Last updated: March 3, 2026
What is NDC 62135-0740?
NDC 62135-0740 refers to a specific drug identified within the National Drug Code (NDC) system. Based on the code structure and publicly available databases, this NDC corresponds to Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a radiopharmaceutical used for treatment of metastatic castration-resistant prostate cancer (mCRPC).
Market Overview
Regulatory Status
Pluvicto received FDA approval on March 23, 2022, under expedited pathways (FDA, 2022). It is indicated for adult patients with PSMA-positive mCRPC who have been previously treated with androgen receptor pathway inhibitors and chemotherapy.
Market Size
The global prostate cancer market was valued at $7.4 billion in 2021, with radiopharmaceuticals constituting approximately 5% (Grand View Research, 2022). The specific segment for PSMA-targeting therapies, including Pluvicto, is credited with rapid growth projections.
Sales and Adoption Trends
Since approval, Pluvicto has seen steady uptake among oncologists specializing in prostate cancer. As of late 2022, sales estimates approximate $200 million globally. The drug's price is a key factor influencing market penetration.
Pricing Details
Current List Price
Registrar sources indicate the wholesale acquisition cost (WAC) for a single dose (~7.4 GBq or 200 mCi) of Pluvicto ranges from $22,500 to $25,000 per dose. This price covers the drug alone, excluding administration and facility fees.
| Parameter |
Details |
| Estimated WAC per dose |
$23,000 - $25,000 |
| Dosing frequency |
Every 6-8 weeks, typically 4-6 doses total |
| Total treatment cost |
$92,000 - $150,000 |
Reimbursement Landscape
Centers for Medicare & Medicaid Services (CMS) reimburse Pluvicto via the American Medical Association's (AMA) HCPCS code (C9294). Reimbursement rates average between $25,000 and $28,000 per dose, with variations based on geographic location and facility.
Comparative Pricing
Compared to other treatments for mCRPC, such as chemotherapy or androgen receptor inhibitors, Pluvicto's pricing is higher per course but may offer better efficacy in specific patient populations.
Market Drivers
- Regulatory approval in multiple countries enhances access.
- Increased awareness among oncologists regarding PSMA-targeted radioligand therapy.
- Reimbursement coverage expanding across Medicare and private insurers.
- Growing incidence of prostate cancer, projected to reach over 300,000 new cases annually in the US by 2030 (SEER, 2021).
Market Barriers
- Limited production capacity of radiolabeled drugs.
- Logistical challenges due to the heavy handling and short half-life (about 6.7 days) of lutetium-177.
- Pricing negotiations and policy restrictions affecting reimbursement levels.
- Competition from emerging PSMA-targeted agents, including antibody-drug conjugates or next-generation radioligands.
Price Projections (2023-2028)
| Year |
Projected WAC per Dose |
Estimated Revenue |
Key Comments |
| 2023 |
$23,000 |
$350 million |
Rapid initial uptake, stabilized hospital procurement. |
| 2024 |
$22,500 |
$500 million |
Slight price erosion as competition emerges. |
| 2025 |
$21,500 |
$600 million |
Increased production capacity, expanded access. |
| 2026 |
$20,500 |
$750 million |
Broadened indications and new markets. |
| 2027 |
$19,500 |
$900 million |
Potential price adjustments amid reimbursement negotiations. |
| 2028 |
$19,000 |
$1 billion |
Market maturation, more competitors. |
Note: Prices are in US dollars, based on industry trends, and may adjust with policy changes.
Competitive Landscape
| Drug/Technology |
Indication |
Status |
Price Range (per dose) |
| Lutetium Lu 177 vipivotide tetraxetan (Pluvicto) |
mCRPC PSMA-positive |
Approved (2022) |
$22,500 - $25,000 |
| 177Lu-PSMA-617 (under clinical evaluation) |
mCRPC |
Clinical trials ongoing |
Varies, ~$20,000 (estimated) |
| Other PSMA-targeted agents |
mCRPC |
Experimental/early stages |
N/A |
Key Takeaways
- NDC 62135-0740 corresponds to Pluvicto, a radiolabeled therapy for advanced prostate cancer.
- The drug commands a wholesale price near $23,000 per dose, with total treatment costs exceeding $100,000.
- Market growth is driven by increased approvals, adoption, and reimbursement expansion.
- Price projections suggest gradual price reductions driven by competition and increased manufacturing capacity, with global revenue potentially surpassing $1 billion annually by 2028.
FAQs
1. What factors influence the pricing of NDC 62135-0740?
Pricing is impacted by manufacturing costs, reimbursement negotiations, market competition, and regulatory policies.
2. How does Pluvicto compare to other prostate cancer treatments?
Pluvicto offers targeted radioligand therapy, with different efficacy profiles and cost considerations compared to chemotherapy or hormonal agents.
3. Will the price of Pluvicto decline over time?
Potentially, due to increased manufacturing efficiency, competition, and policy negotiations, leading to price erosion.
4. Are there regional differences in pricing?
Yes, prices vary across countries, driven by reimbursement policies and healthcare system structures.
5. What is the outlook for future PSMA-targeted radioligands?
Emerging agents and second-generation therapies may intensify competition, potentially impacting prices and market share.
References
[1] FDA. (2022). FDA approves Lutetium Lu 177 vipivotide tetraxetan for prostate cancer.
[2] Grand View Research. (2022). Prostate Cancer Therapeutics Market Size, Share & Trends.
[3] SEER. (2021). Cancer Statistics Review.
