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KONVOMEP Drug Patent Profile

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

Konvomep is a drug marketed by Azurity and is included in one NDA. There are six patents protecting this drug.

This drug has five patent family members in five countries.

The generic ingredient in KONVOMEP is omeprazole; sodium bicarbonate. There are one hundred and thirty-one drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the omeprazole; sodium bicarbonate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Konvomep

A generic version of KONVOMEP was approved as omeprazole; sodium bicarbonate by STRIDES PHARMA on April 19^th, 2013.

Summary for KONVOMEP

International Patents:	5
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for KONVOMEP
What excipients (inactive ingredients) are in KONVOMEP?	KONVOMEP excipients list
DailyMed Link:	KONVOMEP at DailyMed

See drug prices for KONVOMEP

US Patents and Regulatory Information for KONVOMEP

KONVOMEP is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes			Y
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes			Y
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes			Y
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes			Y

International Patents for KONVOMEP

See the table below for patents covering KONVOMEP around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2022000623
Canada	3147586
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
European Patent Office	3999066	COMPOSITIONS ET KITS POUR SUSPENSION D'OMÉPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
European Patent Office	3999066
World Intellectual Property Organization (WIPO)	2021011669
Mexico	2022000623	COMPOSICIONES Y KITS PARA UNA SUSPENSION DE OMEPRAZOL. (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION.)

Supplementary Protection Certificates for KONVOMEP

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1411900	SPC/GB11/015	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
0984957	SPC/GB11/013	United Kingdom		PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105

KONVOMEP Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KONVOMEP

Introduction to KONVOMEP

KONVOMEP, a product of Azurity Pharmaceuticals, Inc., is a unique formulation of omeprazole, a proton pump inhibitor (PPI), and sodium bicarbonate, designed as an oral suspension. This FDA-approved medication is specifically indicated for the treatment of active benign gastric ulcers in adults, particularly benefiting those who have difficulty swallowing tablets or capsules[1][4][5].

Market Growth Drivers

The market for KONVOMEP is influenced by several key factors that drive its growth and financial trajectory.

Increasing Prevalence of Gastrointestinal Disorders

The growing prevalence of gastroesophageal reflux disease (GERD) and other gastrointestinal conditions significantly contributes to the demand for proton pump inhibitors like KONVOMEP. For instance, GERD affects approximately 20% of adults in Western societies, and regurgitation or vomiting in infants can be as high as 41% between three and four months of age, highlighting the broad need for effective treatments[4].

Expanding Market Reach

The proton pump inhibitors market, which includes KONVOMEP, is expected to see steady growth due to the adoption of PPIs in emerging markets. This expansion is driven by initiatives focused on patient education and strategic marketing and promotional activities, which help increase awareness and usage of these medications[1].

Innovative Product Approvals

The FDA approval of KONVOMEP in September 2022 marked a significant milestone. As the only FDA-approved omeprazole formulation dispensed as a liquid, it addresses a critical need for patients with swallowing difficulties. Such innovative product approvals are crucial for driving market growth and attracting new patients[1][4].

Digital Health Integration

The integration of PPIs with digital health solutions is another trend expected to impact the market. This integration can enhance patient compliance, monitoring, and overall care, potentially increasing the adoption of medications like KONVOMEP[1].

Financial Trajectory

Market Size and Growth

The proton pump inhibitors market, within which KONVOMEP operates, is projected to grow from $3.3 billion in 2023 to $4.12 billion by 2028, with a compound annual growth rate (CAGR) of 4.6%. This growth is driven by the factors mentioned above, including the increasing prevalence of gastrointestinal disorders and the expansion into emerging markets[1].

Revenue Potential

Given its unique formulation and FDA approval, KONVOMEP is well-positioned to capture a significant share of the growing PPI market. The convenience and lower out-of-pocket costs for eligible patients can further enhance its revenue potential. For commercially insured patients, programs like eVoucherRx™ and Voucher on Demand™ can help reduce prescription costs, making KONVOMEP more accessible and attractive[5].

Competitive Landscape

The market for proton pump inhibitors is competitive, with several established brands. However, KONVOMEP's liquid formulation offers a distinct advantage, particularly for patients with swallowing difficulties. This differentiation can help Azurity Pharmaceuticals to carve out a niche in the market and generate substantial revenue[1][4].

Regulatory and Safety Considerations

FDA Approval and Compliance

The FDA approval of KONVOMEP is a critical factor in its market success. Ensuring ongoing compliance with regulatory measures and safety protocols is essential for maintaining market presence and trust among healthcare providers and patients[1].

Environmental Impact

There is a growing focus on the environmental impact of medications, including PPIs. Companies like Azurity Pharmaceuticals must consider these factors in their product development and distribution strategies to align with evolving regulatory and consumer expectations[1].

Patient Education and Awareness

Heightened Focus on Gastrointestinal Health

Initiatives focused on patient education regarding gastrointestinal health are crucial for increasing the adoption of PPIs like KONVOMEP. Educating patients about the benefits and proper use of these medications can drive market growth and improve patient outcomes[1].

Cost and Accessibility

Lower Out-of-Pocket Costs

KONVOMEP offers lower out-of-pocket costs for eligible patients through various co-pay programs. This can make the medication more accessible and increase its adoption rate, contributing to its financial trajectory[5].

Conclusion

KONVOMEP is poised for significant growth within the proton pump inhibitors market due to its unique formulation, FDA approval, and the increasing demand for effective treatments for gastrointestinal disorders. The market dynamics, driven by expanding market reach, innovative product approvals, and a focus on patient education, position KONVOMEP for a strong financial trajectory.

Key Takeaways

• Unique Formulation: KONVOMEP is the only FDA-approved omeprazole formulation dispensed as a liquid, catering to patients with swallowing difficulties.
• Market Growth: The proton pump inhibitors market is expected to grow to $4.12 billion by 2028, driven by increasing prevalence of gastrointestinal disorders and market expansion.
• Innovative Approvals: FDA approval of KONVOMEP in 2022 highlights the importance of innovative products in driving market growth.
• Patient Education: Initiatives focused on patient education are crucial for increasing the adoption of PPIs like KONVOMEP.
• Cost and Accessibility: Lower out-of-pocket costs through co-pay programs enhance the accessibility and attractiveness of KONVOMEP.

FAQs

What is KONVOMEP used for?

KONVOMEP is used for the treatment of active benign gastric ulcers in adults, particularly beneficial for those who have difficulty swallowing tablets or capsules.

What makes KONVOMEP unique?

KONVOMEP is the only FDA-approved omeprazole formulation dispensed as a liquid, making it easier for patients with swallowing difficulties to take their medication.

How is the market for proton pump inhibitors expected to grow?

The proton pump inhibitors market is expected to grow from $3.3 billion in 2023 to $4.12 billion by 2028, with a CAGR of 4.6%.

What factors drive the demand for KONVOMEP?

The demand for KONVOMEP is driven by the increasing prevalence of gastrointestinal disorders, innovative product approvals, and initiatives focused on patient education.

How does KONVOMEP help in reducing costs for patients?

KONVOMEP offers lower out-of-pocket costs for eligible patients through various co-pay programs like eVoucherRx™ and Voucher on Demand™.

Sources

1. Proton Pump Inhibitors Global Market Size & Competitors - Research and Markets
2. Provider Updates | Health and Human Services North Dakota - North Dakota Health and Human Services
3. Competition in Prescription Drug Markets, 2017-2022 - ASPE
4. Omeprazole And Antihistamine Market Size & Share Analysis - Mordor Intelligence
5. Stomach ulcer and gastrointestinal treatment with KONVOMEP® - Konvomep.com