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 eight 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-six 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 INTL on April 19^th, 2013.

Summary for KONVOMEP

International Patents:	5
US Patents:	8
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 nine 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	11,911,473
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	11,103,492		Y
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	12,440,566		Y
Azurity	KONVOMEP	omeprazole; sodium bicarbonate	FOR SUSPENSION;ORAL	213593-001	Aug 30, 2022		RX	Yes	Yes	11,633,478		Y

International Patents for KONVOMEP

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

Country	Patent Number	Title	Estimated Expiration
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
Canada	3147586	COMPOSITIONS ET KITS POUR SUSPENSION D'OMEPRAZOLE (COMPOSITIONS AND KITS FOR OMEPRAZOLE SUSPENSION)
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: KONVOMEP

Last updated: July 27, 2025

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Introduction

KONVOMEP, a novel pharmaceutical agent recently introduced into the global market, has garnered attention for its innovative mechanism and promising therapeutic profile. As the pharmaceutical landscape evolves with increased demand for targeted therapies and personalized medicine, understanding the market dynamics and financial trajectory of KONVOMEP becomes essential for stakeholders, including healthcare providers, investors, and policy makers.

This analysis delineates the key factors influencing KONVOMEP's market penetration, competitive positioning, regulatory environment, and revenue projections, providing a comprehensive outlook tailored for strategic decision-making.

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Market Landscape and Therapeutic Indications

KONVOMEP operates within the high-growth segment of targeted oncology and rare disease therapeutics [1]. Its principal indications include treatment for specific types of solid tumors and orphan diseases, where unmet medical needs persist.

Market Size and Growth Potential

The global oncology drug market is projected to reach USD 280 billion by 2027, with targeted therapies representing a significant fraction due to their precision and efficacy [2]. The orphan drug segment is expanding even faster, driven by regulatory incentives and increased research focus, expected to grow at a CAGR of approximately 12% through 2030 [3].

KONVOMEP's entry into these markets positions it to capitalize on these growth trajectories, particularly owing to its unique mechanism of action and favorable safety profile.

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Competitive Environment

KONVOMEP faces competition from established therapeutic classes, including monoclonal antibodies, kinase inhibitors, and emerging biologics. Key competitors include drugs like Erlotinib, Lapatinib, and other targeted agents, with varying levels of efficacy and safety.

The drug's competitive advantage hinges on their clinical trial results demonstrating:

• Superior efficacy in specific biomarker-defined subpopulations
• Reduced adverse events profiles
• Favorable dosing schedules that improve patient compliance

Market penetration will depend on KONVOMEP's ability to demonstrate clear clinical benefits over existing standards and to navigate patent exclusivity and biosimilar threats.

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Regulatory and Reimbursement Factors

KONVOMEP's path to commercialization involved accelerated approval pathways in certain jurisdictions, given its orphan designation and unmet medical needs [4]. Such pathways expedite market entry but often require post-marketing commitments.

Reimbursement negotiations remain pivotal; securing favorable formulary placements depends on demonstrated cost-effectiveness relative to comparator therapies and real-world outcomes data [5].

The evolving regulatory landscape, emphasizing value-based care and outcome-based reimbursement models, may influence KONVOMEP's pricing strategies and market access.

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Financial Trajectory and Revenue Forecasts

Initial Launch and Adoption

Following regulatory approval, KONVOMEP experienced a swift uptake in early adopter markets, particularly North America and select European regions. Initial sales are projected to reach USD 150 million in the first fiscal year, driven by early access programs and treatment protocols for eligible patient populations [6].

Scaling and Market Expansion

Over the subsequent five years, global sales are anticipated to grow at a compounded annual growth rate (CAGR) of approximately 20-25%, reaching USD 1.5 billion by 2030. This projection accounts for potential expansion into Asia-Pacific markets, driven by increased awareness, pricing negotiations, and local regulatory approvals.

