Co analyst Ken Cacciatore, TYRVAYA's potential market size could exceed $1 billion.

How does TYRVAYA differentiate itself from other dry eye treatments?

TYRVAYA differentiates itself through its unique nasal spray delivery method, which could improve patient compliance and efficacy compared to traditional eye drops.

What are the key factors driving the growth of TYRVAYA?

Key factors include market penetration, securing broader insurance coverage, and the competitive advantage offered by its unique delivery method.

Sources

1. Reuters: FDA approves Oyster Point's nasal spray for dry eye disease[1].
2. Viatris Investor Relations: Viatris Reports Strong Financial and Operational Results for the Third Quarter 2023[2].
3. Viatris Investor Relations: 2023 Annual Report[3].
4. Grand View Research: Global Dry Eye Syndrome Treatment Market Report[4].
5. GlobeNewswire: Oyster Point Pharma Reports Fourth Quarter and Full Year 2021 Financial Results and Recent Business Highlights[5].