Last Updated: May 10, 2026

ERYTHROMYCIN STEARATE - Generic Drug Details


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What are the generic drug sources for erythromycin stearate and what is the scope of freedom to operate?

Erythromycin stearate is the generic ingredient in eight branded drugs marketed by Bristol, Parke Davis, Warner Chilcott, Azurity, Ani Pharms, Lederle, Pharmobedient, Purepac Pharm, Watson Labs, Bristol Myers Squibb, Pfizer, and Wyeth Ayerst, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for erythromycin stearate.

Summary for ERYTHROMYCIN STEARATE
US Patents:0
Tradenames:8
Applicants:12
NDAs:15
Drug Master File Entries: 18
Raw Ingredient (Bulk) Api Vendors: 128
Clinical Trials: 1
Drug Prices: Drug price trends for ERYTHROMYCIN STEARATE
What excipients (inactive ingredients) are in ERYTHROMYCIN STEARATE?ERYTHROMYCIN STEARATE excipients list
DailyMed Link:ERYTHROMYCIN STEARATE at DailyMed
Drug Prices for ERYTHROMYCIN STEARATE

See drug prices for ERYTHROMYCIN STEARATE

Recent Clinical Trials for ERYTHROMYCIN STEARATE

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

SponsorPhase
Chr Hansen A/SN/A
Chr HansenN/A
Ryerson UniversityN/A

See all ERYTHROMYCIN STEARATE clinical trials

US Patents and Regulatory Information for ERYTHROMYCIN STEARATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms ERYTHROMYCIN STEARATE erythromycin stearate TABLET;ORAL 063179-001 May 15, 1990 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer PFIZER-E erythromycin stearate TABLET;ORAL 061791-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pfizer PFIZER-E erythromycin stearate TABLET;ORAL 061791-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Wyeth Ayerst WYAMYCIN S erythromycin stearate TABLET;ORAL 061675-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bristol Myers Squibb ETHRIL 250 erythromycin stearate TABLET;ORAL 061605-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Pharmobedient ERYTHROMYCIN STEARATE erythromycin stearate TABLET;ORAL 061505-001 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

ERYTHROMYCIN STEARATE Market Analysis and Financial Projection

Last updated: April 23, 2026

Market Dynamics and Financial Trajectory for Erythromycin Stearate

What is the market structure for erythromycin stearate?

Erythromycin stearate is a long-established oral macrolide antibacterial positioned in the broader “erythromycin” and “macrolides” therapeutic class. Demand dynamics track four variables: (1) incidence of bacterial infections treatable by macrolides, (2) prescribing preferences versus newer oral agents, (3) antibiotic resistance and guideline pressure, and (4) generic competition.

Key structural attributes

  • Generic-led market: Erythromycin stearate is widely available as an established product. Pricing power typically sits with low-cost manufacturing and scale, not differentiation.
  • Inelastic end use, elastic pricing: When antibiotic selection shifts, volume can move, but switching between equivalent formulations (same active, compatible strength) usually happens quickly at the pharmacy level.
  • Regulatory and supply sensitivity: Antibiotics rely on reliable API and excipient sourcing; batch disruptions can swing near-term availability and pricing.
  • Formulation tradeoffs: Erythromycin base, erythromycin ethylsuccinate, and erythromycin estolate compete where tolerability, GI profile, and dosing convenience drive selection. Erythromycin stearate is a branded/generic historical option in oral therapy.

How do clinical and guideline forces shape demand?

Erythromycin is constrained by (1) macrolide resistance trends and (2) guideline shifts that prioritize other agents for common indications. In practice, this compresses both new patient share and pricing over time, especially once multiple generics compete.

Demand shapers by therapy pattern

  • Community respiratory infections: Macrolides face substitution by other oral antibiotics when resistance or safety profiles drive guideline changes.
  • Pediatric and dental indications: Macrolides can retain usage, but utilization increasingly depends on localized resistance patterns and clinician preference.
  • Prophylaxis and niche indications: Some historical uses persist, but market growth typically comes from sustaining volume rather than expanding indications.

What are the economics of an established generic antibiotic like erythromycin stearate?

For older, off-patent antibiotic products, the financial trajectory is usually defined by:

  • falling ASPs under generic competition,
  • margin compression due to increased price transparency,
  • and survival of supply-chain efficiency and manufacturing reliability.

Typical financial mechanics

  • Pricing: Downward pressure from multi-source availability and procurement frameworks.
  • Gross margin: Sensitive to API costs and manufacturing yields; steady-state profitability depends on scale and contract manufacturing alternatives.
  • Working capital: Oral solid dose products often have predictable turns, but inventory misalignment can cost quickly when price resets occur.
  • Volume: More stable than price, but still cyclical with seasonal infection patterns and prescribing cycles.

How do market dynamics differ across channels and geographies?

Erythromycin stearate distribution often splits across:

  • Hospital and institutional purchasing (tender-driven; price is dominant),
  • Retail pharmacy (brand recognition can matter less than formulary positioning),
  • Direct-to-wholesaler channels that respond to availability and price.

