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Last Updated: March 27, 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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Encube MUPIROCIN mupirocin calcium CREAM;TOPICAL 213076-001 Aug 31, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Amneal MUPIROCIN mupirocin calcium CREAM;TOPICAL 214811-001 Nov 15, 2022 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline BACTROBAN mupirocin calcium CREAM;TOPICAL 050746-001 Dec 11, 1997 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Padagis Israel MUPIROCIN mupirocin calcium CREAM;TOPICAL 212465-001 Aug 3, 2022 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 5,569,672 ⤷  Start Trial
Glaxosmithkline BACTROBAN mupirocin calcium CREAM;TOPICAL 050746-001 Dec 11, 1997 6,025,389 ⤷  Start Trial
Glaxosmithkline BACTROBAN mupirocin calcium OINTMENT;NASAL 050703-001 Sep 18, 1995 5,569,672 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Mupirocin Calcium: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Mupirocin calcium, a topical antibiotic, faces evolving market dynamics driven by increasing bacterial resistance, the introduction of generic alternatives, and patent expirations. Its financial trajectory is characterized by stable demand for established indications alongside potential growth opportunities in new formulations and therapeutic areas.

What is the Current Market Size and Projected Growth for Mupirocin Calcium?

The global mupirocin calcium market is estimated at approximately $350 million as of 2023. Projected growth is forecast at a compound annual growth rate (CAGR) of 3.5% to 4.2% over the next five years, reaching an estimated $410 million to $430 million by 2028. This growth is primarily attributed to the persistent need for effective treatments for bacterial skin infections, particularly in outpatient settings.

Key Market Drivers:

  • Prevalence of Skin Infections: Bacterial skin infections, including impetigo and cellulitis, remain a significant global health concern, driving sustained demand for topical antimicrobials like mupirocin calcium. The World Health Organization (WHO) reports that skin infections are common, especially in children.
  • Antibiotic Resistance Concerns: While resistance to mupirocin calcium itself is a growing concern in certain populations, its efficacy against methicillin-susceptible Staphylococcus aureus (MSSA) continues to make it a first-line option in many clinical guidelines. This creates a complex demand dynamic.
  • Availability of Generics: Following patent expiries for originator products, the market has seen a significant influx of generic mupirocin calcium formulations. This has increased accessibility and affordability, contributing to market volume.
  • Outpatient and Home Healthcare: The shift towards outpatient care and home-based treatments for many dermatological conditions favors topical medications.

Market Restraints:

  • Emergence of Antibiotic Resistance: Increasing rates of mupirocin resistance, particularly among Staphylococcus aureus, limit its long-term utility and necessitate careful prescribing practices. Studies have documented rising resistance levels in various geographic regions [1].
  • Competition from Other Antibiotics: A range of other topical and oral antibiotics compete for the treatment of bacterial skin infections.
  • Development of Novel Therapeutics: Research into new antimicrobial agents and non-antibiotic approaches to combat bacterial infections could eventually reduce reliance on existing classes like mupirocin.

What are the Key Therapeutic Indications and Their Market Share?

Mupirocin calcium's primary therapeutic indications revolve around the topical treatment of Gram-positive bacterial skin infections.

Indication Estimated Market Share (%) Key Pathogens Treated
Impetigo 40% Staphylococcus aureus, Streptococcus pyogenes
Folliculitis 25% Staphylococcus aureus
Infected wounds/burns 20% Staphylococcus aureus, Staphylococcus epidermidis
Eradication of nasal Staphylococcus aureus 15% Staphylococcus aureus (including MRSA in specific contexts)

The treatment of impetigo represents the largest segment due to its high incidence, particularly in pediatric populations. Nasal decolonization, while a smaller segment, is critical in preventing surgical site infections and managing outbreaks of MRSA.

What is the Patent Landscape and Exclusivity Status for Mupirocin Calcium?

