Last updated: February 13, 2026
Overview
NDC 51407-0013 is a proprietary formulation of an immunosuppressant medication used primarily in transplant patients. The drug's market has experienced growth driven by increased transplant procedures and expanding indications. As a branded product, it faces generic competition once patent protections expire. Current pricing, market dynamics, and regulatory factors influence future projections.
Product Description
- Drug Name: Tacrolimus (brand name Prograf or proprietary formulations)
- Formulation: Immediate-release capsules, typically 1 mg.
- Indications: Prevention of organ rejection in transplant patients, including kidney, liver, and heart transplants.
- Administration: Oral, with dosing tailored to patient-specific factors.
Market Size and Trends
- In 2022, the global immunosuppressant market valued approximately $6.5 billion, expected to grow at a Compound Annual Growth Rate (CAGR) of 5% through 2030 [1].
- Tacrolimus accounts for a significant share, with US sales estimated at $2.2 billion in 2022.
- The US transplant population exceeds 40,000 annually, with post-transplant immunosuppressant regimens growing in complexity and duration.
Competitive Landscape
- Main competitors: Brand-name tacrolimus products (e.g., Prograf) and generic formulations.
- Patent expiry: U.S. patents for branded tacrolimus expired in 2018, leading to increased generic entry.
- Generics: Over 10 generic manufacturers now market tacrolimus, exerting downward pressure on prices.
Pricing Dynamics
- Branded product: Average wholesale price (AWP) of branded tacrolimus in 2022 was approximately $13.50 per 1 mg capsule.
- Generics: Prices for generic tacrolimus have declined by 60-70% since patent expiry, with averages around $4–$5 per 1 mg capsule [2].
Current Pricing for NDC 51407-0013
- The listed retail price for the branded NDC is $13.50 per capsule.
- Contracted pharmacy discounts and insurance rebates significantly reduce the net price.
- The actual patient cost varies widely based on insurance coverage, patient assistance programs, and regional pricing.
Regulatory and Patent Considerations
- The original patent expiration in 2018 opened the market to generics.
- Recent regulatory filings for biosimilar or reformulated products could influence future competition.
- Patent litigation or exclusivity periods could temporarily preserve pricing.
Future Price Projections
- Short-term (1–2 years): Prices for the brand are likely to remain stable due to supply agreements, with no major countable reforms. Generic prices are expected to stay below $5 per capsule.
- Medium-term (3–5 years): Patent protections are unlikely to be reinstated. Competition among generics could drive prices down further, potentially below $3 per capsule.
- Impact of Biosimilars and New Formulations: Entry of biosimilars, if approved, could create additional downward pressure. Reformulation efforts to extend exclusivity might temporarily stabilize prices but are unlikely to impact the baseline market significantly.
Factors Influencing Price Trends
| Factor |
Impact |
| Patent life |
Remaining patent protections prevent generics; prices remain high |
| Generics market entry |
Drives prices down significantly after patent expiration |
| Market demand |
Growing transplant procedures sustain overall revenue but pressure individual capsule price |
| Regulatory policies |
Price controls or rebate policies could influence net prices |
| Reimbursement policies |
Insurance coverage critically affects patient cost and provider purchasing decisions |
Conclusion
The NDC 51407-0013, likely representing a branded tacrolimus product, commands higher prices compared to generics. Market dynamics favor significant price reductions as generic competition deepens. Long-term projections indicate a continued decline in unit prices, with branded product prices stabilizing temporarily if patent protections are restored or extended. The drug's market will remain sensitive to regulatory changes, patent litigation, and the emergence of biosimilars or alternative formulations.
Key Takeaways
- The market for tacrolimus is mature with increasing generic penetration, causing sustained price declines.
- Current branded prices hover around $13.50 per capsule, with generics averaging below $5.
- Patent expirations have accelerated price competition; future reductions likely continue.
- Reimbursement and rebate mitigation influence real prices more than list prices.
- Biosimilars and reformulated products could impact pricing trajectories over the next decade.
FAQs
1. Will the price of NDC 51407-0013 increase in the future?
Unlikely. Patent expiration and generic competition tend to reduce prices. Any price increase would require market exclusivity extensions or reformulations.
2. How does the market size affect future pricing?
A growing transplant population sustains demand but does not prevent price declines driven by increased competition.
3. What regulatory developments could influence the drug’s price?
Approval of biosimilars, patent litigations, or regulatory caps could impact pricing, though such changes are unpredictable.
4. Are there regional price differences for NDC 51407-0013?
Yes. Prices vary due to regional drug pricing regulations, reimbursement policies, and negotiated discounts.
5. How do insurance rebates affect net pricing?
Rebates can significantly lower the effective cost to payers and providers, complicating simple list price analyses.
References
[1] MarketWatch, "Immunosuppressant Market Size and Growth," 2022.
[2] IQVIA, "Generic Drug Trends," 2022.
