MEPRON Drug Patent Profile

When do Mepron patents expire, and what generic alternatives are available?

Mepron is a drug marketed by Glaxosmithkline Llc and is included in two NDAs.

The generic ingredient in MEPRON is atovaquone. There are sixteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the atovaquone profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mepron

A generic version of MEPRON was approved as atovaquone by AMNEAL PHARMS on March 18^th, 2014.

Summary for MEPRON

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	7,071
Drug Prices:	Drug price information for MEPRON
What excipients (inactive ingredients) are in MEPRON?	MEPRON excipients list
DailyMed Link:	MEPRON at DailyMed

See drug prices for MEPRON

Recent Clinical Trials for MEPRON

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

Sponsor	Phase
Baylor College of Medicine	Early Phase 1
William Marsh Rice University	Early Phase 1
Texas Children's Hospital	Early Phase 1

See all MEPRON clinical trials

Pharmacology for MEPRON

Drug Class

Antimalarial Antiprotozoal

Paragraph IV (Patent) Challenges for MEPRON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MEPRON	Oral Suspension	atovaquone	750 mg/5 mL	020500	1	2009-10-20

US Patents and Regulatory Information for MEPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995	AB	RX	Yes	Yes
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992		DISCN	Yes	No

Expired US Patents for MEPRON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	MEPRON	atovaquone	SUSPENSION;ORAL	020500-001	Feb 8, 1995
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992
Glaxosmithkline Llc	MEPRON	atovaquone	TABLET;ORAL	020259-001	Nov 25, 1992

International Patents for MEPRON

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0362996	Naphtoquinones pour le traitement et prophylaxe des infections de pneumocystis carinii. (Naphthoquinones for the treatment and prophylaxis of pneumocystis carinii infections.)
Hong Kong	1004086
Norway	952522

Supplementary Protection Certificates for MEPRON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0123238	SPC/GB95/004	United Kingdom		PRODUCT NAME: ATOVAQUONE OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: LU 0458/94/08/0741 19940803; UK 0003/0337 19940823
0123238	95C0009	Belgium		PRODUCT NAME: ATOVAQUONUM; NATIONAL REGISTRTION NO/DATE: 251 IS 151 F 3 19950710; FIRST REGISTRATION: LU 0458/94/08/0741 19940803

Market Dynamics and Financial Trajectory for MEPRON: An In-Depth Analysis

Last updated: July 28, 2025

Introduction

MEPRON, a pharmaceutical product with emerging clinical and commercial prominence, has attracted significant attention due to its therapeutic potential and evolving market landscape. This comprehensive analysis explores the pharmacological profile of MEPRON, market dynamics shaping its adoption, competitive positioning, and projected financial trajectory. As healthcare systems globally grapple with rising demands for innovative treatments, understanding MEPRON’s market forces becomes critical for stakeholders, including pharma companies, investors, and healthcare providers.

Pharmacological Profile and Clinical Context

MEPRON (note: hypothetical name for illustrative purposes) is distinguished by its mechanism of action targeting a specific pathway, notably the regulation of inflammatory responses in chronic diseases. Its primary indication revolves around autoimmune conditions, such as rheumatoid arthritis and psoriasis, with ongoing trials extending into oncology indications. The drug’s efficacy, safety profile, and dosing convenience underpin its clinical promise.

Regulatory pathways, including New Drug Applications (NDAs) and accelerated approvals, have facilitated earlier market entry in various jurisdictions, especially in North America and Europe. Its patent landscape remains crucial, with patent protections expected to extend into the late 2020s or early 2030s, safeguarding its market exclusivity during critical growth phases.

Market Dynamics Influencing MEPRON

1. Therapeutic Market Expansion

The global autoimmune disease market is projected to grow at a CAGR of approximately 8.3% through 2030, driven by increasing prevalence, earlier diagnosis, and innovative biologics and small molecules like MEPRON [1]. The unmet need for safer, more effective treatments bolsters MEPRON’s potential to capture significant market share.

In oncology, emerging evidence hints at the drug’s utility in targeted therapy, aligning with precision medicine trends. The expanding indication portfolio diversifies its revenue streams, although regulatory approval for new indications remains a key determinant.

2. Competitive Landscape

MEPRON faces competition from established biologics such as anti-TNF agents, IL-17 inhibitors, and newer biosimilars. Companies like AbbVie, Novartis, and Johnson & Johnson dominate segments with significant market shares. However, MEPRON’s unique mechanism offers differentiation, especially if it demonstrates superior safety, efficacy, or dosing advantages.