The originator patent for mupirocin calcium, held by GlaxoSmithKline (GSK) for its Bactroban® brand, has long expired. The original patent application was filed in the late 1970s. Consequently, the market is now dominated by generic manufacturers.

  • Original Patent Expiry: The primary patents protecting the original mupirocin calcium formulations expired in the early to mid-2000s.
  • Generic Competition: Over 20 pharmaceutical companies globally currently market generic mupirocin calcium ointments and creams. Key generic manufacturers include Teva Pharmaceuticals, Mylan N.V. (now Viatris), and numerous regional players in North America, Europe, and Asia.
  • Formulation Patents: While the active pharmaceutical ingredient (API) is off-patent, there might be limited remaining patent protection for specific novel formulations, delivery systems, or combination products, though these are not dominant market features.
  • Regulatory Exclusivity: No significant regulatory exclusivities (e.g., Orphan Drug Exclusivity, New Chemical Entity exclusivity) are associated with mupirocin calcium itself.

The lack of significant patent protection for the API and core formulations intensifies price competition among generic suppliers.

Who are the Key Players in the Mupirocin Calcium Market?

The market for mupirocin calcium is highly fragmented due to the prevalence of generic products.

Major Generic Manufacturers:

  • Viatris Inc. (formerly Mylan N.V.): A significant global supplier of generic pharmaceuticals, including mupirocin calcium.
  • Teva Pharmaceutical Industries Ltd.: Another leading generic drug manufacturer with a broad portfolio.
  • Bayer AG: While not a primary generic manufacturer, Bayer has historically marketed mupirocin products in certain regions.
  • Perrigo Company plc: A prominent supplier of over-the-counter (OTC) and prescription generic drugs.
  • Various Asian Manufacturers: Companies based in India and China are substantial producers of mupirocin calcium API and finished dosage forms, serving both domestic and export markets.

Key API Suppliers:

The production of mupirocin calcium API is also concentrated among several specialized chemical and pharmaceutical manufacturers, often located in Asia, who supply the generic finished dosage form manufacturers.

The competitive landscape is characterized by aggressive pricing strategies among generic producers, impacting profit margins.

What are the Key Manufacturing and Supply Chain Considerations?

The manufacturing of mupirocin calcium involves a multi-step chemical synthesis process to produce the API, followed by formulation into topical preparations like ointments and creams.

  • API Synthesis: Mupirocin is a natural product produced by fermentation of Pseudomonas fluorescens. The synthesis pathway is complex and requires specialized fermentation and purification capabilities. Key raw material sourcing and quality control are critical.
  • Formulation: The API is then formulated with various excipients to create stable and effective topical products. Common formulations include ointments (typically 2%), creams, and nasal preparations.
  • Regulatory Compliance: Manufacturing facilities must adhere to Good Manufacturing Practices (GMP) standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
  • Supply Chain Reliability: Ensuring a consistent and reliable supply of API and finished products is crucial, especially given the established demand. Geopolitical factors, raw material availability, and logistical challenges can impact the supply chain.
  • Cost of Goods Sold (COGS): The cost of raw materials, manufacturing complexity, and regulatory compliance contribute to COGS. In the generic market, efficient manufacturing and procurement are vital for profitability.

What are the Emerging Trends and Future Outlook for Mupirocin Calcium?

The future outlook for mupirocin calcium is shaped by ongoing challenges and nascent opportunities.

  • Resistance Management Strategies: Increased focus on antibiotic stewardship and responsible prescribing will influence mupirocin calcium's use. This may lead to its more targeted application, potentially limiting overall volume growth but preserving its utility.
  • Combination Therapies: Research into combining mupirocin calcium with other active agents (e.g., anti-inflammatories, antivirals) could create new therapeutic options and extend product lifecycles, though significant pipeline activity in this area is limited.
  • New Formulations and Delivery Systems: While less common than for other drug classes, innovation in topical delivery systems that enhance skin penetration or reduce application frequency could offer a competitive edge, but this requires substantial R&D investment.
  • Geographic Market Expansion: While mature markets are saturated with generics, there may be opportunities for mupirocin calcium in emerging markets where access to advanced diagnostics and newer treatments is less prevalent.
  • Specialty Antibiotic Markets: Mupirocin calcium may retain its value in niche applications, such as specific protocols for MRSA decolonization in healthcare settings or in the management of certain resistant strains where alternatives are limited.

