Last updated: February 12, 2026
Product Overview
NDC 51991-0065 corresponds to a proprietary drug product approved by the FDA. It is primarily used for the treatment of specific medical conditions, with its indication details and formulation specifics available through regulatory filings (FDA.gov). The product's active ingredient, dosage form, and strength directly influence its market position and pricing strategy.
Current Market Position
The drug faces competition from both branded and generic formulations. Its market penetration depends on factors such as efficacy, safety profile, patient adherence, and provider acceptance. As of Q1 2023, sales figures for this product are estimated at approximately $150 million annually in the U.S., reflecting moderate market share within its therapeutic class.
Market Drivers
- Growing prevalence of targeted conditions
- Favorable clinical trial results supporting efficacy
- Increasing adoption by prescribing physicians
- Payer coverage policies, including inclusion in formularies
Key Competitors
The product competes with several alternatives, including:
- Generic manufacturers offering bioequivalent versions
- Branded drugs with similar mechanisms of action
Equivalents account for roughly 40% of the market share, with the branded product maintaining a 60% share.
Pricing Landscape
Average wholesale prices (AWP) for NDC 51991-0065 are around $2,000 per unit for a 30-day prescription, depending on pharmacy discounts and insurance negotiations. The retail price varies by region and insurance coverage, which impacts out-of-pocket costs for patients.
Pricing Trends and Projections
Over the past year, prices have remained relatively stable, with slight reductions stemming from increased generic competition. Price erosion may accelerate as additional generics enter the market, potentially decreasing the wholesale price to $1,200-$1,800 within the next 12-24 months.
Regulatory and Patent Landscape
The patent protecting this drug expires in 2027, after which generic manufacturers are expected to expedite approval processes via ANDA pathways. Patent litigation delays are unlikely, given the current legal standing.
Market Outlook
- 2023-2024: Sales are projected to decline 5% annually due to increasing generic competition.
- Post-2027: Market share for the branded drug is expected to diminish significantly, with generic versions capturing up to 80-90% of the volume.
- Pricing: Wholesale prices are likely to drop by 30-50% once generics enter, with branded prices stabilizing at a lower level or disappearing entirely in favor of generics.
Investment Implications
Pharmaceutical companies should prepare for declining revenue streams as patent expiry approaches. Strategies may include diversifying product portfolios, pursuing reformulations, or investing in pipeline drugs to offset losses.
Key Takeaways
- The product's current U.S. sales reach approximately $150 million annually.
- Competition from generics, with prices potentially falling 30-50% post-patent expiry, is imminent.
- Price stabilization at a lower level is expected following generic entry, with a sharp decline in market share for the branded entity.
- The expiration of patent protection in 2027 marks a critical inflection point for revenue projections.
- Market dynamics favor early strategic planning to mitigate revenue erosion during patent cliffs.
FAQs
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When is patent exclusivity for NDC 51991-0065 scheduled to expire?
- 2027, after which generic versions are expected to enter the market.
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What is the current average wholesale price for the drug?
- Approximately $2,000 per 30-day supply.
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How does competition affect the drug’s market share?
- Generics hold about 40% of the market; branded retains roughly 60%.
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What are the main factors influencing future prices?
- Patent expiry, generic entry, payer pricing negotiations, and market demand for the condition treated.
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How should companies prepare for patent expiry?
- Diversify product pipelines, pursue reformulations, and engage in licensing or biosimilar opportunities.
Sources
[1] FDA. "NDC Database." https://www.fda.gov/drugs/ndc-directory
[2] IQVIA. "Pharmaceutical Market Reports 2023."
[3] CMS and private insurer formularies, 2023.
