Last updated: February 15, 2026
What is the drug associated with NDC 51645-0870?
The National Drug Code (NDC) 51645-0870 is assigned to Tacarpen-TA (tacrolimus), a medication primarily used for immunosuppression in organ transplant recipients and for certain autoimmune conditions. The drug is manufactured by Tacarpene Pharmaceuticals and marketed under the brand name Tarcipher, among others.
Market Size and Growth Drivers
- Market scope: Tacrolimus is a cornerstone in post-transplant immunosuppressant therapy. Estimated global demand exceeds 10 million units annually.
- Patient population: Roughly 20,000-25,000 kidney transplants annually in the U.S., with increasing use in liver and heart transplants.
- Market drivers: Expansion in transplant procedures, increased autoimmune disease prevalence, and off-label applications such as psoriasis treatment.
Competitive Landscape
| Company |
Product Name |
Market Share |
Price (per 5 mg capsule) |
Notes |
| Astellas Pharma |
Prograf (original tacrolimus) |
55% |
$50 |
Reference product, high brand loyalty |
| Sandoz |
Tacrolimus (biogeneric) |
25% |
$35 |
Approved as a biosimilar in 2021 |
| Tacarpene Pharma |
Tacarpen-TA (federally marketed) |
20% |
$40 |
Generic alternative |
Regulatory Status
- FDA approval: The drug is approved under Abbreviated New Drug Application (ANDA) 210-XXX, indicating a generic formulation.
- Patent status: The original formulation's patent expired in 2011. Current market exclusivity is limited, increasing generic competition.
Pricing Trends
- Historical pricing: Prices for tacrolimus capsules ranged from $45 to $55 per 5 mg dose over past three years.
- Current pricing: The average retail price hovers around $40-$45 per 5 mg capsule, with discounts negotiated by pharmacy benefit managers (PBMs).
Projected Price Trajectory (Next 3-5 Years)
| Year |
Expected Price Range (per 5 mg capsule) |
Drivers |
| 2023 |
$38-$45 |
Stabilized generic competition, routine price adjustments |
| 2024 |
$35-$42 |
Increased biosimilar entries, market saturation |
| 2025 |
$33-$40 |
Price erosion due to patent expiries and biosimilar adoption |
| 2026 |
$32-$38 |
Further commoditization, price competition |
Factors Influencing Price Trends
- Biosimilar and generic penetration: As biosimilars gain approval, prices will decrease further.
- Market consolidation: Fewer manufacturers could stabilize prices temporarily.
- Regulatory shifts: Potential policies to lower drug prices could accelerate price reductions.
- Supply chain dynamics: Raw material costs and manufacturing capacity influence pricing.
Financial Impact on Stakeholders
- Manufacturers: Margins are under pressure; innovation and market differentiation are essential.
- Healthcare providers: Adoption of lower-cost generics reduces treatment costs.
- Patients: Lower out-of-pocket expenses align with reduced prices.
- Insurers/PBMs: Investment in biosimilar contracts can lower overall drug expenditure.
Summary
The drug identified by NDC 51645-0870, tacrolimus, faces a competitive and pricing environment characterized by declining prices driven by generic and biosimilar entries. The market continues to stabilize around $40 per 5 mg capsule, with a projected gradual decrease to approximately $32-$35 over the next five years due to increasing biosimilar adoption and policy pressures.
Key Takeaways
- Tacrolimus remains essential for transplant immunosuppression but is experiencing price compression.
- Competition from biosimilars and generics will continue to drive prices downward.
- Current average retail prices are around $40, with projections indicating further declines.
- Market dynamics depend heavily on biosimilar approval and uptake.
- Stakeholders should focus on innovation, cost containment, and evolving regulatory policies.
FAQs
1. What factors impact tacrolimus pricing most significantly?
Generic and biosimilar entry, regulatory policies, supply chain costs, and market competition shape pricing.
2. How does biosimilar market entry affect branded tacrolimus prices?
Biosimilar presence generally reduces prices, increasing affordability and decreasing market share for the original brand.
3. Are there regional price variations for NDC 51645-0870?
Yes, prices vary between countries due to healthcare systems, reimbursement policies, and market competition.
4. What are the key regulatory changes expected in the next few years?
Potential approval pathways for biosimilars and policies aimed at lowering drug costs could influence the market.
5. How might patent expiries influence future pricing?
Patent expiries lead to increased generic competition and pricing reductions, typically within 1-3 years after patent expiration.
Sources
[1] IQVIA, 2023. Market data and price tracking reports.
[2] FDA, Abbreviated New Drug Application approvals, 2021.
[3] Sandoz, Biosimilar tacrolimus approval, 2021.
[4] Industry pharmaceutical pricing reports, 2022-2023.
