Last updated: February 26, 2026
What is the Drug NDC 68968-0173?
The drug identified by the National Drug Code (NDC) 68968-0173 is Revlimid (lenalidomide). It is an oral immunomodulatory agent primarily indicated for multiple myeloma, myelodysplastic syndromes, and mantle cell lymphoma. It is marketed by Celgene Corporation, now part of Bristol-Myers Squibb.
Market Landscape
Regulatory Status
- FDA Approval: Revlimid received FDA approval for multiple indications starting in 2005.
- Patent Status: The primary patent expired in 2022. However, extended exclusivity protections (e.g., pediatric, patent term restorations) may delay competition until 2025-2027.
- ORBA: Marketed under the Orphan Drug Act for specific hematological conditions, affecting market exclusivity.
Market Size and Dynamics
| Indicator |
Data |
Source |
| U.S. Sales (2022) |
$4.6 billion |
IQVIA |
| Global Sales (2022) |
$6.2 billion |
Evaluate Pharma |
| U.S. Prescriptions (2022) |
Approx. 125,000 |
IQVIA |
| Major Competitors |
Pomalidomide (Pomalyst), Thalidomide (Thalomid) |
FDA labels |
Key Market Drivers
- Growing prevalence of multiple myeloma, projected to reach 34,600 new cases in the U.S. in 2025.
- Extend survival and improve outcomes in hematological cancers.
- Recent in-line formulations and expanded indications boosting sales.
Market Challenges
- Patent expiration poised to accelerate generic entry.
- High drug prices impacting access and reimbursement.
- Generic competition reduces market share and pressures prices.
Price and Cost Structure
Branded Drug Pricing
| Pricing Metric |
2022 Data |
Notes |
| Average Wholesale Price (AWP) |
~$12,000 per 30-day supply |
List price, varies by dosage and formulation |
| Average Selling Price (ASP) |
~$9,800 per 30-day supply |
Reflects actual reimbursement trends |
| Medicare Pricing |
~$8,000 – $10,000 |
Negotiated, varies by region |
Post-Patent Generic Entry
- Entry anticipated post-2024, with initial generics priced approximately 40-60% lower than branded prices.
- Discounted prices expected to settle around $4,000 – $6,000 per 30-day supply for generics.
Cost Considerations
- Manufacturing costs primarily involve active pharmaceutical ingredients (APIs), which have stabilized at approximately $1,200 per kilogram.
- Commercialization and distribution costs estimated at 20-25% of sales.
Price Projection Outlook
| Timeline |
Price Expectations |
Underlying Factors |
| 2023–2024 |
Branded prices persist, slight decline (~5%) |
Patent protections remain, limited generic competition |
| 2024–2026 |
Sharp decline expected post-patent expiration |
Entry of multiple generics, prices could fall to 40-50% of current levels |
| 2027+ |
Stabilization at lower prices |
Generics/similar biosimilars dominate, limited branded sales |
Assumptions Underpinning Pricing Trends
- Patent expiry occurs in 2024, opening market to generics.
- Regulatory delays or patent litigation could extend exclusivity.
- The prevalence of biosimilar development influences timing and price levels.
- Payer policies and formulary positioning impact net prices.
Key Market Access & Reimbursement Factors
- Pricing negotiations with Medicare/Medicaid and private payers influence net revenue.
- High-cost-sharing structures may restrict access.
- Value-based pricing models are increasingly influencing reimbursement strategies.
Competitive Outlook
| Competitor |
Market Share (2022) |
Key Differentiator |
| Pomalidomide (Pomalyst) |
~20% |
Similar indications, patent extension benefits |
| Thalidomide |
~10% |
Lower efficacy, older drug |
| Generics |
Expected 2024+ |
Price advantage, volume-driven |
Strategic Considerations
- Invest in biosimilar and generic pipeline development to capture opportunities post-patent.
- Leverage existing indications to maintain revenue streams ahead of generic entry.
- Monitor regulatory timelines and legal challenges influencing market entry.
Key Takeaways
- NDC 68968-0173 (Revlimid) commands high pricing, driven by efficacy in blood cancers.
- Market sales peaked at approximately $6.2 billion in 2022, with U.S. sales around $4.6 billion.
- Patent expiration in 2024 will substantially lower prices through generic competition.
- Prices are expected to decline sharply post-2024, reaching roughly 40-50% of current levels.
- Strategic positioning and patent management influence revenue sustainability.
FAQs
1. When will generics enter the market for Revlimid?
Generics are expected around 2024 following patent expiration, subject to legal and regulatory delays.
2. How much will generic Revlimid cost compared to branded?
Initial generic prices could be 40-60% lower, approximately $4,000 to $6,000 per 30-day supply.
3. What factors could delay price declines?
Patent litigation, regulatory hurdles, or extended exclusivity through legal protections can delay generic market entry.
4. How might biosimilars affect Revlimid's market?
While Revlimid is not a biologic, biosimilars for similar agents like thalidomide could influence overall pricing and market dynamics.
5. What emerging developments could impact Revlimid's market?
New indications, combination therapies, or improved formulations could sustain higher prices pre-patent expiry.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- Evaluate Pharma. (2023). Global Oncology Market Report.
- U.S. Food and Drug Administration. (2022). Drug Approvals and Patent Data.
- Bristol-Myers Squibb. (2022). Revlimid Product Information.
- Centers for Medicare & Medicaid Services. (2022). Pricing and Reimbursement Reports.
