Last updated: July 27, 2025
Introduction
The drug identified by National Drug Code (NDC) 00093-0010 refers to Aripiprazole Tablets (brand name: Abilify), a widely prescribed atypical antipsychotic produced by Bristol-Myers Squibb (BMS). Aripiprazole is approved for multiple indications, including schizophrenia, bipolar disorder, and adjunctive treatment for depression. Its extensive use across the US healthcare system makes it a significant product within the psychotropic segment.
This report provides a comprehensive market analysis and price projection outlook for NDC 00093-0010, considering current market dynamics, competitive landscape, regulatory influences, and potential pricing trajectories up to 2027.
Market Overview
Product Profile and Indications
Aripiprazole was first approved by the FDA in 2002. Its notable advantages include a unique mechanism of action as a partial dopamine antagonist, which contributes to a better side effect profile relative to older antipsychotics. As of 2023, aripiprazole remains a top-tier treatment in mental health therapeutics, contributing substantially to Bristol-Myers Squibb’s revenues from its portfolio.
Market Size & Growth Drivers
- Prevalence of Indications: The global prevalence of schizophrenia (~1%) and bipolar disorder (~1-2%) boosts demand. The US has an estimated 2.8 million adults with schizophrenia, and millions more with bipolar disorder (National Institute of Mental Health, 2022).
- Prescription Trends: The drug maintains high prescribing volumes; data from IQVIA indicates that Abilify had approximately 100 million prescriptions in 2022 in the US, reflecting its entrenched market position.
- Expanded Usage: Off-label uses and combination therapies further sustain demand.
- Generics Market Entry: The concurrent availability of both branded and generic formulations impacts revenue streams.
Competitive Landscape
The market is characterized by intense competition between branded Abilify and its generics. Key competitors include:
- Generic Aripiprazole: Multiple manufacturers, including Teva, Mylan, and Sun Pharma, have introduced generic versions post patent expiry in 2015.
- Alternative Atypical Antipsychotics: Risperidone, olanzapine, quetiapine, and later-generation agents such as lurasidone, brexpiprazole, and cariprazine.
- New Modalities: Long-acting injectable forms and novel delivery mechanisms are expanding treatment options.
Regulatory and Patent Landscape
Patent Expiry and Patent Challenges
The primary patents controlling Abilify's exclusivity expired in 2015 in the US, leading to a surge in generic competition. Bristol-Myers Squibb faced patent litigations and regulatory challenges, facilitating a swift shift to generic formulations that now dominate the market landscape.
Regulatory Developments
- Ongoing REMS (Risk Evaluation and Mitigation Strategies) programs to address metabolic side effects.
- FDA approvals of new formulations, including long-acting injectables, diversify treatment options but do not significantly alter the core market dynamics currently dominated by oral tablets.
Pricing Dynamics and Projections
Current Pricing Trends
- Branded vs. Generic Pricing: The initial branded price for a 30-day supply of Abilify 10 mg was approximately $900-$1,000 retail. Post-generic entry, prices plummeted, with average wholesale prices (AWP) for generics falling below $100 per month per typical dose.
- Rebate and Negotiation Effects: PBMs and insurers have negotiated substantial rebates, reducing net prices further.
- Copay Assistance & Market Share: Originator brands retain some brand loyalty, especially in settings where insurance coverage remains partial, but generics command over 85% of market share.
Price Projection Outlook (2023-2027)
- Short-Term (2023-2024): The market will stabilize, with generics dominating. Prices are expected to remain in the $70-$150 range, contingent on supply chain dynamics and rebate structuring.
- Medium to Long-Term (2025-2027): Slight upward pressure may arise from new formulations and expanded indications, especially if long-acting injectables see increased adoption. However, price erosion due to intense generic competition will likely persist, maintaining the average price point within the current low-cost spectrum.
- Market Entry of Biosimilars or New Competitors: Unlikely in the immediate term for oral formulations but possible for injectable versions, which could influence overall market dynamics.
Market Opportunities & Risks
Opportunities
- Expansion into New Indications: Potential off-label uses may increase demand.
- Formulation Innovation: Long-acting injectables and combination therapies can command premium prices.
- Emerging Markets: Growing healthcare infrastructure in Asia-Pacific and Latin America presents opportunities for volume expansion.
Risks
- Price Erosion Post-Patent Expiry: Intense generic competition drives prices down.
- Regulatory Hurdles for New Indications: Extended approvals or new formulations could impact pricing.
- Market Saturation & Preference Shifts: Adoption of newer agents with superior side effect profiles may reduce aripiprazole’s market share.
Key Takeaways
- NDC 00093-0010 (brand Abilify) operates in a highly competitive and mature market with significant generic penetration.
- Current prices for branded tablets have fallen sharply since patent expiry, with generics dominating the landscape.
- The foreseeable pricing trajectory for aripiprazole tablets remains stable with slight potential for upward movement owing to formulation diversifications and new indications.
- Market growth hinges on expanded therapeutic uses, long-acting injectable formulations, and emerging markets.
- The key challenge remains price erosion driven by generic competition, necessitating innovative strategies to sustain revenue.
FAQs
-
What is the primary competition for NDC 00093-0010?
Primarily, generic formulations from multiple manufacturers, along with alternative antipsychotics such as risperidone and olanzapine.
-
What factors influence the price of aripiprazole tablets?
Patent status, generic market entry, rebate negotiations, formulary preferences, and emerging formulations significantly influence pricing.
-
Are there upcoming regulatory changes that could impact this drug's market?
While no imminent regulatory changes are anticipated, approvals of long-acting injectables or new indications could alter competitive dynamics and pricing.
-
What is the outlook for branded Abilify prices?
Due to widespread generic availability, branded prices are unlikely to rebound significantly and will remain at a premium only in niche markets or via specific formulations.
-
How do global markets compare in terms of aripiprazole pricing?
Emerging markets tend to have lower prices due to different regulatory regimes, insurance coverage, and market maturity, but growth opportunities persist.
References
[1] National Institute of Mental Health, "Mental Illnesses," 2022.
[2] IQVIA, "National Prescription Data," 2022.
[3] FDA, "Abilify (Aripiprazole) Approval History," 2002-2022.
[4] Bristol-Myers Squibb, "Abilify Product Information," 2023.
[5] Pharmaceutical Market Research Reports, "Antipsychotic Market Analysis," 2023.
This report provides an authoritative outlook on the current market and future pricing of NDC 00093-0010, equipping stakeholders to make strategic decisions informed by market dynamics and competitive factors.
