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YUPELRI Drug Patent Profile

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

Yupelri is a drug marketed by Mylan Ireland Ltd and is included in one NDA. There are twenty patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Yupelri

Yupelri was eligible for patent challenges on November 9, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 25, 2031. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for YUPELRI

International Patents:	73
US Patents:	20
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	2
Patent Applications:	110
Drug Prices:	Drug price information for YUPELRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YUPELRI
What excipients (inactive ingredients) are in YUPELRI?	YUPELRI excipients list
DailyMed Link:	YUPELRI at DailyMed

See drug prices for YUPELRI

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

Constraining patent/regulatory exclusivity:

8,541,451

NDA:

210598

Dosage:

SOLUTION;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.

Recent Clinical Trials for YUPELRI

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

Sponsor	Phase
Mylan Inc.	Phase 4
Theravance Biopharma	Phase 4
Mylan Inc.	Phase 1

See all YUPELRI clinical trials

Pharmacology for YUPELRI

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Paragraph IV (Patent) Challenges for YUPELRI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YUPELRI	Inhalation Solution	revefenacin	175 mcg/3 mL	210598	7	2022-11-09

US Patents and Regulatory Information for YUPELRI

YUPELRI is protected by twenty US patents.

This potential generic entry date is based on patent 8,541,451.

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
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	7,491,736
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	8,034,946		Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes	8,053,448

International Patents for YUPELRI

When does loss-of-exclusivity occur for YUPELRI?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

Poland

Portugal

San Marino

Singapore

Slovenia

South Korea

Spain

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 YUPELRI around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2557553
Malaysia	144482	BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS
San Marino	T201600019	FORMA DI BASE LIBERA CRISTALLINA DI UN COMPOSTO BIFENILICO

YUPELRI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for YUPELRI

Introduction

YUPELRI (revefenacin) is a groundbreaking respiratory medication developed by Theravance Biopharma, Inc. and commercialized in partnership with Viatris Inc. It is the first and only once-daily, nebulized long-acting muscarinic agent (LAMA) bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of YUPELRI.

Market Position and Growth

YUPELRI has demonstrated steady market share and volume growth despite the challenges posed by the COVID-19 pandemic. The drug has shown resilience in a market that saw significant declines in hospital purchasing and new treatment starts during the pandemic[4].

Hospital and Community Sales

YUPELRI's hospital volumes have seen significant growth, with a 46% increase in hospital volumes in Q4 2023 compared to Q4 2022, exceeding internal targets. This growth has been driven by both hospital-based and community-based sales forces[1].

Market Share

The drug has continued to capture more of the addressable market, with steady market share growth across both hospital and retail channels. This is evident from the consistent increase in weekly hospital doses and retail prescriptions (TRx)[4].

Financial Performance

The financial performance of YUPELRI is closely tied to its sales and the partnership with Viatris.

Quarterly and Annual Sales

In Q4 2023, YUPELRI net sales recognized by Viatris reached an all-time high of $60.6 million, representing a 9% increase from Q4 2022 and a 4% increase from Q3 2023. For Q1 2024, net sales were $55.2 million, up 18% from Q1 2023[1][2].

Revenue and Collaboration

Theravance Biopharma's revenue from YUPELRI is derived from its 35% share of net sales and its proportionate share of the total shared costs incurred with Viatris. In Q4 2023, the Viatris collaboration revenue increased by $2.7 million, or 19%, compared to the same period in 2022. For Q1 2024, this revenue increased by $4.1 million, or 39%, compared to Q1 2023[1][2].

Profitability

Theravance Biopharma achieved profitability on a Non-GAAP basis in Q4 2023, with a Non-GAAP Net Profit of $1.4 million, driven by YUPELRI growth and effective expense management. This marks a significant milestone in the company's financial trajectory[1].

Clinical and Regulatory Developments

FDA Approvals and Designations

YUPELRI has received key regulatory approvals and designations. It was launched in 2019 and has since been granted Orphan Drug Designation from the FDA for another product, ampreloxetine, which is in Phase 3 trials[1].

Clinical Studies

Theravance Biopharma initiated the ampreloxetine Phase 3 CYPRESS study in the first quarter of 2023 and is on track to enroll the last patient in the open-label portion of the study by the second half of 2024. Additionally, the PIFR-2 clinical study, in partnership with Viatris, aims to capture more of the addressable market and strengthen YUPELRI's competitive advantage[1][4].

Competitive Landscape

YUPELRI operates in a competitive respiratory market, but its unique once-daily, nebulized formulation sets it apart.

Market Challenges

Despite the overall decline in hospital purchasing and new treatment starts due to the COVID-19 pandemic, YUPELRI has maintained its market share and volume growth. Pulmonologists, who are key prescribers, have been enlisted for various COVID-19 related duties, but YUPELRI's sales have continued to increase[4].

Future Growth Potential

YUPELRI remains early in its product lifecycle and has significant potential for future growth. Consensus estimates suggest US peak-year sales could reach around $400 million[4].

Financial Projections and Outlook

Revenue Projections

The steady growth in YUPELRI sales and the expansion of its market share indicate a positive revenue outlook. With continued growth, Theravance Biopharma expects to see increased cash flows from YUPELRI, contributing significantly to shareholder value[4].

Expense Management

Effective expense management has been a key factor in Theravance Biopharma's ability to achieve profitability. The company has implemented significant cost-saving measures, including a reduction in headcount and annualized operating expense savings of around $170 million in 2022[4].

Key Takeaways

• Steady Market Growth: YUPELRI has shown consistent market share and volume growth despite pandemic-related challenges.
• Financial Performance: The drug has driven significant revenue growth, with Theravance Biopharma achieving Non-GAAP profitability in Q4 2023.
• Regulatory and Clinical Developments: Key regulatory approvals and ongoing clinical studies, such as the CYPRESS study, are expected to further strengthen YUPELRI's market position.
• Competitive Advantage: YUPELRI's unique formulation and growing market share set it apart in the competitive respiratory market.
• Future Growth Potential: With consensus estimates suggesting US peak-year sales of around $400 million, YUPELRI has significant room for future growth.

FAQs

What is YUPELRI and how is it used?

YUPELRI (revefenacin) is a once-daily, nebulized long-acting muscarinic agent (LAMA) bronchodilator approved for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Who commercializes YUPELRI?

YUPELRI is commercialized in partnership with Viatris Inc.

How has YUPELRI performed financially in recent quarters?

In Q4 2023, YUPELRI net sales reached $60.6 million, a 9% increase from Q4 2022. For Q1 2024, net sales were $55.2 million, up 18% from Q1 2023.

What are the key regulatory developments for YUPELRI?

YUPELRI has been granted Orphan Drug Designation from the FDA for another product, ampreloxetine, which is in Phase 3 trials.

What is the future growth potential for YUPELRI?

Consensus estimates suggest US peak-year sales for YUPELRI could reach around $400 million, indicating significant room for future growth.

Sources

1. Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results - Investor Theravance Biopharma.
2. Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results - Investor Theravance Biopharma.
3. Theravance study shows YUPELRI improves COPD lung function - Investing.com.
4. TBPH Investor Presentation January 2022 - Theravance Biopharma.
5. Theravance Biopharma, Inc. Announces Strategic Actions and Reports Fourth Quarter and Full Year 2022 Financial Results and Business Update - BioSpace.