MUPIROCIN - Generic Drug Details

What are the generic drug sources for mupirocin and what is the scope of patent protection?

Mupirocin is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Padagis Us, Encube, Fougera Pharms, Glenmark Pharms, Padagis Israel, Sun Pharma Canada, Teva, Alembic, Amneal, and Glenmark Pharms Inc, and is included in sixteen NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for mupirocin. Twenty suppliers are listed for this compound.

Summary for MUPIROCIN

US Patents:	0
Tradenames:	3
Applicants:	11
NDAs:	16
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	89
Patent Applications:	7,331
Drug Prices:	Drug price trends for MUPIROCIN
Drug Sales Revenues:	Drug sales revenues for MUPIROCIN
What excipients (inactive ingredients) are in MUPIROCIN?	MUPIROCIN excipients list
DailyMed Link:	MUPIROCIN at DailyMed

See drug prices for MUPIROCIN

See drug sales revenues for MUPIROCIN

Recent Clinical Trials for MUPIROCIN

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

Sponsor	Phase
Boston Children's Hospital	PHASE4
Adam Olson	PHASE2
Pittsburgh Cure Sarcoma	PHASE2

See all MUPIROCIN clinical trials

Pharmacology for MUPIROCIN

Drug Class	RNA Synthetase Inhibitor Antibacterial
Mechanism of Action	RNA Synthetase Inhibitors

Medical Subject Heading (MeSH) Categories for MUPIROCIN

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for MUPIROCIN

D06AX	Other antibiotics for topical use
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

R01AX	Other nasal preparations
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

US Patents and Regulatory Information for MUPIROCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glenmark Pharms Inc	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	201587-001	Jan 24, 2013	AB	RX	No	Yes
Sun Pharma Canada	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	207116-001	Apr 27, 2020	AB	RX	No	No
Amneal	MUPIROCIN	mupirocin calcium	CREAM;TOPICAL	214811-001	Nov 15, 2022	AB	RX	No	No
Teva	MUPIROCIN	mupirocin	OINTMENT;TOPICAL	065085-001	Nov 7, 2003	AB	RX	No	No
Glaxosmithkline	BACTROBAN	mupirocin	OINTMENT;TOPICAL	050591-001	Dec 31, 1987		DISCN	Yes	No

Expired US Patents for MUPIROCIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Padagis Us	CENTANY	mupirocin	OINTMENT;TOPICAL	050788-001	Dec 4, 2002	6,013,657

Market Dynamics and Financial Trajectory for Mupirocin

Last updated: July 27, 2025

Introduction

Mupirocin, a topical antibiotic primarily used to eradicate nasal colonization of Staphylococcus aureus, including methicillin-resistant strains (MRSA), has sustained significance within infectious disease management. Since its initial approval, mupirocin's pharmaceutical landscape has evolved, governed by intricate market dynamics, regulatory shifts, and emergent antimicrobial resistance concerns. This analysis examines mupirocin's current market environment, projected financial trajectory, and strategic considerations shaping its future.

Pharmaceutical Profile and Regulatory Status

Mupirocin (marketed as Bactroban among others) was first approved by the FDA in 1983. Its mechanism of action involves selective inhibition of bacterial isoleucyl-tRNA synthetase, leading to bacteriostatic effects. This specificity underpins its utility against Gram-positive pathogens, notably MRSA, for both skin infections and decolonization procedures.

Historically, mupirocin's patent exclusivity extended into the early 2000s, but generic formulations now dominate, significantly influencing pricing and market competition. Regulatory adaptations, particularly for nasal application indications, expanded mupirocin's utilization scope, reinforcing its prominence.

Market Dynamics

Demand Drivers

1. Antimicrobial Resistance (AMR): The rise of multidrug-resistant S. aureus strains, especially MRSA, escalates mupirocin's importance in infection control protocols. Healthcare settings prioritize nasal decolonization strategies to curb infection rates, elevating demand[^1].

2. Hospital Infection Control Policies: Regulatory agencies advocate for comprehensive MRSA management. Mupirocin's role in preoperative decolonization and eradication protocols sustains hospital procurement volumes.

3. Limited Competition: While generic formulations dominate, no direct alternatives precisely replace mupirocin's efficacy in nasal decolonization. This unique positioning ensures a steady demand.

4. Global Expansion: Increasing adoption in emerging markets, driven by growing inpatient healthcare investments and global antimicrobial stewardship initiatives, broadens the market base.

Supply Side Factors

1. Pricing Pressure: Generic competition results in declining per-unit prices. However, the high volume of prescriptions maintains revenue streams for manufacturers.

2. Manufacturing Challenges: The production complexity, especially for nasal formulations requiring specialized stability and delivery systems, influences supply stability and costs.

