Last Updated: May 11, 2026

AMPICILLIN AND SULBACTAM Drug Patent Profile


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When do Ampicillin And Sulbactam patents expire, and when can generic versions of Ampicillin And Sulbactam launch?

Ampicillin And Sulbactam is a drug marketed by Acs Dobfar, Antibiotice, Astral, Eugia Pharma Speclts, Eurofarma, Hikma, Hospira Inc, Hq Speclt Pharma, Istituto Bio Ita Spa, Onesource Specialty, and Sandoz. and is included in twenty-three NDAs.

The generic ingredient in AMPICILLIN AND SULBACTAM is ampicillin sodium; sulbactam sodium. There are seventy drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the ampicillin sodium; sulbactam sodium profile page.

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Summary for AMPICILLIN AND SULBACTAM
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Pharmacology for AMPICILLIN AND SULBACTAM

US Patents and Regulatory Information for AMPICILLIN AND SULBACTAM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Onesource Specialty AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 202197-001 Apr 7, 2014 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Istituto Bio Ita Spa AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065222-002 Nov 29, 2005 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Sandoz AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065241-001 Jul 25, 2006 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Istituto Bio Ita Spa AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065314-001 Nov 27, 2006 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Acs Dobfar AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065406-001 Dec 22, 2009 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hikma AMPICILLIN AND SULBACTAM ampicillin sodium; sulbactam sodium INJECTABLE;INJECTION 065076-001 Mar 19, 2002 AP RX 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

AMPICILLIN AND SULBACTAM: Market Dynamics and Financial Trajectory

Last updated: April 26, 2026

Ampicillin and sulbactam is a mature, off-patent antibiotic combination with sustained institutional demand, limited price upside, and revenue concentrated in inpatient and emergency-care formularies. Market growth is driven less by innovation and more by hospital procurement cycles, generic substitution, and regional mix across acute-care utilization and antimicrobial stewardship policies. Financial trajectory is typically characterized by steady but pressured unit economics: volume can remain stable or grow modestly, while pricing and margin compress under multi-source competition.

What is the market structure for ampicillin and sulbactam?

Is it branded, generic, or both?

Ampicillin/sulbactam is predominantly supplied as generics and multi-source brands in most markets where it is marketed. The combination is widely used as an injectable beta-lactam/beta-lactamase inhibitor for susceptible infections, which supports consistent demand.

How does the procurement model shape demand?

Demand skews institutional:

  • Hospitals and large integrated delivery networks place the bulk of orders.
  • Formularies and therapeutic interchange protocols largely determine share.
  • Tendering and price benchmarking drive periodic price resets.
  • Stewardship policies can limit overuse but do not eliminate need for guideline-concordant patients.

What does that imply for share dynamics?

In mature antibiotic combinations, share is less about clinical differentiation and more about:

  • Contract pricing and supply reliability
  • Compliance with procurement specifications (presentation, vial size, reconstitution profile)
  • Distribution channel access (hospital group purchasing organizations, wholesalers, distributor contracts)

What are the main market demand drivers?

Which infection categories sustain use?

Real-world use is typically anchored in acute bacterial infections where clinicians select beta-lactam/beta-lactamase inhibitor coverage. Common institutional use cases include:

  • Intra-abdominal and intra-pelvic infections (susceptible organisms)
  • Skin and soft tissue infections where beta-lactamase activity is a concern
  • Empiric inpatient treatment in settings with local susceptibility patterns
  • Off-guideline use can occur but is constrained in many systems by antimicrobial stewardship

How do antimicrobial stewardship and resistance trends affect sales?

Stewardship generally:

  • Pressures use volume for non-indicated patients
  • Shifts prescribing toward narrower-spectrum options where possible
  • Increases documentation requirements for empiric therapy

Resistance trends do not remove the category, but they change:

  • Which patients receive the product
  • Whether the product is used as empiric first-line versus later-line therapy

Does guideline inclusion drive volume?

Where ampicillin/sulbactam appears in local antimicrobial formularies and clinical pathways, it anchors recurring procurement. If pathways migrate to alternatives, volume can decline without a commensurate offset from new indications.

What are the key constraints on pricing?

Does multi-source competition cap pricing power

Yes. For off-patent combinations, competitive equilibrium typically limits:

  • List price increases
  • Margin expansion
  • Premium pricing for “same molecule” generics

Competitive intensity increases when:

  • Multiple manufacturers can supply comparable strengths and package formats
  • National or regional tendering rewards lowest acquisition cost
  • Switching becomes operationally simple for hospitals

How does supply and manufacturing footprint affect pricing?

Pricing can improve temporarily in the event of:

  • Manufacturing outages or capacity disruptions
  • Regulatory actions (product withdrawals) in specific regions
  • Lead-time constraints that reduce immediate substitution

However, these effects are usually episodic and revert once supply normalizes.

How has the financial trajectory typically evolved for this class?

What does “financial trajectory” look like for mature injectable antibiotics?

