VOQUEZNA Drug Patent Profile

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

Voquezna is a drug marketed by Phathom and is included in three NDAs. 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 is amoxicillin; clarithromycin; 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; clarithromycin; vonoprazan fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Voquezna

Voquezna 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 August 11, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VOQUEZNA

International Patents:	103
US Patents:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Patent Applications:	51
Drug Prices:	Drug price information for VOQUEZNA
What excipients (inactive ingredients) are in VOQUEZNA?	VOQUEZNA excipients list
DailyMed Link:	VOQUEZNA at DailyMed

See drug prices for VOQUEZNA

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

NDA:

215151

Dosage:

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

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

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	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No				Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes				Y
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No
Phathom	VOQUEZNA DUAL PAK	amoxicillin; vonoprazan fumarate	CAPSULE, TABLET;ORAL	215153-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes
Phathom	VOQUEZNA TRIPLE PAK	amoxicillin; clarithromycin; vonoprazan fumarate	CAPSULE, TABLET, TABLET;ORAL	215152-001	May 3, 2022		RX	Yes	Yes				Y

International Patents for VOQUEZNA

When does loss-of-exclusivity occur for VOQUEZNA?

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 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	E504567
Brazil	122017028096	composto, composição farmacêutica, e, uso do composto
New Zealand	566378	1-Heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors
Cyprus	1111922
China	104784180	Pharmaceutical composition
Norway	20081464
Hong Kong	1118547	1-HETEROCYCLYLSULFONYL, 2-AMINOMETHYL, 5- (HETERO-) ARYL SUBSTITUTED 1-H- PYRROLE DERIVATIVES AS ACID SECRETION INHIBITORS

Market Dynamics and Financial Trajectory for VOQUEZNA

Introduction to VOQUEZNA

VOQUEZNA, developed by Phathom Pharmaceuticals, is a groundbreaking treatment for gastroesophageal reflux disease (GERD), specifically targeting both Erosive and Non-Erosive forms of the condition. This drug represents the first new class of treatment for Erosive GERD approved in the U.S. in over three decades.

Market Need and Demand

The market for GERD treatments is substantial, with over 22 million diagnosed and annually treated patients in the U.S. alone. The recent FDA approval for Non-Erosive GERD has significantly expanded VOQUEZNA's market opportunity, highlighting a high unmet need in GERD treatment[1][3][4].

Launch Progress and Prescription Growth

Since its launch in November 2023, VOQUEZNA has shown robust growth in prescriptions. Here are some key milestones:

• Prescription Demand: As of October 25, 2024, over 143,000 prescriptions for VOQUEZNA products have been filled, representing a 138% increase from the previous quarter's 60,000 filled prescriptions[1].
• Sequential Growth: The third quarter of 2024 saw a near doubling of filled prescriptions, with over 69,000 prescriptions filled compared to approximately 35,000 in the second quarter[1].
• Prescriber Base: The number of prescribers has grown significantly, with over 13,600 cumulative prescribers as of October 18, 2024, a 65% increase from the previous quarter[1].

Commercial Coverage and Access

Phathom Pharmaceuticals has secured broad and favorable commercial coverage for VOQUEZNA, with access now expanded to over an estimated 120 million U.S. commercially covered lives, representing over 80% of U.S. commercial lives. This extensive coverage has been a crucial factor in the drug's market adoption[1][3].

Financial Performance

Revenue

• Second Quarter 2024: Net revenues were $7.3 million, a significant increase from $1.9 million in the first quarter 2024, and no revenues in the second quarter 2023 due to the launch timing[2][3].
• Third Quarter 2024: While specific revenue figures for the third quarter are not provided, the substantial increase in prescriptions suggests continued revenue growth[1].

Research and Development (R&D) Expenses

• Decrease in R&D Expenses: R&D expenses have decreased due to the wrap-up of activities related to the Phase 3 PHALCON-NERD-301 daily dosing study and lower chemistry manufacturing and controls activity. For the second quarter 2024, R&D expenses were $7.4 million, down from $12.8 million in the second quarter 2023[2][3].

Selling, General, and Administrative (SG&A) Expenses

• Increase in SG&A Expenses: SG&A expenses have increased significantly due to higher personnel costs and increased activity related to the buildout of commercial infrastructure and marketing. For the second quarter 2024, SG&A expenses were $75.9 million, up from $18.9 million in the second quarter 2023[2][3].

Net Loss

• Net Loss: Despite revenue growth, Phathom Pharmaceuticals reported a net loss of $91.4 million for the second quarter 2024, compared to $41.0 million in the second quarter 2023. The non-GAAP adjusted net loss for the second quarter 2024 was $73.3 million[2].

Funding and Financial Position

Phathom Pharmaceuticals has strengthened its financial position through various means:

• Equity Raise: A successful $130 million equity raise in the third quarter 2024 further enhances the company's ability to invest in the growth of the VOQUEZNA brand[1].
• Expanded Term Loan Facility: The company has access to an additional $160 million under an expanded term loan facility, extending its cash runway through 2026[4].

Regulatory and Market Sentiment

The FDA approval for Non-Erosive GERD in July 2024 has been a significant regulatory milestone, expanding VOQUEZNA's market opportunity. The positive feedback from healthcare providers and patients, along with favorable payer coverage, reinforces the drug's potential to displace standard proton pump inhibitors (PPIs)[1][3].

Key Takeaways

• Robust Prescription Growth: VOQUEZNA has seen significant growth in prescriptions, with over 143,000 prescriptions filled as of October 25, 2024.
• Expanding Prescriber Base: The number of prescribers has grown to over 13,600, indicating strong market adoption.
• Broad Commercial Coverage: Access to over 120 million U.S. commercially covered lives has been a key factor in the drug's success.
• Financial Performance: While revenue is growing, the company is currently operating at a net loss due to high SG&A expenses.
• Strong Financial Position: Phathom Pharmaceuticals has secured additional funding through equity raises and an expanded term loan facility.

FAQs

What is VOQUEZNA and what does it treat?

VOQUEZNA is a treatment for gastroesophageal reflux disease (GERD), specifically targeting both Erosive and Non-Erosive forms of the condition.

When was VOQUEZNA launched?

VOQUEZNA was launched in November 2023.

How many prescriptions have been filled for VOQUEZNA as of the third quarter 2024?

Over 143,000 prescriptions for VOQUEZNA products have been filled as of October 25, 2024.

What is the current commercial coverage for VOQUEZNA?

VOQUEZNA has access to over an estimated 120 million U.S. commercially covered lives, representing over 80% of U.S. commercial lives.

What are the key financial highlights for Phathom Pharmaceuticals in the second quarter 2024?

Net revenues were $7.3 million, R&D expenses decreased to $7.4 million, SG&A expenses increased to $75.9 million, and the net loss was $91.4 million.

Sources

1. Phathom Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Updates. Biospace, November 7, 2024.
2. Phathom Pharmaceuticals Reports Second Quarter 2024 Financial Results. Phathom Pharmaceuticals, August 8, 2024.
3. Phathom Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update. Biospace, August 8, 2024.
4. Phathom Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update. Phathom Pharmaceuticals, March 7, 2024.
5. Phathom Pharmaceuticals Reports First Quarter 2024 Financial Results and Provides Business Update. GlobeNewswire, May 9, 2024.