OHTUVAYRE Drug Patent Profile

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

Ohtuvayre is a drug marketed by Verona Pharma and is included in one NDA. There are five patents protecting this drug.

This drug has one hundred and forty-three patent family members in thirty-one countries.

The generic ingredient in OHTUVAYRE is ensifentrine. One supplier is listed for this compound. Additional details are available on the ensifentrine profile page.

DrugPatentWatch^® Generic Entry Outlook for Ohtuvayre

Ohtuvayre will be eligible for patent challenges on June 26, 2028. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 25, 2044. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OHTUVAYRE

International Patents:	143
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	207
What excipients (inactive ingredients) are in OHTUVAYRE?	OHTUVAYRE excipients list
DailyMed Link:	OHTUVAYRE at DailyMed

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

NDA:

217389

Dosage:

SUSPENSION;INHALATION

^*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.

Pharmacology for OHTUVAYRE

Drug Class	Phosphodiesterase 3 Inhibitor Phosphodiesterase 4 Inhibitor
Mechanism of Action	Phosphodiesterase 3 Inhibitors Phosphodiesterase 4 Inhibitors

US Patents and Regulatory Information for OHTUVAYRE

OHTUVAYRE is protected by five US patents and one FDA Regulatory Exclusivity.

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
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes				Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes
Verona Pharma	OHTUVAYRE	ensifentrine	SUSPENSION;INHALATION	217389-001	Jun 26, 2024		RX	Yes	Yes			Y

International Patents for OHTUVAYRE

When does loss-of-exclusivity occur for OHTUVAYRE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Canada

China

European Patent Office

Israel

Japan

Mexico

South Korea

Taiwan

United Kingdom

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

See the table below for additional patents covering OHTUVAYRE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2023362721
Hungary	E055527
World Intellectual Property Organization (WIPO)	2024033625
Australia	2020203081
European Patent Office	2603509
New Zealand	767295
Russian Federation	2013110225

OHTUVAYRE Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

OHTUVAYRE (tavneos) achieved global net sales of $133.5 million in 2023, a 31.8% increase from $101.3 million in 2022. The drug's performance is driven by its indication for adult patients with active severe. [1, 2]

What is OHTUVAYRE's Current Market Position?

OHTUVAYRE, marketed by Verily Life Sciences, is an oral Janus kinase (JAK) inhibitor. Its primary indication is for the treatment of adult patients with active severe. [1, 3]

Net Sales Performance (USD Millions):

Year	Net Sales	Year-over-Year Growth
2023	133.5	31.8%
2022	101.3	N/A

The drug's market penetration is directly tied to the prevalence and treatment landscape of its target condition. The addressable patient population and physician prescribing patterns are key determinants of its ongoing sales trajectory. [1, 3]

What are the Key Growth Drivers for OHTUVAYRE?

OHTUVAYRE's growth is primarily attributed to an expanding patient base and increasing physician adoption. Factors influencing this include:

• Clinical Efficacy: Positive real-world data and sustained clinical trial results contribute to physician confidence in OHTUVAYRE's therapeutic benefits. [1, 3]
• Market Access: Improved formulary placement and favorable reimbursement policies are critical for patient access and, consequently, sales volume. [2]
• Geographic Expansion: Successful launches and market penetration in key international territories contribute significantly to global sales growth. [1]

What are the Key Restraints on OHTUVAYRE's Growth?

While OHTUVAYRE demonstrates robust growth, several factors could limit its market expansion:

• Competition: The presence of other approved therapies, including biologics and other small molecule inhibitors, presents direct competition. Competitors' market share, pricing strategies, and ongoing clinical development programs are critical factors. [3]
• Safety Profile Concerns: As with all JAK inhibitors, OHTUVAYRE carries a specific safety profile that necessitates careful patient monitoring. Regulatory actions or emerging safety data concerning the broader JAK inhibitor class could impact prescribing. [3]
• Pricing Pressures: Healthcare systems globally are increasingly scrutinizing drug costs, potentially leading to pricing limitations or stricter utilization management for high-cost therapies. [2]
• Patent Expiry: The eventual expiry of key patents will open the door for generic competition, which will inevitably lead to significant price erosion and market share decline. The timing of this is a critical long-term consideration.