For ampicillin/sulbactam, the class pattern is:

  • Revenue stability from institutional baseline demand
  • Gradual declines or flat growth in many developed markets due to price compression
  • Growth in emerging markets where hospitalization rates and procurement scale rise
  • Margin pressure linked to generic competition and contract pricing

What is the typical impact on revenue vs. profitability?

  • Revenue: tends to track utilization more than pricing.
  • Gross margin: tends to compress because the product is substitutable and frequently tender-priced.
  • Operating profit: depends on scale, procurement costs, and manufacturing efficiency.

What is the investment and business implication for manufacturers?

Where can players defend revenue?

The highest defensibility usually comes from execution rather than chemistry:

  • Securing major hospital contracts and staying preferred within therapeutic interchange frameworks
  • Ensuring uninterrupted supply and acceptable distribution terms
  • Offering stable presentation formats that match procurement specs
  • Managing compliance and quality consistency to avoid tender disqualification

What is the main risk to financial performance?

  • Further price erosion due to additional entrants or aggressive tender outcomes
  • Switching to alternative beta-lactam/beta-lactamase inhibitor products
  • Contract re-tendering that resets acquisition cost
  • Regulatory or quality events that reduce marketability or market access

How do product form factors influence sales outcomes?

Does injection format matter?

For hospital antibiotics, form factor impacts:

  • Pharmacy handling and workflow
  • Inventory management (vial sizes, packaging)
  • Compatibility with administration protocols

Even when molecules are the same, hospitals may prefer specific presentations due to:

  • Reduced wastage
  • Easier reconstitution
  • Alignment with existing preparation equipment and protocols

Market dynamics by region: how does mix change?

Developed markets

Common dynamics:

  • Strong generic competition
  • Tendering and centralized procurement drive price compression
  • Stewardship limits non-indicated prescribing but preserves guideline use

Emerging markets

Common dynamics:

  • Higher growth potential from increased access to inpatient care
  • Procurement scale and government or payer programs can expand volume
  • Price pressure still exists, but volume expansion can offset pricing declines

Competitive landscape: what determines the winner?

What is the competitive “unit of measure”?

For this product, unit economics are shaped by:

  • Contract price per dose and effective acquisition cost
  • Availability and delivery reliability
  • Hospital formulary and therapeutic substitution rules

Do clinical differentiators drive share?

Generally, no. With mature antibiotic combinations, switching is usually cost and logistics-driven unless:

  • A competitor has supply advantage
  • A formulation has specific handling advantages
  • Local resistance shifts favor alternative agents

Financial outlook: base case trajectory

What is the base case for sales growth?

Base case is typically:

  • Flat to modest growth in volume driven by acute-care demand and ongoing inpatient antibiotic protocols
  • Ongoing price pressure due to multi-source competition

What is the base case for profitability?

Base case is typically:

  • Margin compression or stable margins dependent on manufacturing cost control
  • Higher sensitivity to raw material costs, yield, and batch efficiency
  • Profit variability linked to contract timing and manufacturing utilization

Key Takeaways

  • Ampicillin and sulbactam is a mature, off-patent injectable combination with demand dominated by institutional procurement rather than product-level innovation.
  • Market growth is constrained by generic substitution and tender-driven pricing, so revenue typically tracks utilization more than price.
  • Financial trajectory usually shows stable or modest volume growth with margin pressure from multi-source competition and periodic contract re-pricing.
  • Business outcomes depend on contracting execution, supply reliability, and presentation compatibility with hospital pharmacy workflows.

FAQs

  1. Is ampicillin and sulbactam mainly sold as a generic?
    Yes. In most markets the combination is predominantly supplied by generics and multi-source brands, with pricing set largely through competition and tendering.

  2. What drives hospital purchasing decisions for this antibiotic combination?
    Contract acquisition cost, availability, alignment with formulary and interchange rules, and pharmacy handling requirements for the specific injection presentation.

  3. How does antimicrobial stewardship affect the product’s revenue?
    Stewardship reduces inappropriate use but does not eliminate demand when the product matches guideline-concordant empiric or targeted use in susceptible infections.

  4. Does resistance meaningfully reduce category demand?
    Resistance shifts which patients are treated and whether the drug is used empirically, but it rarely removes the category entirely in mature markets.

  5. What is the biggest financial risk for manufacturers?
    Further price erosion from additional entrants or aggressive tender outcomes, compounded by margin sensitivity to manufacturing efficiency and supply disruptions.

References

[1] CDC. Antibiotic Use and Stewardship. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/ (accessed 2026-04-26).
[2] WHO. Antimicrobial Resistance and Containment. World Health Organization. https://www.who.int/health-topics/antimicrobial-resistance (accessed 2026-04-26).
[3] FDA. Guidance for Industry: Hospital Antimicrobial Stewardship Programs. U.S. Food and Drug Administration. https://www.fda.gov/ (accessed 2026-04-26).
[4] EMA. Antimicrobial resistance and stewardship related materials. European Medicines Agency. https://www.ema.europa.eu/ (accessed 2026-04-26).

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