Last Updated: June 30, 2026

BICILLIN Drug Patent Profile


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Summary for BICILLIN
Recent Clinical Trials for BICILLIN

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SponsorPhase
Washington University School of MedicinePHASE3
University of TennesseePhase 2
National Institute of Allergy and Infectious Diseases (NIAID)Phase 3

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US Patents and Regulatory Information for BICILLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Wyeth Ayerst BICILLIN penicillin g benzathine SUSPENSION;ORAL 050126-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms Llc BICILLIN L-A penicillin g benzathine INJECTABLE;INJECTION 050141-001 Approved Prior to Jan 1, 1982 BC RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
King Pharms Llc BICILLIN C-R penicillin g benzathine; penicillin g procaine INJECTABLE;INJECTION 050138-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst BICILLIN L-A penicillin g benzathine INJECTABLE;INJECTION 050131-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst BICILLIN penicillin g benzathine TABLET;ORAL 050128-001 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

BICILLIN (penicillin G benzathine) market dynamics and financial trajectory: revenues, pricing pressure, supply risk, and exclusivity-driven outlook

Last updated: June 23, 2026

Executive summary

Bicillín is a legacy penicillin product line (penicillin G benzathine) with recurring demand tied to streptococcal disease prevention and treatment in outpatient settings, obstetrics where indicated, and select institutional protocols. The financial trajectory is dominated by (1) pricing declines from generic competition and channel mix, (2) periodic supply disruptions that move units and pricing quickly, and (3) regulatory and manufacturing constraints typical of long-acting injectable penicillins. Contracting and reimbursement dynamics determine near-term revenue more than label expansion, since patent-led defensibility is largely exhausted for the underlying active ingredient. The market is best modeled as a mature, low-to-mid growth commodity with episodic volatility driven by supply availability and procurement pricing rather than innovation cycles.

What is Bicillin (penicillin G benzathine) and where does it sell?

Bicillin is a brand name used for long-acting benzathine penicillin G, typically supplied as an intramuscular injectable suspension. It is used for susceptible infections where prolonged exposure is clinically relevant, including prevention and treatment workflows for streptococcal syndromes. Commercial positioning depends on geography, contracting, and tender cycles because the product competes primarily with other benzathine penicillin products that are therapeutically equivalent.

Which indications drive volume and repeat demand?

Volume tends to track:

  • Pediatric and adult outpatient treatment pathways that require a one-dose or infrequent dosing regimen
  • Institutional protocols for streptococcal disease management
  • Cold-chain- or storage-compatible procurement decisions for intramuscular depot antibiotics

How do procurement and reimbursement affect revenue?

Revenue is shaped by:

  • Pharmacy benefit and medical benefit contracting mix for administered injectables
  • Hospital group purchasing organization (GPO) and wholesaler pricing
  • Payer policies that steer toward lowest net cost therapeutically equivalent products

What substitutes compete with Bicillin?

Substitution risk typically comes from other benzathine penicillin G brands and generics, plus alternative antibiotic classes where clinically acceptable. Since the molecule is long-established, differentiation is usually about availability and net pricing rather than clinical superiority.

Why do Bicillin prices and volumes fluctuate?

Bicillin’s unit economics are sensitive to supply and working-capital constraints because sterile injectables with long-acting formulations can face manufacturing bottlenecks. When supply tightens, list prices and net pricing can rise even in mature markets; when supply normalizes, price compression returns.

What supply-chain factors matter most?

Key swing factors:

  • Sterile manufacturing capacity and batch release timing
  • Raw material availability for penicillin intermediates and fermentation inputs
  • Filtered suspension fill-finish throughput for intramuscular depots
  • Regulatory lot disposition and stability constraints that reduce effective supply

How does inventory behavior shift financial performance?

  • Hospitals and wholesalers increase safety stock when shortages appear, lifting orders ahead of clinic demand.
  • When supply normalizes, pull-through weakens and net pricing discounts return, compressing revenue.

How does generic competition shape Bicillin’s financial trajectory?

For legacy penicillin formulations, financial trajectory is usually characterized by:

  • Early brand revenue plateau followed by step-down after generic penetration
  • Continued erosion from multiple competitors and private-label or repackaged equivalents
  • Reduced pricing power over time

What does “brand vs. generic” mean in practice for Bicillin?

Even when brand names persist in formularies, the payor contract often anchors net pricing to lowest-cost therapeutically equivalent offerings. The result is a market where revenue can remain steady in units but declines in value, unless supply shortages enable temporary price increases.

What is the typical margin profile?

Margins tend to compress because:

  • Competition pressures gross-to-net pricing
  • Manufacturing costs remain relatively fixed while utilization can swing with availability
  • Sales rely more on contracting and distribution than on specialty premium pricing

What revenue exposure does Bicillin have to reimbursement and payer policy?

Bicillin’s commercial outcome is tied to whether payers treat the product as a preferred antibiotic within injectable procurement rules and whether administration billing is bundled or reimbursed under medical benefit policies.

How do policy changes show up in financials?

  • Formulary shifts can move share across brands and generics
  • Prior authorization and step edits in certain plans can redirect to alternatives
  • Non-preferred status typically reduces share if lower net-cost alternatives are available

When does Bicillin lose exclusivity, and how does that affect market share?

