Last Updated: August 10, 2026

TIMENTIN Drug Patent Profile


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Summary for TIMENTIN
US Patents:0
Applicants:1
NDAs:3
Raw Ingredient (Bulk) Api Vendors: 31
Clinical Trials: 1
DailyMed Link:TIMENTIN at DailyMed
Recent Clinical Trials for TIMENTIN

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SponsorPhase
Osprey Medical, IncPhase 2

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US Patents and Regulatory Information for TIMENTIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Glaxosmithkline TIMENTIN clavulanate potassium; ticarcillin disodium INJECTABLE;INJECTION 050590-003 Aug 18, 1987 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TIMENTIN clavulanate potassium; ticarcillin disodium INJECTABLE;INJECTION 050590-002 Apr 1, 1985 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TIMENTIN clavulanate potassium; ticarcillin disodium INJECTABLE;INJECTION 062691-001 Dec 19, 1986 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Glaxosmithkline TIMENTIN clavulanate potassium; ticarcillin disodium INJECTABLE;INJECTION 050590-001 Apr 1, 1985 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
Last updated: July 10, 2026

TIMENTIN (ticarcillin + clavulanic acid): market dynamics and financial trajectory

TIMENTIN is the brand name for the fixed-dose combination antibiotic ticarcillin plus clavulanic acid. Its market trajectory is shaped by hospital-driven acute-care demand, payer pressure on broad-spectrum beta-lactam penetration, and competitive substitution by other ticarcillin/clavulanate brands and alternative IV beta-lactams. Financial performance is typically characterized by (1) cyclical utilization tied to inpatient admissions and resistant-organism incidence, (2) pricing compression after generic/bioequivalent erosion, and (3) limited lifecycle extension because the asset’s value is anchored to a mature molecule rather than a differentiated platform.

How big is the TIMENTIN market, and what drives hospital demand?

Short answer: The TIMENTIN market is primarily an inpatient hospital market for serious bacterial infections requiring IV therapy, with demand driven by antimicrobial stewardship protocols and formulary preference rather than outpatient prescribing.

Core demand drivers

  1. Inpatient infection burden: Higher admissions and ICU utilization lift IV antibiotic utilization.
  2. Stewardship and escalation pathways: Hospital antibiograms and sepsis pathways determine which broad-spectrum beta-lactams are preferred for empiric therapy.
  3. Resistant Gram-negative profiles: Ticarcillin/clavulanate use correlates with susceptibility patterns for beta-lactamase producing organisms.
  4. IV therapeutic interchange: Hospitals rotate among IV beta-lactams based on price, supply reliability, and shortage dynamics.

Pricing and volume dynamics

  • Volume: Typically stable at baseline due to persistent acute-care need, then fluctuates with seasonal infection patterns and hospital case-mix.
  • Net pricing: Compresses when competing products gain formulary share or when lower-priced equivalents enter the market.
  • Tendering: Public hospitals and group purchasing organizations can push down unit costs through batch procurement.

Where does TIMENTIN compete, and how do substitution dynamics affect sales?

Short answer: TIMENTIN competes in the IV broad-spectrum antibiotic class against other ticarcillin/clavulanate products and alternative beta-lactam regimens (including combinations with beta-lactamase inhibitors and carbapenems depending on hospital protocols).

Competitive set in practice

  • Direct class substitutes: Other ticarcillin/clavulanate brands and authorized generics.
  • Protocol substitutes: Piperacillin/tazobactam is a frequent comparator for empiric Gram-negative coverage.
  • Escalation substitutes: Carbapenems often replace broader beta-lactams for severe resistance scenarios, particularly where stewardship restricts use of certain agents.

Formulary and switching

  • Hospitals minimize antibiotic expenditure by standardizing to preferred procurement SKUs.
  • Switching occurs when price, supply assurance, and allergy or stability constraints favor an alternative product.
  • Contract renewals at the GPO or hospital group level can produce step-change volume shifts.

What is the financial trajectory for TIMENTIN over time (launch to today)?

Short answer: For mature IV antibiotic brands, the financial trajectory typically trends from prescription growth at launch to peak utilization and then to gradual erosion through generic competition and procurement-driven pricing compression. The steepness depends on the strength and timing of exclusivity and the intensity of branded competition.

Typical lifecycle pattern for mature fixed-dose antibiotic brands

  • Peak phase: Brand adoption in tertiary hospitals; uptake in empiric protocols.
  • Compression phase: Entry of equivalent products and increased tender competition.
  • Late lifecycle: Continued volume presence but shrinking revenue per dose; reliance on institutional relationships and supply continuity.

Revenue mechanics

Revenue generally equals unit sales times net price, where:

  • Unit sales are anchored in IV antibiotic treatment protocols.
  • Net price declines as procurement shifts to cheaper alternatives.
  • Gross-to-net erosion increases as payer contracting and rebates tighten.

How do patent and exclusivity timelines shape TIMENTIN’s revenue ceiling?

Short answer: TIMENTIN’s financial ceiling is determined by the point at which equivalents can legally launch and by the availability of multiple competing SKUs in hospital tenders.

Exclusivity and IP impacts (mechanism)

  1. Primary composition and process patents: Can delay direct generic competition where still in-force.
  2. Formulation and packaging patents: Can delay specific presentations (strengths, containers, reconstitution formats).
  3. Regulatory exclusivities: Can add limited time if tied to specific data packages, though for a mature antibiotic the main impact is usually from patent-driven entry rather than long exclusivity monopolies.

What is the Orange Book status of TIMENTIN, and what does it imply for generic entry risk?

Short answer: TIMENTIN is a legacy combination product; its U.S. competitive risk typically maps to the presence of FDA-approved “same active ingredient” equivalents and the availability of ANDA products for those strengths.

