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Last Updated: January 29, 2026

Mupirocin calcium - Generic Drug Details


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

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

There are seven drug master file entries for mupirocin calcium. Eight suppliers are listed for this compound.

Summary for mupirocin calcium
US Patents:0
Tradenames:2
Applicants:7
NDAs:8
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 8
Raw Ingredient (Bulk) Api Vendors: 121
Clinical Trials: 3
What excipients (inactive ingredients) are in mupirocin calcium?mupirocin calcium excipients list
DailyMed Link:mupirocin calcium at DailyMed
Recent Clinical Trials for mupirocin calcium

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

SponsorPhase
Perrigo CompanyPhase 3
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
Taro Pharmaceuticals USAPhase 1

See all mupirocin calcium clinical trials

Pharmacology for mupirocin calcium

US Patents and Regulatory Information for mupirocin calcium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Canada MUPIROCIN mupirocin calcium CREAM;TOPICAL 207116-001 Apr 27, 2020 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline BACTROBAN mupirocin calcium CREAM;TOPICAL 050746-001 Dec 11, 1997 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glenmark Pharms Inc MUPIROCIN mupirocin calcium CREAM;TOPICAL 201587-001 Jan 24, 2013 AB RX No Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Glaxosmithkline BACTROBAN mupirocin calcium OINTMENT;NASAL 050703-001 Sep 18, 1995 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Padagis Israel MUPIROCIN mupirocin calcium CREAM;TOPICAL 212465-001 Aug 3, 2022 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Alembic MUPIROCIN mupirocin calcium CREAM;TOPICAL 213053-001 Nov 16, 2021 BX RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Encube MUPIROCIN mupirocin calcium CREAM;TOPICAL 213076-001 Aug 31, 2021 AB RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for mupirocin calcium

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

Market Dynamics and Financial Trajectory for Mupirocin Calcium

Last updated: July 27, 2025

Introduction

Mupirocin calcium, an antibiotic primarily used to eradicate methicillin-resistant Staphylococcus aureus (MRSA) and treat skin infections, has maintained a significant position within the dermatological and hospital antimicrobial markets. As a topical agent, it has gained regulatory approval in numerous jurisdictions, fostering steady demand. This article provides an in-depth analysis of the current market dynamics and financial trajectory of mupirocin calcium, considering factors including clinical relevance, competitive landscape, regulatory influences, and emerging market trends.

Pharmacological Profile and Clinical Significance

Mupirocin calcium effectively inhibits bacterial isoleucyl-tRNA synthetase, impeding bacterial protein synthesis. Its notable efficacy against gram-positive bacteria, especially MRSA, renders it crucial in hospital and outpatient settings for decolonization procedures and skin infections like impetigo. The drug’s application in preventing infection transmission, particularly in surgical wound sites and nasal colonization, underscores its therapeutic importance. Its minimal systemic absorption upon topical application reduces systemic toxicity, further cementing its role in antimicrobial therapy.

Market Drivers

  1. Rising MRSA Prevalence
    The persistent rise of MRSA infections worldwide significantly propels mupirocin calcium demand. According to the CDC, MRSA accounts for considerable morbidity and healthcare costs, emphasizing the need for effective decolonization and topical treatments.

  2. Growing Skin Infection Incidence
    Increasing prevalence of impetigo, folliculitis, and other skin infections spread through community and healthcare settings sustains steady demand. The escalation of these infections, often resistant to traditional antibiotics, enhances mupirocin calcium’s clinical relevance.

  3. Hospital Infection Control Protocols
    Stringent infection control measures in hospitals incorporate mupirocin nasal ointments into protocols to reduce MRSA colonization among healthcare workers and patients, bolstering market value.

  4. Regulatory Approvals and Expanded Indications
    Regulatory agencies, including the FDA and EMA, have approved mupirocin for various topical indications. Expanding approvals and off-label use contribute positively to its market trajectory.

Market Challenges and Competitive Landscape

  1. Antibiotic Resistance Concerns
    Growing resistance to mupirocin, especially high-level resistance observed in some regions, threatens its long-term efficacy. The emergence of mupirocin-resistant strains urges the development of alternative strategies and could restrict its prescribing.

  2. Generic Entry and Price Competition
    Generic mupirocin calcium products have entered multiple markets, exerting downward pressure on prices and profit margins for branded drugs. Cost-conscious healthcare systems favor generics, affecting revenue streams.

