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VOQUEZNA DUAL PAK Drug Patent Profile

When do Voquezna Dual Pak patents expire, and when can generic versions of Voquezna Dual Pak launch?

Voquezna Dual Pak is a drug marketed by Phathom and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in VOQUEZNA DUAL PAK is amoxicillin; vonoprazan fumarate. There are forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amoxicillin; vonoprazan fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Voquezna Dual Pak

Voquezna Dual Pak will be eligible for patent challenges on May 3, 2026. 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 May 3, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOQUEZNA DUAL PAK

International Patents:	103
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for VOQUEZNA DUAL PAK
What excipients (inactive ingredients) are in VOQUEZNA DUAL PAK?	VOQUEZNA DUAL PAK excipients list
DailyMed Link:	VOQUEZNA DUAL PAK at DailyMed

See drug prices for VOQUEZNA DUAL PAK

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VOQUEZNA DUAL PAK

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

215153

Dosage:

CAPSULE, TABLET;ORAL

^*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.

US Patents and Regulatory Information for VOQUEZNA DUAL PAK

VOQUEZNA DUAL PAK is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes	9,186,411		Y
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes	7,977,488			Y
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes

International Patents for VOQUEZNA DUAL PAK

When does loss-of-exclusivity occur for VOQUEZNA DUAL PAK?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Singapore

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 VOQUEZNA DUAL PAK around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1111922
Morocco	32556	تركيب صيدلاني
European Patent Office	2564833	Composition pharmaceutique stabilisée à la lumière (Photostabilized pharmaceutical composition)
Brazil	PI0916689	composição farmacêutica estabilizada, preparação sólida, e, métodos para estabilizar uma composição farmacêutica, e para estabilizar uma preparação sólida.
Taiwan	I358296
Japan	5593363

VOQUEZNA DUAL PAK Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VOQUEZNA DUAL PAK

Introduction

VOQUEZNA DUAL PAK, along with VOQUEZNA and VOQUEZNA TRIPLE PAK, is a significant product in Phathom Pharmaceuticals' portfolio, targeting the treatment of various grades of erosive esophagitis and relief of heartburn in adults. Here, we delve into the market dynamics and financial trajectory of VOQUEZNA DUAL PAK, highlighting key trends, financial performance, and future prospects.

Market Indications and Approval

VOQUEZNA, including the DUAL PAK formulation, is indicated for the healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn in adults. A recent label expansion in July 2024 to include Non-Erosive GERD has significantly broadened its market opportunity[1][5].

Commercial Momentum

The commercial launch of VOQUEZNA products has shown robust momentum. As of October 25, 2024, over 143,000 prescriptions for VOQUEZNA tablets, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK have been filled, representing a 138% increase from the previous quarterly report. This growth underscores strong market adoption and positive feedback from both healthcare providers and patients[1][5].

Prescription Growth

The sequential growth of prescriptions filled in the third quarter of 2024 nearly doubled, with over 69,000 prescriptions for VOQUEZNA products filled, compared to approximately 35,000 in the second quarter of 2024. This rapid growth indicates a high demand for the product and a expanding prescriber base, which has grown to more than 13,600 cumulative prescribers as of October 18, 2024[1][5].

Payer Coverage

Phathom Pharmaceuticals has secured broad and favorable commercial coverage for VOQUEZNA, with access now expanded to over an estimated 120 million covered lives, representing over 80% of U.S. commercial lives. This extensive coverage is a critical factor in the product's market success[5].

Competitive Landscape

VOQUEZNA DUAL PAK operates in a competitive landscape but with several differentiators. It has no branded competition, and its novel mechanism of action (MOA) and clinical differentiation set it apart from traditional proton pump inhibitors (PPIs). The goal is to displace PPIs and become the #1 selling acid suppressant, indicating a significant market opportunity[4].

