Revefenacin - Generic Drug Details

What are the generic sources for revefenacin and what is the scope of freedom to operate?

Revefenacin is the generic ingredient in one branded drug marketed by Mylan Ireland Ltd and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for revefenacin

International Patents:	73
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	18
Patent Applications:	194
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for revefenacin
What excipients (inactive ingredients) are in revefenacin?	revefenacin excipients list
DailyMed Link:	revefenacin at DailyMed

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

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 revefenacin

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

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

See all revefenacin clinical trials

Pharmacology for revefenacin

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for revefenacin

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for REVEFENACIN

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 revefenacin

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				Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes				Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes

International Patents for revefenacin

Country	Patent Number	Title	Estimated Expiration
Singapore	10201407913U	CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND
Germany	602005006757
European Patent Office	2453894	FORME CRISTALLINE D'UNE BASE LIBRE D'UNE COMPOSE DE BIPHENYLE (CRYSTALLINE FREEBASE FORM OF A BIPHENYL COMPOUND)
Australia	2010273514	Crystalline freebase forms of a biphenyl compound
Cyprus	1117075
Hungary	E026414

Revefenacin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Revefenacin (YUPELRI)

Introduction

Revefenacin, marketed as YUPELRI, is a 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 this drug, highlighting key milestones, sales performance, and future outlook.

Market Position and Growth

Market Share

YUPELRI has consistently demonstrated strong market share growth within the long-acting nebulized segment of the COPD market. As of Q4 2023, YUPELRI held a 31.0% market share in community settings and a 16.6% share in hospital settings, up from 27.1% and 12.5%, respectively, in Q4 2022[1].

Sales Performance

The sales of YUPELRI have shown significant growth over the past few years. In Q4 2023, net sales reached an all-time high of $60.6 million, a 9% increase from Q4 2022 and a 4% increase from Q3 2023[1]. For Q1 2024, net sales were $55.2 million, representing an 18% year-over-year increase from Q1 2023[3][5].

Hospital Channel Growth

The hospital channel has been a key driver of YUPELRI's sales growth. In Q4 2023, doses sold into the hospital channel increased by 37% year-over-year, and in Q1 2024, this growth continued with a 31% year-over-year increase[1][3].

Customer Demand and Market Expansion

Customer demand for YUPELRI has been robust. Despite a slight decrease in net sales in Q2 2024 due to channel mix and pricing factors, customer demand increased by 13% compared to Q2 2023[4]. This demand, coupled with effective commercial execution, has helped YUPELRI expand its market presence.

Financial Performance

Revenue and Profitability

In Q4 2023, Theravance Biopharma achieved a Non-GAAP net profit of $1.4 million, marking a significant milestone in profitability. This was driven by YUPELRI's growth and effective expense management[1].

Collaboration Revenue

The collaboration with Viatris has been lucrative. In Q1 2024, Viatris collaboration revenue increased by 39% year-over-year to $14.5 million, reflecting margin improvements[5].

Capital Return Program

Theravance Biopharma completed a $325 million capital return program in early 2024, reducing shares outstanding by 37%. This move has enhanced shareholder value and reflects the company's strong financial position[1].

Future Outlook and Milestones

Ampreloxetine and Other Pipeline Developments

While YUPELRI is the current flagship product, Theravance Biopharma is also advancing other pipeline assets, such as ampreloxetine. Ampreloxetine, an investigational norepinephrine reuptake inhibitor, is in Phase 3 trials for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). The company expects to enroll the last patient in the open-label portion of the CYPRESS study by mid-2025, with top-line data anticipated approximately six months later[4].

TRELEGY Milestones

Theravance Biopharma is also eligible for milestone payments from Royalty Pharma based on the sales performance of TRELEGY, another product in its portfolio. If TRELEGY achieves certain sales thresholds, Theravance Biopharma could receive up to $200 million in milestone payments, with the next milestone payment of $25 million achievable if TRELEGY global net sales reach approximately $2.9 billion in 2024[1][4].

Regulatory and Patent Developments

Additional Method of Use Patent

In July 2024, YUPELRI was granted an additional method of use patent, further strengthening its intellectual property position[4].

NDA Submission in China

Viatris submitted a New Drug Application (NDA) for YUPELRI in China, with a potential milestone payment of $7.5 million if approved[4].

Challenges and Headwinds

Near-Term Headwinds

In Q2 2024, YUPELRI net sales decreased by 1% due to near-term headwinds from an evolved channel mix and a lower realized net price. However, the company remains confident in the product's long-term growth potential[4].

Key Takeaways

• Strong Sales Growth: YUPELRI has consistently shown strong sales growth, driven by increasing customer demand and hospital channel expansion.
• Market Share Expansion: The drug has increased its market share within the long-acting nebulized segment of the COPD market.
• Financial Performance: Theravance Biopharma achieved Non-GAAP profitability in Q4 2023 and has a robust financial position.
• Pipeline Advancements: The company is making progress with ampreloxetine and other pipeline assets.
• Regulatory Milestones: Additional patents and NDA submissions in new markets are expected to further enhance YUPELRI's market position.

FAQs

1. What is YUPELRI used for? YUPELRI is used for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

2. How has YUPELRI's sales performance been in recent quarters? YUPELRI's sales have shown significant growth, with Q4 2023 sales reaching an all-time high of $60.6 million and Q1 2024 sales increasing by 18% year-over-year.

3. What are the key drivers of YUPELRI's sales growth? The key drivers include increasing customer demand and significant growth in the hospital channel.

4. What is the current status of ampreloxetine? Ampreloxetine is in Phase 3 trials for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA), with enrollment expected to complete by mid-2025.

5. What are the potential milestone payments related to TRELEGY? Theravance Biopharma is eligible for up to $200 million in milestone payments from Royalty Pharma based on TRELEGY's sales performance, with the next milestone payment achievable if TRELEGY global net sales reach approximately $2.9 billion in 2024.

Sources

1. Theravance Biopharma, Inc. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update - Investor Relations, Theravance Biopharma.
2. Theravance Biopharma, Inc. Highlights 2022 Accomplishments and 2023 Key Targets - PR Newswire.
3. Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update - PR Newswire.
4. Theravance Biopharma, Inc. Reports Second Quarter 2024 Financial Results and Provides Business Update - PR Newswire.
5. Theravance Biopharma, Inc. Reports First Quarter 2024 Financial Results and Provides Business Update - Theravance Biopharma.