BACTROBAN Drug Patent Profile

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

Bactroban is a drug marketed by Glaxosmithkline and is included in three NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bactroban

A generic version of BACTROBAN was approved as mupirocin by PADAGIS ISRAEL on November 7^th, 2003.

Summary for BACTROBAN

US Patents:	0
Applicants:	1
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	19
Drug Prices:	Drug price information for BACTROBAN
What excipients (inactive ingredients) are in BACTROBAN?	BACTROBAN excipients list
DailyMed Link:	BACTROBAN at DailyMed

See drug prices for BACTROBAN

See drug sales revenues for BACTROBAN

Recent Clinical Trials for BACTROBAN

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

Sponsor	Phase
Lindenhofgruppe AG	Phase 4
Lindenhof AG	Phase 4
Indiana University	Phase 2

See all BACTROBAN clinical trials

US Patents and Regulatory Information for BACTROBAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	BACTROBAN	mupirocin calcium	CREAM;TOPICAL	050746-001	Dec 11, 1997		DISCN	Yes	No
Glaxosmithkline	BACTROBAN	mupirocin calcium	OINTMENT;NASAL	050703-001	Sep 18, 1995		DISCN	Yes	No
Glaxosmithkline	BACTROBAN	mupirocin	OINTMENT;TOPICAL	050591-001	Dec 31, 1987		DISCN	Yes	No

Expired US Patents for BACTROBAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	BACTROBAN	mupirocin calcium	CREAM;TOPICAL	050746-001	Dec 11, 1997
Glaxosmithkline	BACTROBAN	mupirocin calcium	OINTMENT;NASAL	050703-001	Sep 18, 1995
Glaxosmithkline	BACTROBAN	mupirocin calcium	CREAM;TOPICAL	050746-001	Dec 11, 1997

International Patents for BACTROBAN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	0727979
Czech Republic	9601120
Spain	544329
China	1102410
Finland	84179

Market Dynamics and Financial Trajectory for BACTROBAN (Mupirocin)

Last updated: July 28, 2025

Introduction

BACTROBAN, the brand name for mupirocin, is an established topical antibiotic primarily used to eradicate bacterial colonization and treat skin infections, notably Staphylococcus aureus including MRSA (Methicillin-resistant Staphylococcus aureus). Its significance in antimicrobial therapy and its market evolution underscore its strategic importance within the pharmaceutical landscape. This analysis explores the current market dynamics, key growth drivers, competitive factors, and the financial trajectory of BACTROBAN, providing insights for industry stakeholders.

Market Overview and Demand Drivers

Therapeutic Positioning and Clinical Usage

Mupirocin's efficacy against gram-positive bacteria, especially in nasal decolonization of MRSA, positions BACTROBAN as a frontline topical agent. Its indications extend from skin infections to eradicating nasal carriage in both hospital and community settings, a critical factor amidst rising antibiotic resistance. The FDA-approved indications grant it a unique position, with an established safety and efficacy profile.

Global Incidence of Skin and Nasal Infections

The increasing prevalence of skin infections and MRSA colonization drives demand for mupirocin. According to the CDC, approximately 1.5 million Staphylococcus aureus infections occur annually in the U.S., with a significant fraction involving resistant strains. The global burden of mupirocin-sensitive infections sustains steady demand, particularly in healthcare settings emphasizing infection control protocols.

Antibiotic Resistance and Empirical Use

Rising antibiotic resistance elevates the importance of targeted therapies like mupirocin. Its role in nasal decolonization protocols for high-risk hospitalized patients enhances its utilization. However, emerging resistance to mupirocin itself remains a concern, potentially affecting future market expansion.

Market Dynamics Influencers

Competitive Landscape

• Existing Market Entrants: BACTROBAN’s primary competition arises from generic mupirocin formulations, which have eroded the original brand's market share over the last decade. Major pharmaceutical companies have introduced generics post-patent expiry, reducing pricing power and profit margins.

• Innovation and Formulation Development: Innovations such as combination therapies or alternative delivery systems are limited, which constrains differentiation. Conversely, the absence of significant innovation increases reliance on established formulations, favoring generic proliferation.

Regulatory Environment

• Patent and Exclusivity Status: BACTROBAN's primary patent expired in the early 2000s, facilitating generic entry. Subsequent patent challenges and regulatory pathways have moderated the impact of exclusivity, intensifying price competition.

• Global Approvals and Off-Label Uses: Regulatory approvals in emerging markets expand potential revenue streams, but off-label use limitations are monitored by authorities, impacting clinical utilization.

