Last updated: February 25, 2026
What is the drug associated with NDC 00093-7620?
NDC 00093-7620 corresponds to Doxil (liposomal doxorubicin). Doxil is a chemotherapy agent used primarily for ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.
Market Overview
Market Size and Revenue
Doxil is a branded formulation of doxorubicin encapsulated in liposomes, improving drug delivery and reducing cardiotoxicity. The U.S. market for Doxil was estimated at approximately $400 million in 2022. The global market size was valued around $600 million in 2021.
Competitors and Alternatives
Major competitors include:
- Myocet — non-liposomal doxorubicin.
- Adcetris — alternative for certain lymphoma indications.
- Biosimilars and generics approved in markets outside the U.S., but limited within.
Regulatory Environment
- Doxil was granted orphan drug status for multiple indications.
- Patent protection expired in 2016, allowing for generic competition outside the U.S.
- U.S. patents were challenged and expired, but exclusivity retained via formulation patents until roughly 2024.
Key Market Dynamics
- Increasing cancer prevalence boosts demand.
- Growing use of liposomal formulations for reducing toxicity.
- Patent expiration led to entry of generics, lowering prices.
Price Trends and Projections
Historical Pricing Data
- Branded Doxil (prior to patent expiry): Wholesale acquisition cost (WAC) averaged $3,000–$4,000 per 1 mg vial.
- Post-patent expiration (2016 onward): generic liposomal doxorubicin priced $600–$900 per 10 mg vial.
- In 2022, the average wholesale price (AWP) for generics was approximately $750 per 10 mg, reflecting competitive market forces.
Future Price Estimates
Short-term (Next 2 Years):
- Prices are expected to stabilize at $700–$900 per 10 mg vial.
- Biosimilars entering the U.S. could reduce prices further.
Long-term (Next 5 Years):
- Price decline anticipated to reach $500–$700 per 10 mg due to increased generic competition.
- Market consolidation and supply chain efficiencies could exert downward pressure.
Factors Influencing Price Trajectory
- Patent status: Patent expiry in 2024 may lead to new generics.
- Market penetration: Adoption of biosimilars and new formulations.
- Regulatory shifts: Approval of biosimilars can push prices lower.
- Reimbursement policies: Insurance and Medicare adjustments impact pricing dynamics.
Key Market Trends
- Growing utilization of liposomal doxorubicin for reduced cardiotoxicity.
- Expansion of indications, including breast cancer and other solid tumors.
- Increasing adoption of biosimilars and generics post-patent expiration.
Risks and Uncertainties
- Slow uptake of biosimilars could sustain higher prices.
- Impact of new competitors or innovative therapies.
- Regulatory delays or changes affecting market access.
- Supply chain disruptions influencing pricing.
Summary Table: Price Projections (per 10 mg vial)
| Year |
Price Range (USD) |
Notes |
| 2023 |
$700–$900 |
Post-patent, initial generic competition |
| 2024 |
$600–$800 |
Increased biosimilar entry anticipated |
| 2025 |
$500–$700 |
Market stabilization with multiple biosimilars |
| 2026 |
$500–$700 |
Continued competition, price stabilization |
Key Takeaways
- Doxil (NDC 00093-7620) faces substantial generic competition since patent expiry around 2016.
- Market revenue remains significant, driven by its patent-protected formulations and expanding indications.
- Prices are forecasted to decline gradually over the next five years due to biosimilar entry and increased competition.
- Regulatory and reimbursement policies will influence pricing trends.
- The overall market is expected to stabilize at lower price points, but demand remains supported by clinical benefits.
FAQs
1. What are the primary indications for Doxil?
Doxil is used for ovarian cancer, multiple myeloma, and AIDS-related Kaposi’s sarcoma.
2. When did patent protection for Doxil expire?
U.S. patents expired around 2016, enabling generic competition.
3. How do biosimilars impact Doxil’s market?
Biosimilars can lower prices and expand access, possibly reducing Doxil’s market share.
4. What factors could alter future price projections?
Introduction of new therapies, regulatory changes, patent litigation, and supply factors.
5. Is there potential for new formulations or indications?
Yes, ongoing research could lead to new uses, but current market prices primarily reflect existing indications.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] EvaluatePharma. (2022). Global Oncology Market Report.
[3] FDA. (2022). Drug Approvals and Patent Expiry Dates.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies.
[5] BCC Research. (2021). Global Cancer Drug Market.
