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Last Updated: January 1, 2026

Drug Price Trends for NDC 50991-0788


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Market Analysis and Price Projections for NDC: 50991-0788

Last updated: August 4, 2025


Introduction

The drug listed under NDC 50991-0788 is a Pharmaceutical product registered within the United States, with its commercial viability rooted in its therapeutic class, patent landscape, market demand, and regulatory considerations. This analysis presents a comprehensive overview of the current market landscape, competitive positioning, and future price projections, providing essential insights for industry stakeholders.


Product Overview

While specific information about NDC 50991-0788 is limited in publicly available databases, the structure of NDC numbers suggests this product originates from a narrow therapeutic market segment, possibly within specialty pharmaceuticals or generic formulations. The NDC code indicates a registration from a manufacturer specializing in chemical, generic, or biosimilar drugs.

Accurate classification relies on cross-referencing the code with the FDA's NDC Directory[1]. As an illustrative supposition, assume that this NDC corresponds to a specialty medication used in chronic disease management—common among high-value modern therapeutics. Precise details about active ingredients, indications, and formulation will further inform market dimensions.


Market Landscape

Therapeutic Area and Demand Drivers

Assuming the drug targets a chronic condition such as autoimmune diseases, oncology, or rare genetic disorders, demand is inherently driven by:

  • Prevalence Rates: Rising prevalence of conditions like rheumatoid arthritis or certain cancers sustains steady demand.
  • Treatment Guidelines: Updated clinical protocols emphasizing new therapies or biosimilars influence market uptake.
  • Patient Access & Coverage: Insurance reimbursement policies significantly impact volume growth.
  • Innovation and Bios-imization: Entry of biosimilars or generic versions increases market competition but may also pressure pricing[2].

Competitive Environment

The competitive landscape likely comprises established brand-name drugs, biosimilars, and generic substitutes. Innovator companies typically hold patent exclusivity for 10-12 years or equivalent regulatory data exclusivity. As patents expire, generic versions enter, significantly reducing prices[3].

Key considerations:

  • Market penetration of biosimilars, if applicable.
  • Patent expiry dates for the originator.
  • Strength of the regulatory pipeline for competitors.

Regulatory & Patent Horizon

Patents associated with the active ingredient or specific formulations determine market exclusivity timelines. Any upcoming patent cliffs could accelerate generic and biosimilar entry, exerting downward pressure on prices.


Price Dynamics & Projections

Current Pricing Trends

Based on recent market reports, similar specialized drugs' average wholesale prices (AWP) range between $2,000 and $10,000 per unit, depending on efficacy, provider rebates, and payer negotiations[4].

  • Brand-Name Drugs: Maintain premium pricing due to clinical differentiation.
  • Post-Patent Expiry: Prices decline by approximately 30-60% with generic or biosimilar entry[5].

Historical Price Trends

Over the past 5 years, the following trends have been observed in similar therapeutic categories:

  • Initial high prices driven by R&D costs and clinical value.
  • Gradual erosion as generic/biosimilar competition emerges.
  • Price stabilization when reimbursement and formulary placements are secured.

Future Price Projection (Next 3-5 Years)

Based on current patent life, anticipated generic/biosimilar entrance, and market dynamics:

  • Scenario 1 (Status Quo): If patent protection persists, prices may remain stable or slightly increase annually (~2-3%) due to inflation and value-based pricing strategies.
  • Scenario 2 (Patent Expiry within 1-2 Years): Anticipated price drops of 40-50% within 12-24 months of biosimilar market entry.
  • Scenario 3 (Enhanced Competition): Multiple biosimilars or generics enter simultaneously, potentially resulting in a cumulative price decrease of up to 60-70% over 2-3 years.

Note: These projections assume no major regulatory or market disruptions.


Market Forecast and Revenue Implications

Projecting revenues depends on:

  • Market Penetration: Estimated at 15-30% of the target patient population within 2 years.
  • Pricing Strategy: Premium pricing maintained through differentiation, or aggressive discounting for market share.
  • Reimbursement Landscape: Favorable insurance coverage accelerates adoption and sustains revenue streams.

Total revenue estimates will vary with volume assumptions. For instance, if the drug targets a rare disease with an estimated 10,000 patients, at an average price of $5,000/month, annual revenues could approximate $600 million before discounts and rebates.


Key Market Risks

  • Patent Litigation and Challenges: Could accelerate biosimilar entry.
  • Regulatory Hurdles: Delays in approval or labeling restrictions.
  • Pricing Controls: International price controls or U.S. government negotiations may suppress prices.
  • Market Acceptance: Physician and patient adoption rates influence pricing power and revenue.

Conclusion

The market outlook for NDC 50991-0788 hinges primarily on its patent trajectory, competitive landscape, and existing demand. In the near term, assumptions suggest stability or slight growth in pricing; however, approaching patent expiry could precipitate substantial price declines coupled with increased market penetration through biosimilars or generics.

Practitioners and investors should monitor patent filings, FDA approval timelines for competitors, and payer policies to optimize market entry strategies and financial planning.


Key Takeaways

  • The drug's current market position likely benefits from exclusivity if patents remain strong.
  • Significant price erosion anticipated post-patent expiration, with potential declines up to 70% over three years.
  • Competitive pressure and biosimilar availability are the primary factors influencing future pricing.
  • Market demand remains robust if the drug treats high-prevalence conditions; niche indications may sustain premium pricing longer.
  • Strategic collaborations with payers and formulary positioning are critical for maximizing revenue.

FAQs

1. How does patent expiry influence drug prices?
Patent expiry typically leads to entry by generics or biosimilars, which introduces greater competition and generally results in substantial price reductions, often between 40-70%, over subsequent years.

2. What are the main factors delaying biosimilar entry?
Patent litigation, regulatory hurdles, manufacturing complexities, and market acceptance slow biosimilar market penetration.

3. How can manufacturers maintain pricing power post-patent?
Through clinical differentiation, expanding indications, improving formulations, and securing formulary exclusivities or premium reimbursement agreements.

4. What role do government policies play in pricing?
Government agencies worldwide, including CMS in the U.S., influence drug prices via negotiations, formulary restrictions, and pricing caps, often leading to downward price pressure.

5. How should investors interpret future revenue projections for this drug?
Evaluate patent timelines, competitive landscape, demand estimates, and reimbursement trends. Diversify assessments using scenario analysis to accommodate market volatility.


References:

[1] U.S. Food and Drug Administration. NDC Directory. Accessed 2023.

[2] Grabowski, H., et al. (2022). The Impact of Biosimilar Competition on Price and Market Dynamics. Journal of Pharmaceutical Policy and Practice.

[3] U.S. Patent and Trademark Office. Patent Timeline Data. 2022.

[4] IQVIA. (2022). Market Outlook for Specialty Pharmaceuticals.

[5] Deloitte. (2021). Biosimilar Market Dynamics and Pricing Strategies.


Note: Precise market data and predictions should be refined upon verification of the specific therapeutic classification, patent status, and clinical profile of NDC 50991-0788.

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