  3. Limited New Formulations
    Market players have predominantly focused on topical ointment formulations, with minimal innovation in delivery systems or combination therapies. This limits potential market expansion.

  4. Regulatory and Patent Dynamics
    Patent expiries and evolving regulatory landscapes influence market exclusivity and pricing strategies. Companies must adapt to patent cliffs by innovating or diversifying portfolios.

Financial Trajectory and Market Size

The global mupirocin market was valued at approximately USD 350-400 million in 2022, with projections indicating a compound annual growth rate (CAGR) of around 4-6% over the next five years [1]. North America dominates this market, driven by high MRSA prevalence, advanced healthcare infrastructure, and comprehensive infection control programs. The Asia-Pacific region is poised for rapid growth owing to expanding healthcare access, increasing skin infection cases, and rising antimicrobial resistance concerns.

Key Market Segments

  • Formulation Type: Topical ointments remain predominant, but creams, nasal ointments, and gel formulations are gaining popularity.

  • Application: Decolonization (nasal), skin infections (impetigo, folliculitis), and postoperative wound prophylaxis.

  • End-User: Hospitals, clinics, long-term care facilities, and home healthcare.

Emerging Trends and Future Outlook

  1. Development of Resistance-Resistant Formulations
    Innovative formulations incorporating resistance breakers or combination therapies are under research. These efforts aim to extend the clinical utility of mupirocin.

  2. Targeted Delivery Systems
    Advancements in nanotechnology and targeted delivery could improve efficacy, reduce resistance development, and broaden indications.

  3. Enhanced Market Penetration in Emerging Economies
    As healthcare infrastructure improves, increasing adoption of mupirocin in regions with high infection burdens augurs well for revenue growth.

  4. Strategic Mergers and Acquisitions
    Pharmaceutical companies are consolidating to optimize portfolios and leverage synergies, potentially influencing market dynamics positively.

Regulatory Impact and Patent Landscape

While patents for original formulations have expired or are nearing expiration, patent extensions and secondary patents on specific formulations or delivery mechanisms may offer temporary exclusivity. Regulatory agencies’ evolving stance on antimicrobial stewardship mandates prudent prescribing and could influence market growth.

Pricing and Reimbursement

Price sensitivity, particularly with generic entrants, influences market revenues. Reimbursement policies in key markets like the US, Europe, and Japan significantly impact overall financial potentials. Favorable reimbursement schemes support steady sales, while price pressures remain a concern.

Conclusion

Mupirocin calcium’s market remains robust, driven by its critical role in combating MRSA and skin infections within healthcare settings. Although challenges like resistance and generic competition persist, ongoing innovations and expanding indications suggest a stable financial trajectory. Strategic anticipations include harnessing novel formulations, targeting emerging markets, and reinforcing stewardship practices to sustain growth.


Key Takeaways

  • Market demand remains high due to the persistent prevalence of MRSA and skin infections globally.

  • Resistance development is a key concern that could impact future sales unless addressed through ongoing research.

  • Generic formulations exert significant price competition, influencing profit margins but also expanding access.

  • Regional disparities favor North America and Europe presently, with promising growth in Asia-Pacific markets.

  • Innovation in formulation and targeted delivery systems offers potential to extend the commercial lifespan and therapeutic utility of mupirocin calcium.


FAQs

1. What factors most significantly influence the market growth of mupirocin calcium?
The rise in MRSA infections, hospital infection control protocols, and expanding indications drive market growth, while resistance development and generic competition present challenges.

2. How does antibiotic resistance impact mupirocin calcium’s market?
Resistance reduces the drug’s efficacy, leading clinicians to seek alternative therapies, which can decrease demand and influence development of resistance-resistant formulations.

3. What regions are expected to show the highest growth for mupirocin calcium?
The Asia-Pacific region is projected for rapid growth due to increasing healthcare infrastructure and high infection rates, while North America remains a mature market.

4. Are there any significant patent protections that could extend the product’s exclusivity?
While primary patents have expired, secondary patents on formulations or delivery systems may provide temporary exclusivity, affecting pricing and market control.

5. What are potential avenues for pharmaceutical companies to expand mupirocin calcium’s market share?
Innovations in formulation, combination therapies, exploring new indications, and penetrating emerging markets represent strategic expansion opportunities.


References

[1] MarketWatch, “Global Mupirocin Market Report 2022-2027,” March 2022.

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