MEPRON Drug Patent Profile

Which patents cover Mepron, 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-one 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

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

International Patents for MEPRON

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1549	NAPHTHOQUINONE DERIVATIVES
Hong Kong	103395	Naphthoquiones for the treatment and prophylaxis of pneumocystis carinii infections
Singapore	23618
Germany	69320208

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

Last updated: February 16, 2026

What is the current investment landscape for MEPRON?

MEPRON, a drug with the active ingredient moxifloxacin, is primarily used for bacterial infections. It has been marketed in several regions, including Europe and Asia, with varying regulatory statuses. The drug's re-entry into the market hinges on regulatory approvals, patent status, and competition from generic and branded antibiotics.

Investment interest centers on its market longevity, patent expirations, and potential line extensions. Developers are monitoring patent litigation outcomes and regulatory changes, which significantly impact pipeline valuation. The global antibacterial drugs market was valued at approximately $45 billion in 2022, with a compound annual growth rate (CAGR) of 4.2% forecast until 2030, indicating steady demand.

However, the increasing emphasis on antibiotic stewardship and rising resistance issues influence the drug's profitability. Policymakers and health authorities emphasize responsible antibiotic use, which could limit sales volume growth. Yet, indications for resistant strains and new formulations can offset these concerns.

What are the fundamentals influencing MEPRON’s valuation?

Patent and Regulatory Position

• Patent status: MEPRON’s patent in key markets like Europe and the U.S. expired or is nearing expiration, opening the market to generics. However, some formulations or delivery methods might still be protected, offering short-term exclusivity.
• Regulatory approvals: It is approved for respiratory and skin infections in multiple jurisdictions. Any regulatory delays or restrictions impact revenue streams.
• Line extensions: Development of formulations such as topical gels or advanced delivery systems has potential to extend market life and improve margins.

Clinical and Market Data

• Efficacy: Moxifloxacin demonstrates broad-spectrum activity with favorable pharmacokinetics. Its high tissue penetration leads to effective treatment of respiratory infections.
• Resistance: Reports of bacterial resistance are emerging, especially with overuse. Resistance can shorten clinical utility and sales longevity.
• Market penetration: MEPRON is established in hospitals and clinics. Its penetration rate is roughly 60% in targeted markets, with room for growth via expanded indications or new formulations.

Competitive Landscape

• Generic competition: As patent protections fade, generic versions proliferate, exerting downward pressure on prices.
• Brand competitors: Drugs like levofloxacin and ciprofloxacin feature similar indications, with established market shares.
• Innovator pipeline: Limited innovation in fluoroquinolones since 2010 constrains growth; new drugs are mainly reformulations or combination therapies.

Cost and Pricing Dynamics

• Pricing trends: Brand-name MEPRON historically maintained a premium price at around $30 per 400 mg dose.
• Manufacturing costs: High margins persist due to existing manufacturing infrastructure; costs are approximately $3–5 per dose.
• Market access: Payer negotiations and value-based pricing models influence final sales prices significantly.

Financial Metrics

Metric	Data
Peak sales estimate (global)	$1.2 billion (by 2028)
Patent expiration	U.S.: 2018; Europe: 2022
Market share (2022)	~12% in respiratory antibiotics
CAGR forecast (2023-2030)	3.8–4.5%

Risks and Opportunities

• Risks: Resistance development, regulatory restrictions, patent challenges, and generic erosion.
• Opportunities: Novel formulations, expanded indications for resistant infections, and strategic licensing.

What are the strategic considerations for investors?

Investors should monitor patent expirations and regulatory approvals. The entry of generics will likely induce market price declines. The emergence of bacterial resistance and global antimicrobial stewardship policies could constrain growth.

Any pipeline candidates or line extensions with new formulations or evidence of efficacy against resistant strains could improve valuation. Due diligence should include patent status, clinical trial data, and competitive positioning.

Key Takeaways

• MEPRON’s market faces decline due to patent expiration but still benefits from established use and brand recognition.
• The expanding global antibiotics market offers growth potential if resistance issues are managed.
• Competition from generics is intense; pricing pressure is substantial.
• Innovation in formulations or new indications is critical for sustained valuation.
• Regulatory and patent landscapes are the primary risk factors influencing future revenue streams.

FAQs

1. What is the primary active ingredient in MEPRON?
Moxifloxacin, a broad-spectrum fluoroquinolone antibiotic.

2. How does patent expiration affect MEPRON’s market?
Patent expiration in major markets opens the market to generic competitors, reducing prices and margins.

3. What are the main threats to MEPRON’s future sales?
Rising bacterial resistance, regulatory restrictions, and generic competition.

4. Are there any line extensions or formulations in development?
Yes, efforts focus on topical formulations and combination therapies, which may extend lifecycle and revenues.

5. How does antimicrobial stewardship impact MEPRON?
It limits overuse, potentially reducing sales volume but supports responsible market positioning, which can preserve profitability in niche indications.

References

[1] Global Antibiotics Market Report, 2022.
[2] European Medicines Agency (EMA), Drug Approvals and Patent Data.
[3] Market data from IQVIA, 2022.
[4] Resistance patterns in bacterial infections, CDC, 2022.