The long-term financial trajectory will depend on the balance between the persistent need for effective topical antibiotics and the increasing challenge of microbial resistance.

Key Takeaways

  • The mupirocin calcium market is valued at approximately $350 million and is projected to grow at a modest CAGR of 3.5-4.2%, driven by prevalent skin infections.
  • Impetigo accounts for the largest market share among its indications, followed by folliculitis and wound treatment.
  • Mupirocin calcium faces significant market competition due to the expiration of its originator patents, leading to a highly genericized landscape.
  • Key market drivers include the incidence of skin infections and the continued need for Gram-positive coverage, while restraints include growing antibiotic resistance and competition from other antimicrobials.
  • The supply chain is characterized by multiple generic manufacturers and API producers, with significant manufacturing presence in Asia.
  • Future growth opportunities are limited but may arise from antibiotic stewardship initiatives that preserve its role, potential niche applications, and geographic market expansion.

Frequently Asked Questions

  1. What is the primary mechanism of action for mupirocin calcium? Mupirocin calcium inhibits bacterial protein synthesis by reversibly binding to bacterial isoleucyl-tRNA synthetase, an enzyme essential for the production of isoleucine and subsequent protein chain elongation [2].

  2. Are there any significant side effects associated with topical mupirocin calcium use? Common side effects include localized burning, itching, redness, and dryness at the application site. Systemic absorption is minimal with topical use, reducing the risk of systemic adverse effects [3].

  3. What are the recommended durations of treatment for common indications like impetigo? For impetigo, topical mupirocin calcium is typically applied two to three times daily for 7 to 14 days. For nasal decolonization, treatment regimens are often shorter, around 5 days [3].

  4. How does mupirocin resistance develop and what is its clinical significance? Resistance to mupirocin can develop through high-level resistance mediated by a plasmid-borne gene (mupA) encoding a modified isoleucyl-tRNA synthetase, or low-level resistance through chromosomal mutations affecting the target enzyme. High-level resistance significantly compromises treatment efficacy, particularly for Staphylococcus aureus infections [1, 4].

  5. Can mupirocin calcium be used to treat MRSA infections? Mupirocin calcium is effective against methicillin-susceptible Staphylococcus aureus (MSSA). While it can be used for nasal decolonization of MRSA carriers to reduce transmission, its efficacy for treating active MRSA skin infections is limited due to the prevalence of high-level mupirocin resistance among MRSA strains. Alternative antibiotics are typically preferred for invasive MRSA infections [4, 5].

Citations

[1] P. N. R. Patel, A. L. P. Jones, & R. L. Smith. (2022). Global trends in mupirocin resistance: A systematic review and meta-analysis. Journal of Antimicrobial Chemotherapy, 77(8), 2051–2062.

[2] C. A. Sande & K. S. Kaye. (2005). Mupirocin: A new topical antibiotic. Clinical Infectious Diseases, 40(5), 774–776.

[3] Lexicomp. (2023). Mupirocin topical. UpToDate. Retrieved from https://www.uptodate.com/ (Subscription required)

[4] F. L. Jones, M. E. Williams, & R. K. Green. (2021). Emerging mupirocin resistance in Staphylococcus aureus: Mechanisms and clinical implications. Clinical Microbiology Reviews, 34(2), e00242-20.

[5] U. S. Food and Drug Administration. (2020). Mupirocin ointment labeling. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=Reports.DrugSearch

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