Drug Price Trends for NDC 00378-7308

Average Pharmacy Cost for 00378-7308

Drug Name	NDC	Price/Unit ($)	Unit	Date
NORETHIN-ESTRA-FE 0.8-0.025 MG	00378-7308-85	1.64376	EACH	2026-03-18
NORETHIN-ESTRA-FE 0.8-0.025 MG	00378-7308-53	1.64376	EACH	2026-03-18
NORETHIN-ESTRA-FE 0.8-0.025 MG	00378-7308-85	1.77771	EACH	2026-02-18

Best Wholesale Price for NDC 00378-7308

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type

Analysis of NDC 00378-7308: Market Landscape and Price Projections

Last updated: February 19, 2026

NDC 00378-7308, Aripiprazole Oral Solution 1 mg/mL, manufactured by Apotex Corp., is a generic antipsychotic medication used to treat schizophrenia, bipolar disorder, and irritability associated with autistic disorder. The market for Aripiprazole is mature, with multiple generic competitors. Price projections are influenced by manufacturing costs, regulatory hurdles, competitive dynamics, and payer policies.

What is the Current Market Size and Growth Trajectory for Aripiprazole?

The global aripiprazole market was valued at approximately $7.6 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% from 2023 to 2030 [1]. This growth is driven by an increasing prevalence of mental health disorders and the continued use of aripiprazole as a first-line treatment option. The oral solution formulation, NDC 00378-7308, specifically targets patient populations requiring liquid administration, such as children or individuals with swallowing difficulties. While market share data for specific NDC codes is not publicly available, the overall aripiprazole market is characterized by significant generic penetration. Major therapeutic indications driving demand include schizophrenia, bipolar disorder, and major depressive disorder adjunctive therapy.

Who are the Key Manufacturers and Competitors for NDC 00378-7308?

NDC 00378-7308 is manufactured by Apotex Corp. The aripiprazole market includes numerous generic manufacturers, creating a highly competitive landscape. Key generic competitors include:

• Teva Pharmaceuticals
• Mylan N.V. (now Viatris)
• Sun Pharmaceutical Industries
• Lupin Pharmaceuticals
• Dr. Reddy's Laboratories
• Hikma Pharmaceuticals
• Alembic Pharmaceuticals
• Torrent Pharmaceuticals
• Zydus Lifesciences
• Cipla

The presence of these multiple generic players significantly impacts pricing strategies and market access. Patent expiries for the originator product, Abilify (aripiprazole), have led to widespread generic competition, driving down unit prices.

What are the Primary Therapeutic Indications and Patient Populations for NDC 00378-7308?

NDC 00378-7308, Aripiprazole Oral Solution, is indicated for the treatment of the following conditions:

• Schizophrenia in patients 13 years of age and older [2].
• Bipolar I Disorder: For acute treatment of manic or mixed episodes in patients 12 years of age and older [2]. For maintenance treatment of bipolar I disorder in patients 13 years of age and older [2].
• Adjunctive Treatment of Major Depressive Disorder (MDD) in patients 18 years of age and older, when used with an antidepressant [2].
• Irritability Associated with Autistic Disorder in pediatric patients 6 years of age and older [2].

The oral solution formulation is particularly beneficial for pediatric patients and individuals who have difficulty swallowing pills, expanding its utility across diverse age groups and patient needs. This formulation also allows for more precise dose titration.

What is the Current Pricing Landscape and What Factors Influence It?

The pricing for generic aripiprazole, including NDC 00378-7308, is characterized by intense competition and is subject to significant downward pressure. The average wholesale price (AWP) for aripiprazole oral solution can range from $300 to $600 for a 150 mL bottle (1 mg/mL), depending on the specific distributor, pharmacy, and payer contracts [3].

Key factors influencing pricing include:

• Generic Competition: The high number of generic manufacturers leads to aggressive price undercutting.
• Payer Negotiations: Pharmacy benefit managers (PBMs) and insurance companies negotiate significant rebates and discounts, further reducing net prices.
• Manufacturing Costs: Raw material costs, production scale, and quality control expenses contribute to the base price.
• Regulatory Compliance: Meeting FDA manufacturing standards and quality requirements incurs costs.
• Supply Chain Dynamics: Availability of active pharmaceutical ingredients (APIs) and distribution logistics affect pricing stability.
• Volume Discounts: Larger purchasers typically secure more favorable pricing.

Apotex, as a generic manufacturer, operates within this highly price-sensitive market. Contract sales to institutional providers, such as hospitals and long-term care facilities, often involve further negotiated pricing structures.

What are the Projected Price Trends for NDC 00378-7308?

Price projections for NDC 00378-7308 indicate a trend of continued price stability with potential for slight declines due to ongoing competition and payer pressure.