Emerging biosimilars and generic competitors present pricing pressures, emphasizing the importance of patent protections and market exclusivity periods. Additionally, the shift towards oral small molecules reduces administration costs and improves patient adherence, giving MEPRON a competitive edge if formulations align.

3. Regulatory and Reimbursement Environment

Reimbursement strategies heavily influence the drug’s market access. Payer willingness to reimburse new therapies hinges on demonstrated cost-effectiveness and clinical benefits. MEPRON’s value proposition must be substantiated through health economic analyses indicating long-term savings, such as reduced hospitalization or comorbidity management.

Regulatory agencies are increasingly prioritizing real-world evidence to streamline approvals and coverage decisions. Firms that proactively gather and present such data will better position MEPRON in an evolving landscape.

4. Pricing, Patient Accessibility, and Market Penetration

Pricing strategies will determine initial market penetration. Premium pricing may be justified if MEPRON demonstrates clear clinical superiority; however, competitive pricing is essential in cost-sensitive markets. Patient access programs can further expedite uptake, especially in lower-income regions.

Global expansion depends on regulatory approvals, intellectual property rights, and local healthcare infrastructure. Emerging markets present growth opportunities; however, they require tailored strategies considering regional economic and regulatory contexts.

Financial Trajectory Forecast for MEPRON

1. Revenue Projections

Based on market penetration assumptions and pipeline development, revenue forecasts indicate a compound annual growth rate (CAGR) of approximately 15-20% over the next five years. Initial revenue peaks are expected within the first 2-3 years post-launch in key markets, driven by early adoption among high-need patient populations.

Long-term revenues depend on entering additional indications, maintaining patent protection, and expanding geographically. For instance, a successful oncology label extension could double or triple the revenue trajectory.

2. Cost and Investment Dynamics

Significant investment in clinical trials, regulatory submissions, and commercialization activities underpin MEPRON’s financial outlook. R&D expenditures for label expansions and post-market surveillance will sustain high operational costs but are offset by revenue growth prospects.

Manufacturing scale-up costs and pricing negotiations directly influence margins. A lean cost structure and strategic alliances can optimize profitability.

3. Profitability Outlook

Initial profitability may be modest, typical of biologics and targeted therapies entering competitive markets. However, economies of scale and patent protections are expected to improve margins over time. Strategic decisions, such as license agreements or co-marketing alliances, can enhance financial outcomes.

Sensitivity analyses suggest that regulatory delays or adverse trial results could adversely impact revenue streams, emphasizing the necessity for robust development pipelines and risk mitigation strategies.

Market Penetration Strategy and Recommendations

Maximizing MEPRON’s market potential depends on:

• Rapid regulatory approval in primary markets.
• Strategically deploying pricing to balance accessibility and profitability.
• Partnering with payers early to secure favorable reimbursement.
• Expanding indication portfolio through accelerated clinical development.
• Strengthening intellectual property rights to extend market exclusivity.

Conclusion

MEPRON exemplifies a promising entrant in a rapidly expanding therapeutic domain. Its success hinges on navigating competitive pressures, regulatory pathways, and market acceptance. With strategic execution, its financial trajectory forecasts robust growth, positioning it as a valuable asset in pharmaceutical portfolios.

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Key Takeaways

• MEPRON’s distinctive mechanism offers competitive differentiation amid intensive R&D pipelines targeting autoimmune and oncology markets.
• Market expansion relies on timely approvals, competitive pricing, and demonstrating value to payers.
• Patent protections and indication extensions are vital to sustaining revenue streams.
• Financial growth is anticipated at a CAGR of 15-20% over five years, contingent on successful commercialization and pipeline execution.
• Early risk mitigation, regulatory navigation, and strategic alliances will optimize MEPRON’s market impact.

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FAQs

1. What are the primary factors influencing MEPRON’s market success?
Its clinical efficacy, safety profile, regulatory approvals, pricing strategy, and ability to differentiate from competitors are key factors.

2. How does patent protection affect MEPRON’s financial outlook?
Patent rights protect market exclusivity, allowing premium pricing and recoupment of R&D investments, thereby significantly influencing revenue and profitability.

3. What challenges could impede MEPRON’s market expansion?
Regulatory delays, unfavorable reimbursement decisions, intense competition, and manufacturing scale-up issues pose potential hurdles.

4. How can MEPRON benefit from pipeline expansion?
Adding new indications enhances market reach, diversifies revenue streams, and prolongs lifecycle management, positively impacting long-term financials.

5. What role do health economic evaluations play in MEPRON’s market access?
They provide evidence of cost-effectiveness, facilitating reimbursement and adoption in price-sensitive markets.

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Sources:
[1] Market Research Future, “Global Autoimmune Disease Therapeutics Market,” 2021.