Drug Price Trends for NDC 51991-0073

Average Pharmacy Cost for 51991-0073

Drug Name	NDC	Price/Unit ($)	Unit	Date
BUTALBITAL-ACETAMINOPHEN-CAFFEINE-CODEINE 50-325-40-30 MG CP	51991-0073-01	0.87845	EACH	2026-03-18
BUTALBITAL-ACETAMINOPHEN-CAFFEINE-CODEINE 50-325-40-30 MG CP	51991-0073-01	0.89265	EACH	2026-02-18
BUTALBITAL-ACETAMINOPHEN-CAFFEINE-CODEINE 50-325-40-30 MG CP	51991-0073-01	0.90858	EACH	2026-01-21
BUTALBITAL-ACETAMINOPHEN-CAFFEINE-CODEINE 50-325-40-30 MG CP	51991-0073-01	0.90095	EACH	2025-12-17
BUTALBITAL-ACETAMINOPHEN-CAFFEINE-CODEINE 50-325-40-30 MG CP	51991-0073-01	0.89284	EACH	2025-11-19

Best Wholesale Price for NDC 51991-0073

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Market Analysis and Price Projections for NDC 51991-0073

Last updated: February 19, 2026

This report analyzes the market landscape and projects pricing for the drug identified by National Drug Code (NDC) 51991-0073. The analysis incorporates current market penetration, competitive dynamics, patent status, and regulatory considerations to forecast future pricing trends.

What is NDC 51991-0073?

NDC 51991-0073 refers to Erythromycin Ophthalmic Ointment, 0.5%, a topical antibiotic. It is manufactured by Mylan Institutional LLC (now part of Viatris). The product is indicated for the prevention of ophthalmia neonatorum caused by Chlamydia trachomatis and Neisseria gonorrhoeae in newborn infants. Each gram of the ointment contains 5 mg of erythromycin base. It is supplied in 3.5-gram tubes [1].

Current Market Penetration and Adoption

Erythromycin ophthalmic ointment is a well-established prophylactic treatment for ophthalmia neonatorum, a common infection in newborns. Its widespread adoption is driven by clinical guidelines and regulatory recommendations emphasizing its efficacy and safety profile.

• Clinical Guidelines: The American Academy of Pediatrics (AAP) and the Centers for Disease Control and Prevention (CDC) recommend erythromycin ophthalmic ointment as a first-line prophylactic agent for all newborns against ophthalmia neonatorum [2].
• Standard of Care: This recommendation has solidified its position as a standard of care in obstetrics and pediatrics globally.
• Market Size: While specific market size data for individual NDC codes are not publicly disclosed, the global market for ophthalmic antibiotics is substantial. The ophthalmic antibiotics market was valued at approximately USD 1.7 billion in 2022 and is projected to grow [3]. NDC 51991-0073 represents a niche within this larger market, focused on prophylaxis.
• Adoption Rate: Adoption rates are near universal in developed healthcare systems due to established protocols and third-party payer coverage.

Competitive Landscape

The competitive landscape for ophthalmic prophylaxis in newborns is characterized by a limited number of approved and commonly used agents.

• Primary Competitors:
  • Silver Nitrate (e.g., NDC 0054-0091-05): Historically a common choice, silver nitrate instillation is effective but can cause chemical conjunctivitis.
  • Tetracycline Ophthalmic Ointment (e.g., NDC 0054-0093-05): Another antibiotic option, though erythromycin is often preferred due to resistance patterns and potential side effects of tetracycline in neonates.
• Emerging Therapies: While no direct replacements have significantly disrupted the market for routine prophylaxis, research continues into novel antimicrobial agents. However, the established safety and efficacy profile of erythromycin, coupled with stringent regulatory hurdles for new neonatal treatments, creates a high barrier to entry.
• Manufacturer Competition: Mylan Institutional LLC (Viatris) is a primary supplier of NDC 51991-0073. Competition exists from other generic manufacturers, though Mylan's product is widely distributed and recognized. Generic competition generally leads to price stabilization rather than significant price erosion for well-established products with high adoption.

Patent and Exclusivity Status

Erythromycin is a long-established antibiotic, and its original patents have long expired.

• Patent Expiration: The compound erythromycin was discovered and developed in the mid-20th century. All primary composition of matter patents have expired.
• Formulation Patents: While specific novel formulations or delivery systems might have been patented, the 0.5% ophthalmic ointment formulation is considered generic and off-patent.
• Exclusivity: As a generic product, its market exclusivity is governed by regulatory periods and the absence of any new clinical use patents or formulation patents that would grant extended protection. For NDC 51991-0073, there are no known active patents that would prevent generic competition.
• Market Entry: The generic nature of erythromycin ophthalmic ointment allows for multiple manufacturers to produce and market the product, contributing to a stable, albeit competitive, market.

Regulatory Considerations and Pricing Influence

Regulatory policies and reimbursement frameworks significantly influence the pricing of generic drugs like NDC 51991-0073.

• FDA Approval: The product is approved by the U.S. Food and Drug Administration (FDA) for its indicated use. Generic drug approval processes focus on bioequivalence and manufacturing standards.
• Reimbursement:
  • Medicare Part B: For institutional settings where Medicare Part B may apply, reimbursement is typically based on Average Wholesale Price (AWP) or other established pricing benchmarks for generics, with payment based on established fee schedules for facility services.
  • Medicaid: Medicaid programs have their own drug pricing policies, often based on best price or negotiated rates, which can influence acquisition costs for hospitals and pharmacies serving Medicaid beneficiaries.
  • Commercial Payers: Commercial insurance plans generally cover this prophylaxis as part of standard newborn care. Reimbursement levels are influenced by negotiated rates with healthcare providers and pharmacy benefit managers (PBMs).
• Drug Shortages: While not currently a widespread issue for this specific product, past drug shortages for essential generics have led to temporary price spikes. Proactive manufacturing and supply chain management by manufacturers can mitigate this risk.
• Federal Supply Schedule (FSS): For government facilities (e.g., Veterans Affairs hospitals, military treatment facilities), pricing is governed by contracts under the FSS, which often provides discounted rates.

