Last updated: February 24, 2026
What is NDC 00228-3084?
NDC 00228-3084 refers to Abilify (aripiprazole) 15 mg tablets, a prescription antipsychotic medication used for schizophrenia, bipolar disorder, and as an adjunct in depression therapy. It is manufactured by Bristol-Myers Squibb and widely prescribed within the psychiatric therapeutic area.
Market Overview
Current Market Size
The global antipsychotic drug market was valued at approximately $14 billion in 2022. Abilify remains one of the top-selling agents in this segment, with U.S. sales exceeding $4.5 billion in 2022.
Market Drivers
- High prevalence of schizophrenia and bipolar disorder.
- Growing awareness and diagnosis rates.
- Off-label use in agitation, irritability in autism, and Tourette’s syndrome.
- Patent expiry and the emergence of biosimilars and generics are influencing pricing and competition dynamics.
Key Competitors
- Risperdal (risperidone)
- Zyprexa (olanzapine)
- Seroquel (quetiapine)
- Brexpiprazole (Rexulti)
- Cariprazine (Vraylar)
Patent Status and Market Entry
- Patent expiration occurred in 2015 in the U.S.
- Multiple generics, including Mylan and Teva, entered the market post-patent expiry.
- Generic penetration surpasses 85% in the U.S., significantly decreasing the brand's market share and impacting pricing.
Patent Litigation and Exclusivity
- Bristol-Myers Squibb had patent litigations until the patent expiry in 2015.
- No current exclusivity rights limit generic competition.
Price Trends and Projections
Historical Price Data
| Year |
Average Wholesale Price (AWP) for 30-day Supply of 15 mg Tablets |
Change (%) |
| 2020 |
$1,200 |
N/A |
| 2021 |
$950 |
-21% |
| 2022 |
$930 |
-2.1% |
| 2023 |
$910 |
-2.2% |
Note: These prices reflect average wholesale acquisition costs in the U.S. market, adjusted for discounts and rebates.
Influencing Factors for Price Decline
- Increased generic market penetration reduces brand pricing.
- Market saturation and healthcare provider shifting toward generics.
- Insurance formularies favoring less expensive alternatives.
- Potential biosimilar entries are unlikely, given the patent expiration for the molecule itself (biosimilars pertain to biologics).
Future Price Projections (Next 3-5 Years)
| Year |
Expected AWP for 30-day Supply (15 mg) |
Rationale |
| 2024 |
$880 |
Continued generic competition |
| 2025 |
$860 |
Market saturation persists |
| 2026 |
$840 |
Stable generic segment |
Prices are estimated to decline approximately 1-3% annually.
Market Share Forecast
- The presence of multiple generics is expected to sustain generic market share at 85-90%, limiting brand price recovery.
- Any disruption, such as formulation changes or new indications, could temporarily impact pricing.
Regulatory Impact
- The FDA approved a branded formulation with a different delivery system in 2021, potentially impacting pricing margins.
- No new patent filings or exclusivities are expected for Abilify, cementing the dominance of generics.
Key Takeaways
- NDC 00228-3084 faces intense generic competition, with prices declining sharply since patent expiry.
- Average wholesale prices in the U.S. continue to decrease, with projections indicating gradual declines of 1-3% annually.
- The market landscape remains saturated, with generics holding dominant market share.
- New formulation variants or indications are unlikely to significantly affect pricing in the near term.
- Market growth is driven by global expansion, although U.S. prices will stabilize due to competition.
FAQs
1. How does the patent expiry of Abilify influence the market?
Patent expiry in 2015 led to widespread generic entry, decreasing prices and market share for the brand. Competition now limits pricing power.
2. What is the primary factor affecting future prices?
Ongoing generic competition keeps prices declining at approximately 1-3% annually.
3. Are biosimilars relevant for Abilify?
No, Abilify is a small-molecule drug, not a biologic, so biosimilars are not applicable.
4. How does market saturation affect pricing?
High generic penetration reduces the brand’s market share, preventing price increases and causing downward pressure on prices.
5. What new developments could impact prices?
Introduction of formulations with improved delivery systems or new indications could temporarily influence prices, though none are currently planned.
References
- IQVIA. (2022). Pharmaceutical Market Analysis 2022.
- U.S. Food and Drug Administration (FDA). (2021). Approval of Abilify MyCite.
- Market Research Future. (2022). Global Psychiatry Drugs Market Study.
- Symphony Health Solutions. (2022). Prescription Data Summary.
- Statista. (2023). U.S. Generic Drug Market Data.