3. Regulatory Challenges: Ongoing concerns over antibiotic stewardship and antimicrobial resistance prompt regulatory scrutiny, which could affect approval processes for new formulations or indications.

Competitive Landscape

Several pharmaceutical companies produce generic mupirocin, including Teva, Sandoz, and Mylan. Limited innovation activity has led to a mature market, with growth primarily driven by volume rather than price increases.

Clinical and Regulatory Trends

Emerging data suggest potential resistance development against mupirocin, threatening long-term efficacy[^2]. Additionally, regulatory agencies are emphasizing stewardship to prevent resistance proliferation, possibly restricting usage or requiring new formulations with enhanced properties.

Financial Trajectory

Revenue Trends

The global mupirocin market was valued at approximately USD 370 million in 2021, with projections indicating a compound annual growth rate (CAGR) of 3-5% through 2028[^3]. Market expansion is tempered by price competition and the impact of antimicrobial resistance.

Market Segmentation

• By Application: Decolonization procedures (~60%), skin infections (~40%).
• By Region: North America remains the largest market (~50%), followed by Europe (~25%) and Asia-Pacific (~15%). The Asia-Pacific region exhibits significant growth potential due to healthcare infrastructure expansion.

Key Growth Drivers

• Increasing adoption of nasal mupirocin for MRSA decolonization.
• Rising hospital-acquired infection control initiatives.
• Implementation of guidelines endorsing mupirocin in preoperative protocols.
• Rising healthcare expenditure in emerging markets.

Market Challenges

• Potential resistance leading to diminished clinical utility.
• Regulatory pressures to minimize antibiotic overuse.
• Competition from alternative therapies and preventive measures, such as vaccines.

Forecast Outlook

Given current conditions, mupirocin's global revenues are expected to experience steady but modest growth. Market resilience hinges on balancing effective stewardship with sustained clinical demand. Companies investing in resistance surveillance and formulation innovation—such as sustained-release devices or combined therapies—may augment their market share.

Strategic Considerations

1. Innovation: Development of formulations with reduced resistance potential or alternative delivery systems could offset declining prices and extend product lifecycle.

2. Stewardship Programs: Collaborating with healthcare entities to promote optimal use aligns with regulatory expectations and sustains demand.

3. Geographic Expansion: Penetrating emerging markets with tailored marketing strategies could drive volume growth.

4. Regulatory Engagement: Active involvement in policy discussions regarding antimicrobial use will position manufacturers favorably for future approvals.

Conclusion

Mupirocin’s market remains anchored by its critical role in infection control amidst a landscape of generics and rising antimicrobial resistance. Demand persists with steady growth prospects, predominantly driven by infection prevention initiatives within healthcare settings. Nonetheless, its financial trajectory faces headwinds from resistance development and regulatory oversight, necessitating innovation and strategic agility. Companies that adapt to these dynamics—through formulation improvements, stewardship alignment, and broader geographic penetration—can maximize long-term value.

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Key Takeaways

• Consistent Demand: Mupirocin remains vital in MRSA decolonization, securing stable prescription volumes despite generic competition.

• Price Competition: Generic proliferation drives down prices; revenue growth relies on volume rather than premium pricing.

• Emergent Resistance: Rising mupirocin resistance poses a threat to long-term utility, prompting the need for novel formulations and stewardship.

• Regional Growth: Developing healthcare infrastructure, especially in Asia-Pacific, offers new avenues for market expansion.

• Innovation and Regulation: Future success depends on balancing innovation with regulatory compliance and antimicrobial stewardship efforts.

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FAQs

1. What factors influence mupirocin's market growth?
Demand from infection control protocols, hospital adoption rates, emerging resistance patterns, and geographic expansion drive growth, while price pressures and resistance undermine it.

2. How is antimicrobial resistance affecting mupirocin's market?
Resistance reduces mupirocin's effectiveness, leading to cautious prescribing and potential restrictions, which may curtail demand and influence development incentives.

3. Are there new formulations of mupirocin under development?
Research is ongoing into sustained-release formulations and combination therapies to enhance efficacy and reduce resistance development.

4. How does the regulatory environment impact mupirocin sales?
Stringent antimicrobial stewardship policies and approval restrictions can limit prescribing, affecting revenue streams.

5. What are the key opportunities for companies in this market?
Developing resistance-resistant formulations, expanding into emerging markets, and collaborating on stewardship initiatives offer strategic growth pathways.

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References

[^1]: CDC. "Management of Multidrug-Resistant Organisms in Healthcare Settings." 2020.
[^2]: Liu, C. et al., "Emerging Resistance to Mupirocin in MRSA," Antimicrobial Agents and Chemotherapy, 2021.
[^3]: MarketsandMarkets. "Antimicrobial Market by Type, Application, and Geography," 2022.