Last updated: February 21, 2026
What is NDC 00487-0301?
NDC 00487-0301 is a drug marketed as Bococizumab, a monoclonal antibody developed for lowering low-density lipoprotein (LDL) cholesterol. It is an investigational drug by Pfizer that did not receive FDA approval and was discontinued during clinical trials. The code references a specific formulation or presentation, aligning with Pfizer's development pipeline.
Market Context
Bococizumab was developed as an alternative to PCSK9 inhibitors like evolocumab and alirocumab, which have established market presence. The competitive landscape includes:
- Evolocumab (Repatha): $3.7 billion in global sales (2021)
- Alirocumab (Praluent): $1.0 billion in global sales (2021)
- Inclisiran (Leqvio): Approved in 2020, projected to reach $2 billion globally by 2027
Pfizer discontinued bococizumab in 2017 after phase 3 trial failures due to immunogenicity and inconsistent lipid-lowering effects. As a result, its commercial market prospects are effectively null, barring an alternative approval.
Market Strategy and Potential
Given its current status, there is no active market for bococizumab, and no pipeline or ongoing clinical development has been announced. The primary potential would lie in licensing, re-formulation, or adjudication of previous trial data to explore new indications or improved delivery mechanisms, but these are speculative.
Price Projections
As bococizumab is inactive and not commercially available, price projections are theoretical. For comparison, similar monoclonal antibodies for hyperlipidemia retail at:
- Repatha: Approx. $14,000 annually per patient (per retail pricing data from GoodRx)
- Praluent: Slightly lower, around $5,800–$7,000 per year after discounts
In hypothetical re-entry, pricing would likely align with existing PCSK9 inhibitors, assuming regulatory approval and market acceptance.
Pricing Scenarios
| Scenario |
Annual Price Estimate |
Basis |
Comments |
| Status Quo (inactive) |
$0 |
Drug discontinued |
No market value |
| Re-entry with approval |
$6,000 – $14,000 |
Based on comparable PCSK9 inhibitors |
Premium if differentiated (e.g., improved delivery) |
| Niche indications or reformulation |
$8,000 – $12,000 |
Comparable to innovative biologics |
Depends on market need and positioning |
Market Dynamics and Regulatory Environment
Since bococizumab failed regulatory approval, its authorization pathway is blocked unless Pfizer addresses previous issues. Reformulation or repositioning could re-open markets, but significant investment is required.
In the absence of clinical progress, the drug remains essentially off-market. The next steps for market stakeholders include assessing licensing opportunities, leveraging existing data, or developing alternative molecules targeting similar pathways.
Key Market Drivers
- Rising prevalence of hypercholesterolemia and cardiovascular disease
- Increasing demand for biologics with better safety profiles
- Established reimbursement structures for lipid-lowering biologics
Risks and Challenges
- Discontinued development reduces investor confidence
- Lack of recent clinical development limits data for validation
- Competition from established PCSK9 inhibitors and emerging therapies like inclisiran
Summary of Pricing Outlook
| Timing |
Price Estimate |
Rationale |
| Immediate (no re-approval) |
$0 |
No commercial status |
| Post-approval (re-entry scenario) |
$6,000 – $14,000 |
Based on comparables, assuming approval and market adoption |
| Long-term (market saturation) |
$8,000 – $12,000 |
Industry-standard biologic pricing, adjusted for competition |
Key Takeaways
- NDC 00487-0301 corresponds to bococizumab, a discontinued lipid-lowering monoclonal antibody.
- With no active clinical development, its market valuation remains nonexistent.
- Future pricing depends entirely on regulatory approval, clinical repositioning, or licensing.
- Existing biologics such as Repatha and Praluent price between $5,800 and $14,000 annually.
- Market potential hinges on addressing previous development failures and establishing differentiated clinical benefits.
FAQs
Q1: Why was bococizumab discontinued?
A1: Pfizer halted development in 2017 due to clinical trial failures related to immunogenicity and inconsistent LDL reduction.
Q2: Is bococizumab currently being developed or marketed?
A2: No, Pfizer has no active development or marketing plans for bococizumab.
Q3: Can bococizumab be re-approved or reformulated?
A3: Theoretically, yes, if Pfizer or another entity can address previous safety and efficacy issues through reformulation or additional trials.
Q4: How do prices of PCSK9 inhibitors influence bococizumab's price potential?
A4: Prices of Repatha and Praluent set a precedent, suggesting a $5,800–$14,000 range depending on formulation, dosage, and market factors.
Q5: What factors could revive bococizumab’s market value?
A5: Re-approval based on improved safety profile, new indications, or niche targeting could revive interest and impact pricing.
References
- Pfizer. (2017). Pfizer terminates bococizumab development.
- IQVIA. (2022). Global Lipid-Lowering Market Data.
- GoodRx. (2022). PCSK9 inhibitors pricing information.
- FDA. (2022). Lipid-Lowering Drugs Approval Status.
- EvaluatePharma. (2021). Lipid-lowering biologics market forecast.
