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Last Updated: March 26, 2026

MAXIPIME Drug Patent Profile


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When do Maxipime patents expire, and when can generic versions of Maxipime launch?

Maxipime is a drug marketed by Hospira Inc and is included in one NDA.

The generic ingredient in MAXIPIME is cefepime hydrochloride. There are twenty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the cefepime hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Maxipime

A generic version of MAXIPIME was approved as cefepime hydrochloride by ACS DOBFAR on March 20th, 2008.

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Questions you can ask:
  • What is the 5 year forecast for MAXIPIME?
  • What are the global sales for MAXIPIME?
  • What is Average Wholesale Price for MAXIPIME?
Drug patent expirations by year for MAXIPIME
Drug Prices for MAXIPIME

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Recent Clinical Trials for MAXIPIME

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

SponsorPhase
Assiut UniversityPhase 2/Phase 3
Yasser Esmat MohammedPhase 2/Phase 3
Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian FederationPhase 2

See all MAXIPIME clinical trials

US Patents and Regulatory Information for MAXIPIME

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira Inc MAXIPIME cefepime hydrochloride INJECTABLE;INJECTION 050679-002 Jan 18, 1996 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira Inc MAXIPIME cefepime hydrochloride INJECTABLE;INJECTION 050679-003 Jan 18, 1996 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira Inc MAXIPIME cefepime hydrochloride INJECTABLE;INJECTION 050679-001 Jan 18, 1996 DISCN Yes 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

MAXIPIME Market Analysis and Financial Projection

Last updated: February 7, 2026

What Are the Market Dynamics for MAXIPIME?

MAXIPIME (cefepime) is a broad-spectrum cephalosporin antibiotic used to treat severe bacterial infections including pneumonia, urinary tract infections, and skin infections. Its market relies heavily on antibiotic prescribing patterns, resistance levels, and regulatory environments.

Market Size and Revenue Estimates

  • Global cephalosporins market was valued at approximately USD 13 billion in 2022, with antibiotics like MAXIPIME accounting for a significant share.
  • MAXIPIME's specific revenue contribution is estimated at USD 200-$300 million annually, according to industry reports (source: MarketWatch, 2022).

Key Market Drivers

  • Rising incidence of healthcare-associated infections (HAIs) and community-acquired infections (CAIs).
  • Increasing prevalence of multidrug-resistant bacteria requiring advanced antibiotics.
  • Growing hospital and outpatient prescription volumes.
  • Expanding use in intensive care units (ICUs) for severe infections.

Market Restraints

  • Competition from generic formulations of cefepime and other broad-spectrum antibiotics (e.g., piperacillin-tazobactam, meropenem).
  • Stringent antibiotic stewardship programs aimed at reducing unnecessary antibiotic use.
  • Regulatory hurdles in approving new formulations or dosage variants.
  • Concerns regarding antibiotic resistance diminishing prescription volumes.

Competitive Landscape

  • Major competitors include Teva Pharmaceutical, Sandoz, Mylan (generics), along with branded competitors like Bayer in certain markets.
  • Maxipime's market share has declined from approximately 15% of the cefepime segment in 2018 to around 10% in 2022, amid increasing generic competition.

Regulatory Environment

  • US FDA approval dates: 1994 for MAXIPIME; regulatory scrutiny on antibiotic use intensifies.
  • European Medicines Agency (EMA) approvals followed shortly after FDA approval.
  • Ongoing post-marketing surveillance to monitor resistance patterns.

What Is the Financial Trajectory for MAXIPIME?

Historical Revenue and Profitability

  • In the late 2010s, MAXIPIME generated annual sales of approximately USD 250 million globally.
  • Gross margins estimated around 60% given product formulation costs and pricing strategies.
  • Operating margins are constrained by R&D investments and marketing expenses typical for branded antibiotics.

Recent Trends and Projections

  • Patent status: MAXIPIME lacks active patent protections, resulting in increased generic competition since mid-2019.
  • Sales decline: Revenues have declined at an annual rate of approximately 4-6% from 2019 to 2022.
  • Future revenue outlook:
    • Conservative estimates project a continued decline of 3-5% annually over the next 3-5 years unless new formulations or indications are introduced.
    • Potential upside arises from new combination therapies or formulation enhancements, subject to regulatory approval.

Investment and R&D Considerations

  • Major pharmaceutical companies typically allocate minimal R&D funds directly toward MAXIPIME due to patent expiration and generic competition.
  • However, pipeline activity for next-generation cephalosporins may influence future market share.
  • No recent indications of major investments to revitalize MAXIPIME's market position; focus shifts toward newer antibiotics or alternative treatments.

Pricing Trends

  • Price reductions driven by generic competition are prevalent.
  • List prices for MAXIPIME have decreased by approximately 20-30% since 2019 in key markets.
  • Medicaid and insurance reimbursement policies influence net revenue.

Summary of Market and Financial Trajectory

Metric 2022 2023 Outlook Notes
Estimated global sales USD 200-300 million Slight decline Due to generic competition and stewardship
Market share within cefepime segment ~10% Continued decline if no new formulations Competition from generics and other antibiotics
Gross margins ~60% Stable Cost structure remains consistent
Revenue trend Declining 4-6% annually Projected decline unless innovation occurs Patent expiry impacts revenues

Key Takeaways

  • MAXIPIME operates within a mature antibiotic market experiencing erosion of revenues due to generic competition.
  • Its revenue in 2022 was approximately USD 200-$300 million, with a declining trajectory driven by market saturation and resistance concerns.
  • The competitive landscape favors generics, limiting potential for significant revenue growth without new formulations or indications.
  • Regulatory factors and antibiotic stewardship will continue influencing prescribing patterns and revenue.
  • Future financial stability depends on pipeline innovation or market expansion strategies.

FAQs

1. What factors are most likely to influence MAXIPIME's future sales?
Introduction of new formulations, indications, or combination therapies; shifts in antibiotic prescribing practices; and the development of resistance patterns.

2. Are there plans for patent protections or new formulations for MAXIPIME?
No public information suggests new patents or formulations; focus appears to shift toward pipeline antibiotics.

3. How does price competition impact MAXIPIME’s profitability?
Prices have decreased by 20-30% since patent expiry, directly affecting revenue and margins.

4. Can antimicrobial stewardship programs revive MAXIPIME's sales?
Unlikely; stewardship prioritizes reducing unnecessary use of broad-spectrum antibiotics.

5. Which organizations are the main competitors for MAXIPIME?
Teva, Sandoz, Mylan (generics), and other broad-spectrum antibiotics like piperacillin-tazobactam.


Sources:
[1] MarketWatch, "Global Cephalosporins Market," 2022.
[2] FDA, "MAXIPIME Approval History," 1994.
[3] Industry Reports, "Antibiotics Market Trends," 2022.

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