Pricing and Reimbursement Strategies

Reimbursement policies significantly influence sales, especially in hospital administrations. Competitive pricing of generics constrains the brand's pricing strategy, emphasizing volume sales over profit margins.

Financial Trajectory and Revenue Projections

Revenue Trends

Post-patent expiry, BACTROBAN experienced a decline in sales due to generic competition. However, in specific markets with high MRSA prevalence and strict infection control protocols, the brand maintains niche dominance, allowing it to sustain a stable revenue base.

Market Penetration and Market Share

In North America and Europe, the brand’s market share has declined to negligible levels against generics. Nevertheless, in select regions with limited generic penetration and high infection-related treatment needs, BACTROBAN continues to command meaningful sales.

Impact of Antimicrobial Stewardship

Antibiotic stewardship programs aim to optimize antimicrobial use, which could restrict unnecessary mupirocin prescriptions, impacting sales volumes. Conversely, targeted decolonization protocols in hospitals may bolster demand where integrated into infection control policies.

Potential Revenue Growth Factors

• New Indications: Expanding approvals for additional indications, such as certain nasal carriage or complex skin infections, could foster growth.
• Market Expansion: Penetration into emerging economies, where antibiotic resistance is rising and healthcare infrastructure is expanding, offers future revenue opportunities.
• Formulation Innovations: Developing sustained-release or combination formulations might differentiate BACTROBAN, enabling premium pricing and increased market share.

Future Outlook and Strategic Considerations

The financial future of BACTROBAN hinges on navigating resistance patterns, regulatory landscapes, and competitive forces:

• Monitoring Resistance Trends: The emergence of mupirocin-resistant strains could diminish efficacy expectations, necessitating strategic shifts toward combination therapies or molecular modifications.

• Strategic Partnerships: Licensing agreements, co-marketing with hospital procurement programs, or collaborations with infection control initiatives could enhance sales.

• Pipeline Development: Investment in novel formulations or delivery systems may rejuvenate the brand's market appeal and expand its therapeutic utility.

Conclusion

While the BACTROBAN brand faces significant challenges from generic competition and resistance trends, niche applications, infection control protocols, and expansion in emerging markets sustain its market presence. Its financial outlook depends on strategic innovations, geographic expansion, and stewardship policy impacts. For pharmaceutical firms and investors, understanding these dynamics is crucial for informed decision-making.

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Key Takeaways

• Market backbone: BACTROBAN remains vital in treating skin infections and nasal decolonization, especially where MRSA prevalence is high.
• Competitive pressure: Post-patent expiry, generic mupirocin dominates, compressing margins and sales revenue.
• Resistance concern: Emerging mupirocin resistance threatens future usage, prompting the need for innovation.
• Growth avenues: Strategic expansion into emerging markets and pipeline diversification offer growth potential.
• Stewardship impact: Antibiotic stewardship programs could limit use but also promote targeted applications in healthcare settings.

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FAQs

1. What factors have most impacted BACTROBAN's market share?
The expiration of patent protections led to the proliferation of generic mupirocin formulations, significantly eroding brand sales. Additionally, rising mupirocin resistance and restrictive prescribing due to stewardship programs have further limited growth.

2. How does mupirocin resistance affect BACTROBAN’s future?
Resistance diminishes therapeutic efficacy, reducing demand. The emergence of resistant strains could necessitate alternative treatments or formulation modifications, impacting brand viability.

3. Are there opportunities for BACTROBAN in emerging markets?
Yes. As healthcare infrastructure expands and antibiotic resistance increases, emerging markets present opportunities for BACTROBAN’s use, especially with tailored pricing strategies and local regulations.

4. What innovations could enhance BACTROBAN's market trajectory?
Development of combination therapies, sustained-release formulations, or new indications could differentiate BACTROBAN, driving revenue and extending its lifecycle.

5. How do infection control programs influence BACTROBAN sales?
Mandatory nasal decolonization and skin infection protocols in hospitals sustain demand for mupirocin. Effective infection control enhances application scope, supporting steady sales in healthcare settings.

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Sources

[1] Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019.
[2] World Health Organization. Global Antimicrobial Resistance Surveillance System.
[3] U.S. Food and Drug Administration. Mupirocin (Bactroban) approval and patent information.
[4] Market research reports on topical antibiotics and antimicrobial resistance trends.
[5] Industry patent filings and FDA drug approval databases.