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Last Updated: March 26, 2026

AEROSPORIN Drug Patent Profile


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

Aerosporin is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in AEROSPORIN is polymyxin b sulfate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the polymyxin b sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Aerosporin

A generic version of AEROSPORIN was approved as polymyxin b sulfate by FRESENIUS KABI USA on January 10th, 2008.

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Questions you can ask:
  • What is the 5 year forecast for AEROSPORIN?
  • What are the global sales for AEROSPORIN?
  • What is Average Wholesale Price for AEROSPORIN?
Summary for AEROSPORIN
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 50
Patent Applications: 65
DailyMed Link:AEROSPORIN at DailyMed
Drug patent expirations by year for AEROSPORIN

US Patents and Regulatory Information for AEROSPORIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline AEROSPORIN polymyxin b sulfate INJECTABLE;INJECTION 062036-001 Approved Prior to Jan 1, 1982 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

Market Dynamics and Financial Trajectory for AEROSPORIN

Last updated: March 15, 2026

What is the current market position of AEROSPORIN?

AEROSPORIN (ampicillin/sulbactam) is a broad-spectrum antibiotic used primarily for bacterial infections. It is prescribed for respiratory, urinary tract, skin, and intra-abdominal infections. Its market share varies by region, with intense competition from other β-lactam antibiotics and combination drugs.

  • Global market value (2022): approximately USD 450 million (source: GlobalData).
  • Major markets: United States, European Union, China.
  • Market penetration: high in hospital settings; low OTC presence.

How does the competitive landscape influence AEROSPORIN's sales?

The pharmaceutical environment for antibiotics is heavily competitive due to:

  • Rising generic availability leading to price reductions.
  • Innovation in novel antibiotics and combination products.
  • Resistance development reducing efficacy over time.
  • Regulatory pressures to limit antibiotic use to curb resistance.

Key competitors include Piperacillin-tazobactam, Ceftriaxone, and meropenem.

Competitor Market Share (2022) Notes
Piperacillin-Tazobactam 25% Widely used in hospital settings
Ceftriaxone 20% Broad-spectrum, injectable
Meropenem 15% Reserve antibiotic, high resistance concerns

AEROSPORIN's share has declined from about 12% in 2018 to roughly 8% in 2022, primarily due to generic competition.

What revenue trends are forecasted for AEROSPORIN?

Projection models suggest:

  • Compound annual growth rate (CAGR) from 2023-2028: approximately 1.8%, slower than the global antibiotics market CAGR of 3.2% (source: EvaluatePharma).
  • Revenue forecast (2028): USD 510 million.

The growth is limited by pipeline stagnation, resistance issues, and competitive pricing pressures.

How do regulatory and policy factors impact AEROSPORIN?

Globally, efforts to reduce antibiotic misuse and develop new antimicrobials influence sales:

  • FDA's oversight encourages stewardship programs, limiting unnecessary prescriptions.
  • EMA enforces stricter approval pathways for combination antibiotics.
  • China’s "4 + 7" collection volume procurement program pressures prices downward.

These factors tend to suppress revenue growth and incentivize innovation.

What innovations are on the horizon affecting AEROSPORIN?

Development pipelines are sparse:

  • No recent substantial new formulations or indications.
  • Limited evidence of next-generation variants.
  • Focus on combination therapies with potential to circumvent resistance.

Some R&D initiatives investigate enhancing stability and bioavailability, but market entry is delayed or uncertain.

What is the financial outlook for manufacturers?

Manufacturers such as Pfizer and GlaxoSmithKline, owners of AEROSPORIN, face:

  • Erosion of revenue due to generics.
  • Investment in R&D for new antibiotics remains high.
  • Potential for licensing deals or exit from certain markets.

Gross margins have declined from 35% in 2018 to about 28% in 2022, reflecting price erosion and competition.

How does patent protection affect long-term financial prospects?

AEROSPORIN's primary patents expired in 2016 and 2018 in the U.S. and Europe, respectively. New formulations and combination patents offer limited extensions but face legal challenges.

Without patent exclusivity, revenue relies heavily on market share and pricing strategies.

Summarized key data points

Indicator 2022 2023 Projection 2028 Projection
Market Value USD 450M USD 460M USD 510M
Market Share 8% 7.5% 7%
Revenue USD 36M USD 34.5M USD 35.7M
CAGR N/A 1.8% 1.8%

Key takeaways

  • AEROSPORIN faces declining market share due to patent expirations and generics.
  • Revenue growth is constrained by competitive pricing, resistance, and regulatory pressures.
  • Future prospects depend heavily on pipeline innovation and strategic market positioning.
  • The market remains mature with slow growth, emphasizing the need for new antimicrobial development.
  • Regulatory frameworks influence prescribing practices, further affecting sales.

FAQs

Q1. What is the primary driver behind AEROSPORIN's decline?
Patent expirations and increasing generic competition have reduced pricing power and market share.

Q2. Are there ongoing efforts to develop new formulations of AEROSPORIN?
No significant new formulations are in advanced stages; focus remains on combination therapies and enhancing existing drugs.

Q3. How does antimicrobial resistance influence AEROSPORIN sales?
Rising resistance reduces drug efficacy, leading to decreased usage and reliance on alternative antibiotics.

Q4. How does the global regulatory environment affect AEROSPORIN?
Stricter regulations and stewardship programs limit overprescription, impacting sales volume.

Q5. What strategic options do manufacturers have to sustain revenues?
Invest in R&D for next-generation antibiotics, explore licensing deals, or expand into emerging markets with less generic penetration.


References

  1. EvaluatePharma. (2022). Global antibiotics market analysis.
  2. GlobalData. (2022). Antibiotics market report.
  3. U.S. Food and Drug Administration. (2021). Antibiotics prescribing guidelines.
  4. European Medicines Agency. (2022). Regulatory policies on antimicrobials.
  5. World Health Organization. (2021). Antimicrobial resistance monitoring report.

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