Financial Performance

Revenue

Net revenues for the third quarter of 2024 were $16.4 million, related to sales of VOQUEZNA, VOQUEZNA TRIPLE PAK, and VOQUEZNA DUAL PAK. This is a substantial increase from the first quarter of 2024, where net revenues were $1.9 million. The revenue growth reflects the accelerating commercial momentum of the product[1][2].

Research and Development (R&D) Expenses

R&D expenses for the third quarter of 2024 were $8.7 million, a decrease of $3.6 million compared to the third quarter of 2023. This decrease is attributed to lower clinical trial expenses due to the wrap-up of activities related to the PHALCON-NERD-301 study[1].

Selling, General and Administrative (SG&A) Expenses

SG&A expenses for the third quarter of 2024 were $76.1 million, an increase of $52.7 million compared to the third quarter of 2023. This increase is due to higher personnel costs and increased activity related to the ongoing buildout of commercial infrastructure and marketing activity in support of the launch of VOQUEZNA products[1].

Net Loss

Despite the significant revenue growth, Phathom Pharmaceuticals reported a net loss due to the high SG&A expenses associated with the commercial launch and infrastructure buildout. However, the company remains confident in its financial position, having secured a successful $130 million equity raise to further invest in the growth of the brand[1][5].

Regulatory Environment

The pharmaceutical industry is subject to various regulatory changes, including the Inflation Reduction Act (IRA), which aims to control escalating drug prices. While the IRA has introduced measures to limit annual price hikes, its overall effectiveness is still under observation. For VOQUEZNA, favorable regulatory conditions, such as the recent label expansion, have positively impacted its market dynamics[3].

Patient Care Trends

The increased use of telehealth and patient support programs, such as those offered through BlinkRx, has facilitated better access to VOQUEZNA DUAL PAK. These trends are crucial for optimizing patient outcomes and enhancing the product's market penetration[3].

Future Prospects

Phathom Pharmaceuticals believes that the existing cash, cash equivalents, and anticipated capital will be sufficient to fund operations through the end of 2026. The company has a structured plan for accessing additional capital through specified revenue milestones, ensuring a strong financial foundation for continued growth[4].

Key Takeaways

• Robust Commercial Momentum: VOQUEZNA DUAL PAK has seen significant growth in prescriptions and market adoption.
• Broad Payer Coverage: Extensive commercial coverage has been secured, covering over 80% of U.S. commercial lives.
• Differentiated Profile: The product's novel MOA and clinical differentiation set it apart from traditional PPIs.
• Financial Growth: Revenue has increased substantially, though high SG&A expenses have impacted net results.
• Regulatory Support: Favorable regulatory changes, such as the label expansion for Non-Erosive GERD, have enhanced market opportunities.

FAQs

Q: What is the primary indication for VOQUEZNA DUAL PAK? A: VOQUEZNA DUAL PAK is indicated for the healing and maintenance of healing of all grades of erosive esophagitis and relief of heartburn in adults.

Q: How has the prescription growth for VOQUEZNA products been in 2024? A: The prescriptions for VOQUEZNA products have grown significantly, with over 143,000 prescriptions filled as of October 25, 2024, representing a 138% increase from the previous quarter.

Q: What is the current market coverage for VOQUEZNA? A: VOQUEZNA has secured broad and favorable commercial coverage, with access now expanded to over an estimated 120 million covered lives, representing over 80% of U.S. commercial lives.

Q: How have R&D expenses changed for Phathom Pharmaceuticals in 2024? A: R&D expenses have decreased due to lower clinical trial expenses following the wrap-up of activities related to the PHALCON-NERD-301 study.

Q: What are the future financial prospects for Phathom Pharmaceuticals? A: The company believes its existing cash and anticipated capital will be sufficient to fund operations through the end of 2026, with structured plans for accessing additional capital through specified revenue milestones.

Sources

1. Phathom Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Updates - Phathom Pharmaceuticals.
2. Phathom Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update - Markets Business Insider.
3. Drug Trend Report (Q1-Q2 2024) - intercept.health.
4. CORPORATE OVERVIEW - Phathom Pharmaceuticals.
5. Phathom Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Updates - GlobeNewswire.