How Orange Book status translates to commercial risk

  • If multiple ANDAs list the same strength and route, price competition typically becomes structural.
  • If only limited strengths are available generically, revenue protection persists by presentation-level constraints.
  • If there are delayed entrants due to patent litigation, the market may show temporary pricing resilience followed by a step down at settlement or final court outcomes.

What patent estate typically protects a ticarcillin/clavulanate combination product like TIMENTIN?

Short answer: The patent estate usually concentrates around drug product compositions, manufacturing methods, and stability-related formulation parameters rather than novel mechanisms.

Common IP buckets for fixed-dose antibiotics

  • Drug substance and salt/process claims
  • Combination ratio and fixed-dose formulation claims
  • Manufacturing process claims (mixing order, granulation, sterilization or filtration steps depending on dosage form)
  • Stability and shelf-life claims tied to container closure and storage conditions
  • Packaging and reconstitution claims for IV preparations

Which companies sell competing ticarcillin/clavulanate products that pressure TIMENTIN net price?

Short answer: Competition is usually dominated by generic manufacturers and other brand owners with manufacturing capacity aligned to hospital demand and tender cycles.

Commercial competition pattern

  • Multiple authorized generics in key strengths drive a “lowest net price” procurement outcome.
  • Brand owners compete through negotiated hospital rebates and supply assurance, which can narrow margins without sustaining unit volume.

What does hospital procurement do to TIMENTIN margins and cash conversion?

Short answer: Procurement-driven pricing compression is the primary driver of margin decline; cash conversion is typically supported by institutional purchasing cycles.

Margin pressure channels

  • Price compression after equivalent entry
  • Increased promotional and contract support to defend formulary status
  • Higher freight and distribution costs relative to unit price
  • Waste risk due to vial/kit-based hospital storage practices and expiration management

Working capital

  • Institutional buyers often pay via net terms, sustaining predictable receivables cycles.
  • Inventory management is critical around supply shortages and expiration windows.

How does antimicrobial stewardship influence TIMENTIN volume trajectory?

Short answer: Stewardship can both reduce overall beta-lactam utilization through restriction and maintain use by designating specific agents for particular infection phenotypes.

Stewardship levers

  • “Restricted use” protocols that require justification for broad-spectrum IV antibiotics
  • De-escalation pathways that shift therapy after culture results
  • Local susceptibility thresholds that determine agent preference

What generic entry scenarios are most likely to impact TIMENTIN?

Short answer: The highest-impact scenario is broad ANDA availability across core strengths leading to stepwise net price declines and substitution in hospital tenders.

Most common outcome profiles

  1. Strength-by-strength erosion: Each strength loses share when its equivalent enters.
  2. Contract-driven reallocation: Even if an equivalent is approved, volume migrates only at contract renewal or tender rebid.
  3. Temporary resilience via supply reliability: Brand or higher-reliability equivalents retain share until supply stabilizes.

When does TIMENTIN lose exclusivity in practice, and how fast does uptake shift?

Short answer: Practical exclusivity loss occurs when competitors gain the ability to market equivalent product for the same presentations and hospitals operationalize procurement switching. Uptake is often fast once contracts expire and stocking changes occur.

Timing mechanics

  • IP or regulatory barriers removed
  • First generic shipment availability
  • Pharmacy and therapeutics committee review
  • Tender rebid and formulary updates
  • Nursing and pharmacy workflow integration

How do safety and formulation stability affect the commercial trajectory of TIMENTIN?

Short answer: In mature IV antibiotics, safety and stability mainly affect substitution decisions through handling characteristics, shelf-life, and compatibility requirements.

Operational determinants

  • Container closure and shelf-life reliability
  • Preparation and reconstitution workflow compatibility
  • Compatibility with IV lines and co-administered solutions
  • Storage requirements and expiration lot management

What are the main financial risks to TIMENTIN in the current market?

Short answer: Net price compression, supply variability across competitors, and shifts in preferred empiric regimens toward alternative beta-lactams or carbapenem-sparing strategies.

Risk list

  • Higher reimbursement pressure and stricter procurement cost controls
  • Increased competition from piperacillin/tazobactam and other beta-lactam/beta-lactamase inhibitor options
  • Shortage cycles that distort demand and force temporary substitution
  • Stewardship restrictions that limit use for low-susceptibility infection categories

Key takeaways

  • TIMENTIN’s market is driven by hospital inpatient utilization, stewardship protocols, and procurement cycles.
  • Financial trajectory follows the typical mature IV antibiotic pattern: stable baseline volume with structural net price erosion as equivalents expand.
  • The dominant economic variable is not therapeutic differentiation but substitution and contract switching across equivalent strengths and routes.
  • Patent and exclusivity timing primarily sets the “entry date,” while procurement implementation sets the “revenue step-down timing.”

FAQs

Does TIMENTIN sell more in ICU settings than general wards?

Yes in most formularies, because IV empiric and severe infection protocols concentrate utilization in ICU and acute care service lines.

How does a shortage of competing beta-lactams change TIMENTIN demand?

Demand can increase temporarily when preferred alternatives are constrained and hospitals switch to available IV options.

What infection types drive the most TIMENTIN prescribing?

Serious bacterial infections where Gram-negative coverage and beta-lactamase inhibition are clinically indicated under hospital empiric or targeted therapy pathways.

Do hospitals switch from TIMENTIN to piperacillin/tazobactam often?

Switching can be frequent where antibiograms support it and where procurement favors piperacillin/tazobactam on net price and contract terms.

What presentation-level changes affect TIMENTIN competitiveness?

Strength availability, packaging format, and shelf-life logistics influence stocking decisions and determine whether equivalents take share at the tender level.

References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-10).
  2. FDA. Drug Approval Packages: Information for Prescription Drug Products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-10).

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