For penicillin G benzathine, exclusivity is largely not a growth lever for long horizons. The value proposition after the primary innovation window is constrained by generic market entry and biosimilar-style replacement dynamics do not apply because the product is a small molecule.

Does Bicillin still have meaningful patent-led exclusivity?

Practically, the market is governed more by manufacturing and generic competition than by active exclusivity. Any remaining formulation or method-of-use protection, if present, would be less visible in consumer-facing financials than contracting-driven share shifts.

What should be expected after exclusivity ends?

  • Rapid share shift toward lowest net cost benzathine penicillin G offerings
  • Revenue value erosion, with unit persistence depending on clinical inertia and procurement cycles
  • Increased volatility during supply constraints as competitors compete for the same administered demand

What FDA status and Orange Book dynamics apply to Bicillin?

Bicillin is an FDA-approved antibiotic product with an Orange Book record for the listed drug product(s). Financial and competitive positioning typically follows:

  • Whether additional applicants are listed for same active ingredient and dosage form
  • Patent list coverage, if any, and whether listed patents are actively litigated or have expired
  • Whether there are recent label changes that shift formulations or strengths

What Orange Book factors drive competitive entry risk?

  • Number of listed patents tied to the dosage form
  • Patent expiration cadence and whether remaining patents are method-of-use or formulation rather than composition
  • Any regulatory amendments that narrow or expand covered product configurations

What Paragraph IV challenges and litigation risks exist for Bicillin?

For legacy penicillin products, the litigation landscape is usually less active than for modern biologics and high-revenue small molecules. Where challenges occur, they often relate to:

  • Patent listed in the Orange Book
  • Formulation or manufacturing methods tied to specific drug product presentations

How do settlements typically affect financial outcomes?

Where settlements exist, they typically:

  • Delay generic entry for a defined period
  • Create a time-bounded share and pricing protection window
  • Shift competitive pressure forward into post-settlement periods

What manufacturing and IP barriers can delay generic substitution?

For sterile depot injectables, barriers that can slow substitution include:

  • Limited fill-finish capacity for the specific vial presentation and strength
  • Stability requirements that can limit alternative manufacturing sites
  • Quality system constraints and batch rejection risk that reduce effective supply

How does “effective supply” impact cash flow?

When effective supply tightens, buyers accept non-preferred options that meet availability needs. This can temporarily sustain revenue value even in a generic-heavy market, but it is transient and supply-dependent.

How does Bicillin compare with other benzathine penicillin G products?

Commercial competition is mostly within the benzathine penicillin G class, where differences are:

  • Brand vs. generic pricing and distribution reach
  • Presentation details (strengths, vial size, packaging configurations)
  • Availability and allocation policies during shortages

Which competitive levers determine share?

  • Net price and rebates under GPO and wholesaler contracts
  • Reliability of supply (fewer stock-outs)
  • Distribution coverage and ability to fulfill tender contracts

What is the commercial trajectory under a “normal supply” scenario?

Under normalized supply:

  • Revenue value trends downward due to pricing pressure and generic share gains
  • Unit volumes stabilize or grow modestly with population and prescribing patterns
  • Promotional intensity is limited, with procurement decisions the main driver

What is the commercial trajectory under a “short supply” scenario?

Under shortages:

  • Net prices can rise and revenue value can rebound quickly
  • Buyers may increase orders ahead of administered demand
  • Cash conversion can improve for suppliers with supply allocation leverage, while competitors may experience missed sales

What growth drivers could extend Bicillin’s financial life?

Because Bicillin is a mature antibiotic, growth drivers are incremental:

  • Institutional protocol updates that reinforce injectable depot penicillin use
  • Payer contracting that favors reliable supply providers
  • Improved manufacturing capacity by incumbent or major generic entrants

Key metrics to monitor for Bicillin’s financial trajectory

For a company portfolio view, track:

  • Prescription/administered volume proxies from pharmacy and medical claims (where available)
  • Wholesale inventory and order rates during tender cycles and shortage alerts
  • Net pricing versus list price trends by quarter
  • Market share shifts among benzathine penicillin G brands and generic equivalents
  • Manufacturing capacity utilization and batch release schedules for key sites

Key Takeaways

  • Bicillin’s financial trajectory is driven mainly by mature-market pricing compression and the supply reliability of sterile long-acting penicillin G products.
  • Exclusivity is not a sustained revenue growth lever for long horizons; contracting and generic competition dominate.
  • Revenue value can swing materially during supply constraints, even when underlying demand is stable.
  • The competitive battleground is dependable fulfillment and net price in procurement cycles, not innovation-led differentiation.

FAQs

1. What are the main sales channels for Bicillin in the US (outpatient vs hospital)?
2. How do benzathine penicillin G shortages typically affect Bicillin net pricing and unit orders?
3. What factors determine formulary preference among competing benzathine penicillin G products?
4. Which procurement and GPO mechanisms most influence Bicillin contract pricing?
5. How can manufacturing batch release delays translate into quarter-to-quarter revenue swings for Bicillin?

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/
  2. FDA. Drug Shortages. U.S. Food and Drug Administration. https://www.fda.gov/drugs/drug-shortages

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