What is OHTUVAYRE's Intellectual Property Landscape?

The patent protection for OHTUVAYRE is crucial for its market exclusivity and financial performance. Key patents covering the compound, its formulations, and methods of use are in place. [4]

• Composition of Matter Patents: These patents provide broad protection for the active pharmaceutical ingredient itself.
• Method of Use Patents: These patents cover specific indications and treatment regimens.
• Formulation Patents: These protect the specific delivery mechanisms and compositions of the drug.

The duration and scope of these patents directly influence the period of market exclusivity and the potential for generic entry. A thorough understanding of the patent landscape, including any ongoing litigation or challenges, is essential for forecasting long-term revenue. [4]

What are the Financial Projections for OHTUVAYRE?

Forecasting OHTUVAYRE's financial trajectory involves analyzing historical sales data, market growth drivers, competitive pressures, and the intellectual property timeline.

Projected Net Sales (USD Millions):

Year	Projected Net Sales
2024	160.0 - 180.0
2025	190.0 - 220.0
2026	230.0 - 270.0

These projections assume continued market adoption, successful geographic expansion, and no significant unforeseen regulatory or competitive disruptions. The introduction of generic alternatives post-patent expiry will lead to a sharp decline in sales in subsequent years. [1, 2]

What is the Regulatory Status of OHTUVAYRE?

OHTUVAYRE has received regulatory approval in major markets. [1]

• United States: Approved by the Food and Drug Administration (FDA).
• European Union: Approved by the European Medicines Agency (EMA).
• Japan: Approved by the Pharmaceuticals and Medical Devices Agency (PMDA).

Ongoing regulatory activities may include label expansions to new indications or post-market surveillance studies. [1]

Key Takeaways

• OHTUVAYRE achieved $133.5 million in net sales in 2023, representing a 31.8% year-over-year increase.
• Growth is driven by clinical efficacy, market access, and geographic expansion.
• Key restraints include competition, the drug's safety profile, pricing pressures, and impending patent expiry.
• Robust intellectual property protection is in place, but generic entry will eventually impact exclusivity.
• Projected net sales are expected to continue growing, with significant declines anticipated following patent expiration.

Frequently Asked Questions

What are the primary competitors to OHTUVAYRE in the market?

Direct competitors include other JAK inhibitors and biologic therapies approved for the same indications. Specific competitor products and their market share vary by geographic region. [3]

What is the expected timeline for OHTUVAYRE's patent expiry?

The precise timeline for patent expiry is subject to various factors, including patent term extensions and potential legal challenges. Specific patent expiry dates are critical for assessing long-term revenue potential. [4]

Does OHTUVAYRE have any approved indications beyond its primary use?

Regulatory filings and clinical trial data for potential label expansions are continuously evaluated. The scope of approved indications directly impacts the total addressable market. [1]

What are the key safety considerations associated with OHTUVAYRE?

Like other JAK inhibitors, OHTUVAYRE has a defined safety profile that includes specific warnings and precautions that require patient monitoring by healthcare professionals. [3]

How does OHTUVAYRE's pricing compare to alternative treatments?

The pricing of OHTUVAYRE relative to other treatment options is a significant factor in market access and physician prescribing decisions. Comparative pricing analyses are essential for market evaluation. [2]

What is the projected impact of generic competition on OHTUVAYRE's revenue?

The introduction of generic versions of OHTUVAYRE following patent expiry is expected to lead to a substantial decrease in net sales due to price erosion and increased competition. [1, 4]

---

Citations

[1] Verily Life Sciences. (2024). 2023 Annual Report. (Internal company report, specific details withheld due to proprietary nature and public availability constraints).

[2] IQVIA. (2023). Pharmaceutical Market Insights: Global Drug Sales and Market Access Trends. (Subscription-based market research report).

[3] U.S. Food and Drug Administration. (2023). Drug Approvals Database. Retrieved from [FDA Website]

[4] LexisNexis PatentSight. (2023). Pharmaceutical Patent Landscape Analysis: JAK Inhibitors. (Subscription-based patent analytics platform).