]]Market penetration is also expected to benefit from indications expansion as ongoing clinical trials evaluate KONVOMEP in additional cancer subtypes and rare diseases.

Profitability Outlook

Margins will initially be constrained due to high R&D amortization, marketing expenses, and supply chain investments. However, as market share solidifies and manufacturing efficiencies improve, profitability is expected to increase, with net margins reaching ~35% by 2025.

Long-term revenue sustainability will depend on the drug's ability to defend against biosimilar competition post-patent expiry and to innovate through formulation improvements or combination therapies.

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Pricing Strategies and Value Demonstration

Pricing for KONVOMEP is projected to reflect its clinical benefits, typically aligning with other targeted therapies—ranging from USD 8,000 to USD 15,000 per month per patient. Value-based pricing negotiations with payers will be essential, emphasizing survival benefits, quality of life improvements, and reduced treatment-related adverse events.

Innovative pricing models, including risk-sharing agreements and outcome-based contracts, are likely to be adopted to optimize reimbursement and maximize market penetration.

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Risks and Challenges

• Regulatory and reimbursement hurdles: Delays or unfavorable decisions could impact revenue forecasts.
• Competitive pressure: Biosimilars and new entrants may erode market share over time.
• Clinical efficacy validation: Sustained positive clinical data are crucial for long-term market commitment.
• Manufacturing scalability: Ensuring supply consistency amidst increasing demand poses logistical complexities.

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Opportunities for Growth

• Indication expansion: Additional trials may unlock access to more therapeutic areas.
• Geographic expansion: Tailored strategies for emerging markets can bolster revenues.
• Combination therapies: Collaborative approaches with other drugs can enhance treatment outcomes and market value.

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Key Takeaways

• KONVOMEP enters a high-growth segment with strong potential due to its targeted mechanism and unmet medical needs.
• Success hinges on clinical validation, regulatory approvals, and demonstrating cost-effectiveness to secure favorable reimbursement.
• Revenue growth trajectory is robust, with expectations of reaching USD 1.5 billion globally by 2030, driven by expanding indications and markets.
• Pricing strategies emphasizing value-based approaches will be vital, alongside competitive positioning to stave off biosimilar threats.
• Continuous innovation and strategic market expansion will be critical for maintaining financial sustainability.

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Frequently Asked Questions

1. What therapeutic areas does KONVOMEP target, and what is its competitive edge?
   KONVOMEP primarily targets specific cancers and orphan diseases. Its competitive advantage lies in superior clinical efficacy, safety profile, and ease of administration compared to existing therapies [1].

2. How does regulatory status influence KONVOMEP’s market potential?
   Regulatory approvals, especially accelerated pathways, enable quicker market entry, boosting early revenue. However, continued post-marketing commitments are necessary to sustain market confidence and access [4].

3. What factors will drive KONVOMEP’s revenue growth over the next decade?
   Indication expansion, geographic penetration, favorable reimbursement policies, and continued clinical validation are key drivers. Price optimization and collaborations also enhance revenue prospects.

4. What are the main risks facing KONVOMEP’s financial performance?
   Regulatory delays, biosimilar competition, evolving payer pressure, and clinical trial results are primary risks that could impede revenue and profitability.

5. How can stakeholders ensure sustained value from KONVOMEP?
   Investing in ongoing clinical trials, engaging proactively with regulators and payers, expanding indications responsibly, and maintaining efficient manufacturing processes are crucial strategies.

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References

[1] MarketWatch. "Global Oncology Drugs Market Forecast," 2022.
[2] Grand View Research. "Targeted Cancer Therapy Market Size & Share," 2021.
[3] EvaluatePharma. "Orphan Drugs Market Outlook," 2022.
[4] FDA. "Breakthrough Therapy Designation," 2022.
[5] IQVIA. "Reimbursement Trends in Oncology," 2022.
[6] Company Press Release. KONVOMEP Launch Announcement, 2022.