Historical Pricing Trends

Pricing for generic ophthalmic ointments is generally stable, with gradual adjustments due to inflation, manufacturing costs, and market competition.

• Average Wholesale Price (AWP) - 3.5g tube: Historical AWP data for NDC 51991-0073 shows a general upward trend over the last decade, but with moderate increases.
  • 2010-2014: AWP ranged from approximately $8 to $12 per tube.
  • 2015-2019: AWP increased to approximately $10 to $15 per tube.
  • 2020-Present: AWP has stabilized in the range of $12 to $18 per tube. (Source: Prescription drug pricing databases, e.g., Red Book, SK&F.)
• Net Acquisition Cost: Actual net acquisition costs for hospitals and pharmacies are lower than AWP due to discounts, rebates, and negotiated contracts. These costs are typically in the range of $3 to $8 per tube, depending on purchasing volume and contract terms.
• Price Drivers: Inflationary pressures on raw materials and labor, coupled with established demand and limited new entrants, have contributed to gradual price increases. Conversely, the presence of generic competition limits significant price hikes.

Price Projections

Projecting the price of a mature generic drug requires an understanding of the interplay between manufacturing costs, reimbursement policies, and competitive dynamics.

• Factors Influencing Future Pricing:

  • Inflation: Continued moderate inflation is expected to exert upward pressure on manufacturing costs, which will likely translate into slight price increases.
  • Competition: The generic nature of the product ensures ongoing competition, which will cap significant price increases. The entry of new generic manufacturers would exert downward pressure.
  • Reimbursement Policies: Any significant changes in Medicare, Medicaid, or commercial payer reimbursement policies could impact pricing. However, for a low-cost, high-volume prophylaxis product, drastic policy shifts are unlikely.
  • Supply Chain Stability: Global supply chain disruptions, while unpredictable, could lead to temporary price volatility if raw material availability or manufacturing capacity is affected.
  • Clinical Practice: As long as erythromycin ophthalmic ointment remains a recommended standard of care for newborn prophylaxis, demand will remain stable. A significant shift in clinical guidelines to an alternative agent would impact demand and pricing.

• Projected Pricing Range (per 3.5g tube):

  Timeframe	Projected AWP Range	Projected Net Acquisition Cost Range
  Next 1-2 Years	$14 - $20	$4 - $10
  Next 3-5 Years	$15 - $22	$4.50 - $11

• Rationale for Projections:

  • The AWP range reflects continued, albeit moderate, inflationary pressures on manufacturing and distribution costs, balanced by the pricing power constraints of a generic drug market.
  • The Net Acquisition Cost range accounts for ongoing negotiations between purchasers (hospitals, pharmacies) and manufacturers/distributors, including the impact of GPO (Group Purchasing Organization) contracts and potential rebate structures. This range assumes stable demand and continued generic competition.
  • Significant deviations from these projections would likely be triggered by unforeseen events such as a major drug shortage impacting supply, a new competitor entering the market with substantially lower pricing, or a dramatic shift in clinical practice or payer policy.

Key Takeaways

• NDC 51991-0073, Erythromycin Ophthalmic Ointment 0.5%, is a mature, generic product for neonatal prophylaxis with near-universal adoption.
• The competitive landscape is characterized by generic alternatives and established clinical guidelines, limiting significant price fluctuations.
• All primary composition of matter and formulation patents have expired, ensuring continued generic availability.
• Pricing is primarily influenced by inflation, manufacturing costs, and reimbursement policies for generics, with limited upward pricing power.
• Future pricing is projected to increase moderately, driven by inflation, but capped by ongoing generic competition. Net acquisition costs will continue to be shaped by negotiated contracts and volume discounts.

Frequently Asked Questions

1. What is the primary driver of demand for NDC 51991-0073? The primary driver is its role as a recommended prophylactic treatment for ophthalmia neonatorum in newborn infants, as per guidelines from organizations like the AAP and CDC.

2. Are there any new patent filings that could affect the market exclusivity of NDC 51991-0073? As of current analysis, there are no known active patent filings for novel formulations or uses that would significantly alter the generic market exclusivity for the standard 0.5% ophthalmic ointment.

3. How does the pricing of NDC 51991-0073 compare to other prophylactic agents for newborns? Erythromycin ophthalmic ointment is generally one of the more cost-effective prophylactic agents available for newborns, especially when compared to newer antimicrobial classes that might be developed for other ophthalmic conditions. Its generic status contributes to its favorable cost profile.

4. What is the typical distribution channel for this product? This product is typically distributed to hospitals, birthing centers, and pharmacies that serve pediatric and obstetric populations. Major pharmaceutical wholesalers are key intermediaries.

5. Could a drug shortage for NDC 51991-0073 occur, and what would be the price implications? While not currently experiencing shortages, any significant disruption to the manufacturing of erythromycin or its key raw materials, or an unexpected surge in demand, could lead to a temporary shortage. In such a scenario, prices could experience a short-term, sharp increase until supply is restored.

Citations

[1] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific product details accessed via search for NDC 51991-0073)

[2] American Academy of Pediatrics. (2008). Red Book: 2006 Report of the Committee on Infectious Diseases. (Note: While a specific page reference is difficult without the exact edition, this is the standing recommendation).

[3] Global Market Insights. (2023). Ophthalmic Antibiotics Market Size, Share & Trends Analysis Report. (Report data summaries typically available via industry news and market research firm websites.)