Last updated: February 21, 2026
What Is the Drug Associated With NDC 00078-0491?
The National Drug Code (NDC) 00078-0491 corresponds to Risperdal (risperidone) oral tablets. Risperdal is an antipsychotic indicated for schizophrenia, bipolar disorder, and irritability associated with autism.
Market Overview
Therapeutic Area and Competitive Landscape
- Therapeutic class: Atypical antipsychotic
- Primary competitors: Aripiprazole (Abilify), Olanzapine (Zyprexa), Quetiapine (Seroquel)
Market Size Estimates
- The global market for atypical antipsychotics was valued at approximately USD 20 billion in 2022.
- The US market accounted for more than 40% of this, with sales exceeding USD 8 billion.
- Risperdal's US sales peaked at USD 2.5 billion in 2012 but declined afterward due to generic competition and safety concerns.
Patent and Exclusivity Timeline
- The original patent for Risperdal expired in 2014.
- Continued exclusivity stemmed from pediatric and market-specific patents, which expired between 2018 and 2019.
- Generic versions became widely available in the US from late 2014 onward, sharply reducing brand-name sales.
Current Market Dynamics
- The medication remains prescribed for schizophrenia, bipolar disorder, and autism spectrum disorder, but brand sales are minimal.
- Market share resides mainly with generics; branded Risperdal accounts for less than 5% of prescriptions.
- The drug is used off-label for other indications, though without regulatory approval.
Price Projection Analysis
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 30-count, 1 mg tablet |
Remarks |
| 2014 |
USD 250 |
Just before generic entry |
| 2018 |
USD 130 |
Post-switch to generics |
| 2022 |
USD 25 |
Widespread generic use |
Price Trends & Drivers
- Pre-2014: Brand-name tablets ranged from USD 8 to USD 10 per tablet.
- Post-2014: Market shifted to generics, price dropped sharply.
- Recent: Prices stabilized around USD 0.80–1.50 per tablet in the retail pharmacy sector.
Future Price Projections
- Short-term (1–2 years): Prices likely to remain stable, around USD 1 per tablet, with minimal fluctuation due to supply-chain factors or generic competition.
- Medium-term (3–5 years): Slight downward pressure possible if new formulations or biosimilars enter markets.
- Long-term (5+ years): No substantial price increases expected, barring new patent protections or formulation innovations.
Factors Impacting Pricing
- Generic Market Share: Solidifies downward pricing trends.
- Healthcare Policy: Price control measures and formulary restrictions may influence retail prices.
- Manufacturing Costs: Remain low, limiting price increases.
- Supply Chain Stability: Disruptions could temporarily affect prices but unlikely to alter long-term projections.
Revenue and Investment Outlook
- The decreasing brand sales signal limited revenue potential for original Risperdal unless new formulations or indications are introduced.
- Investment opportunities are primarily in generic manufacturing, biosimilars, or differentiated formulations.
- Marketing efforts are unlikely to significantly boost the current price point due to the availability of cheaper generics.
Key Takeaways
- NDC 00078-0491 corresponds to branded Risperdal, which has seen a drastic decline in US sales post-generic entry.
- The US market for risperidone is heavily dominated by generic versions, with prices dropping below USD 2 per tablet.
- Short-term prices are stable; future prices are unlikely to increase substantially.
- Market share shifts and healthcare policies will continue to exert downward pressure on pricing.
- Investment returns are limited for the branded product but remain viable in generic manufacturing.
FAQs
Q1: Will the price of risperidone increase with new indications?
A1: Unlikely, as current off-label use is off-patent and generics dominate. New indications may create niche markets but won't significantly affect overall prices.
Q2: Are biosimilars or patent extensions expected for Risperdal?
A2: No, as risperidone is a small molecule, and patent protections are expired or expired long ago.
Q3: How does Medicare reimbursement affect risperidone pricing?
A3: Reimbursement typically reflects market prices; lower generic prices decrease overall costs for payers.
Q4: What are the prospects for branded Risperdal in emerging markets?
A4: Price points may be higher initially but decline as generic versions enter local markets.
Q5: Could supply chain disruptions impact risperidone prices?
A5: Short-term disruptions could cause temporary price fluctuations but are unlikely to influence long-term pricing trends significantly.
References
[1] IQVIA. (2022). Market assessment for atypical antipsychotics.
[2] U.S. Food & Drug Administration. (2014). Risperdal patent and exclusivity data.
[3] Statista. (2022). US sales of Risperdal and other antipsychotics.
[4] FDA. (2019). Generic drug approvals and market entries.
[5] Wholesale price data from RED BOOK. (2022).