Channel implications

  • Institutional: Tenders reset pricing quickly; suppliers win via cost and supply assurance.
  • Retail: Substitution rules and prescribing habits move demand at the script level; once a low-cost generic dominates, share concentrates.
  • Regulatory-driven procurement: Any tightening of antibiotic stewardship in hospital formularies can reduce utilization, even if community demand holds.

What is the likely financial trajectory (revenue, margin, cash flow) for erythromycin stearate?

Given the product’s established status and generic nature, the expected financial trajectory follows a mature lifecycle curve:

Revenue

  • Flat to declining nominal revenue driven by pricing resets.
  • Stable to modestly variable units depending on seasonal infection volume and local prescribing patterns.
  • Share concentration toward lowest-cost, reliably supplied SKUs (strength-specific).

Margins

  • Gross margin compression across the cycle due to generic competition and procurement-driven price pressure.
  • Stabilization only where the manufacturer sustains low COGS (API procurement, manufacturing efficiency, yields).

Cash flow

  • Near-term cash flow remains operational if inventory discipline aligns with price resets.
  • Working capital risk increases if a supplier builds inventory ahead of expected market price changes and later faces tender-driven price cuts.

What pricing and volume drivers matter most right now?

For erythromycin stearate, the near-term market outcome tends to hinge on:

  • Procurement tender wins and formulary inclusion
  • Multi-source competitive pricing at pharmacy and institutional levels
  • API cost volatility and supply disruptions
  • Shifts in antibiotic stewardship policies that alter macrolide selection behavior

What are the likely competitive and patent-related constraints?

Erythromycin stearate is an older drug product and is generally treated as an off-patent, generic landscape item. The competitive set is typically dominated by:

  • generic manufacturers of erythromycin stearate,
  • adjacent-competitor formulations (other erythromycin salts) when clinicians prefer a different GI tolerability or dosing schedule.

Practical implication for business planning

  • Differentiation is usually limited to supply reliability, pricing strategy, and packaging/formulation quality.
  • Commercial strategy tends to be procurement-focused rather than R&D-led.

How should an investor or R&D portfolio manager underwrite risk and upside?

For erythromycin stearate, underwriting is primarily a manufacturing-and-commercial execution problem:

Downside risks

  • further ASP erosion from price competition,
  • tender loss at institutional level,
  • supply interruptions (API or finishing),
  • macrolide utilization declines from guideline and resistance pressures.

Upside levers

  • cost-down via yield improvements and API scale,
  • supply assurance that wins repeat institutional contracts,
  • strength- and form-factor optimization for procurement preference,
  • fast response to shortages in competing products (if availability gaps occur).

Business decision: where does erythromycin stearate fit in a portfolio?

Erythromycin stearate is best treated as a mature, cash-generative generic candidate when:

  • a manufacturer has proven low-cost manufacturing,
  • procurement access is stable,
  • and supply chain performance supports contract continuity.

It is a weaker fit when:

  • the business depends on premium pricing or differentiation,
  • the operating model cannot absorb tender-driven price resets,
  • or antibiotic utilization risk is concentrated in macrolide-heavy portfolios.

Key Takeaways

  • Erythromycin stearate is a mature, generic antibiotic market where pricing pressure and procurement dynamics dominate the financial outcome.
  • Demand depends less on innovation and more on guideline-driven macrolide selection, resistance patterns, and seasonal infection cycles.
  • The financial trajectory typically shows flat-to-declining revenue due to ASP erosion, with margins stabilized only by sustained low COGS and supply reliability.
  • Commercial execution matters most: tender wins, formulary inclusion, API and manufacturing continuity, and inventory discipline around price resets.
  • Portfolio positioning should prioritize manufacturing efficiency and contract durability over R&D-driven upside assumptions.

FAQs

1) Is erythromycin stearate a growth drug or a mature cash-flow product?

It is a mature cash-flow product profile in most markets, with growth limited by generic competition and macrolide utilization pressures.

2) What drives profitability more: price or volume?

Price and gross margin compression typically dominate. Volume stability helps, but profitability improves mainly through cost-down and procurement execution.

3) How does resistance change the business outlook?

Resistance shifts prescribing away from macrolides when alternatives exist, reducing utilization and increasing price competition.

4) What matters most for winning institutional business?

Tender price, supply reliability, and lead-time performance. Institutional contracts reset quickly when competitors undercut costs.

5) What operational risks can hit quarterly results?

API or finishing supply interruptions, batch yield issues, and inventory misalignment with sudden price resets from competitor tendering.


References

[1] World Health Organization. Global antimicrobial resistance surveillance system (GLASS): reports and data. WHO. https://www.who.int/teams/global-anti-microbial-resistance-surveillance-system
[2] U.S. Food and Drug Administration. Drug shortages database. FDA. https://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
[3] IDSA (Infectious Diseases Society of America). Clinical practice guideline resources (macrolide use and stewardship guidance). IDSA. https://www.idsociety.org/guidelines/
[4] CDC. Antibiotic prescribing and resistance resources. Centers for Disease Control and Prevention. https://www.cdc.gov/antibiotic-use/

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