• Short-term (1-2 years): Prices are expected to remain relatively stable, with minor fluctuations driven by supply and demand. Any significant price erosion would likely result from new market entrants or substantial changes in payer formularies.
• Medium-term (3-5 years): Continued competitive pressure from existing and potentially new generic manufacturers will likely exert a downward influence on prices. However, the cost of API and adherence to stringent manufacturing standards will set a floor.
• Long-term (5+ years): Without the introduction of new formulations or significant shifts in the competitive landscape, prices are likely to stabilize at levels dictated by manufacturing efficiency and the cost of goods sold. The expiration of any remaining market exclusivities for newer aripiprazole formulations could also indirectly impact pricing by increasing overall generic availability.

A typical price erosion curve for a successful generic drug sees a sharp decline post-launch, followed by a period of relative stability as the market matures. Aripiprazole has already undergone this initial phase. Future price movements will be incremental.

Table 1: Aripiprazole Oral Solution (1 mg/mL) Price Projections

Time Horizon	Projected Price Range (per 150mL bottle)	Key Influencing Factors
Current	$300 - $600	High generic competition, payer rebates, manufacturing costs
1-2 Years	$280 - $580	Stable competition, slight downward pressure from payer negotiations
3-5 Years	$270 - $550	Sustained competition, potential for minor price decreases
5+ Years	$260 - $530	Maturation of market, price floor based on cost of goods, stable competition

Note: Prices are estimates for AWP and do not reflect net prices after rebates and discounts.

What Regulatory and Intellectual Property Factors Affect the Market?

The regulatory environment for generic drugs is stringent, impacting development, manufacturing, and market entry.

• FDA Approval: NDC 00378-7308 must meet all FDA requirements for safety, efficacy, and quality. Generic approval requires demonstrating bioequivalence to the reference listed drug (RLD).
• Patent Landscape: The patent landscape for aripiprazole has largely expired, allowing for widespread generic entry. However, ongoing litigation related to secondary patents or specific formulations can occasionally create temporary market uncertainties.
• Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP standards, ensuring consistent product quality and compliance. Any deviation can lead to production halts or product recalls.
• Orphan Drug Exclusivity: While aripiprazole is not typically considered an orphan drug for its primary indications, specific formulations or indications pursued by originator companies can sometimes involve exclusivity periods that impact the broader generic market. This is less relevant for the established generic product.
• ANDA Process: The Abbreviated New Drug Application (ANDA) process allows for the approval of generic versions of approved drugs. The speed and success of an ANDA filing can impact market entry timing for manufacturers.

What are the Risks and Opportunities for Stakeholders?

Risks:

• Intensified Price Competition: The entry of new generic manufacturers or aggressive pricing by existing ones can lead to significant margin compression.
• Payer Policy Changes: Shifts in PBM or insurance company formulary management, prior authorization requirements, or preferred drug lists can impact market access and reimbursement.
• Supply Chain Disruptions: Global supply chain issues, including API shortages or manufacturing delays, can affect product availability and pricing stability.
• Quality and Compliance Issues: FDA scrutiny or manufacturing defects can lead to product recalls, damaging brand reputation and incurring significant financial losses.
• Emergence of Biosimilars (N/A for small molecule drugs): While not applicable to small molecule drugs like aripiprazole, the threat of novel delivery systems or combination therapies from originator companies could indirectly influence long-term market dynamics.

Opportunities:

• Market Penetration in Underserved Geographies: Expansion into emerging markets where generic adoption is increasing.
• Contract Manufacturing: Providing manufacturing services to other pharmaceutical companies requiring aripiprazole API or finished product.
• Optimizing Manufacturing Efficiency: Streamlining production processes to reduce costs and maintain competitive pricing.
• Targeted Market Segments: Focusing on specific patient populations or healthcare settings where the oral solution offers a distinct advantage.
• Long-term Supply Agreements: Securing stable revenue streams through multi-year contracts with large healthcare systems or distributors.

Key Takeaways

NDC 00378-7308, Aripiprazole Oral Solution 1 mg/mL by Apotex Corp., operates in a mature and competitive generic drug market. The product is indicated for schizophrenia, bipolar disorder, MDD adjunctive therapy, and autistic disorder irritability. Pricing is subject to significant downward pressure from multiple generic competitors and payer negotiations. Projections suggest continued price stability with a potential for incremental declines over the next 3-5 years, driven by manufacturing costs and sustained competition. Regulatory compliance and efficient supply chain management are critical for sustained market participation.

FAQs

1. What is the current average net price of NDC 00378-7308 after typical rebates and discounts? Net pricing data is proprietary and varies significantly based on contract terms between manufacturers, distributors, and PBMs. Publicly available AWP figures do not reflect these confidential negotiated rates.

2. Are there any pending patent challenges that could impact the generic aripiprazole market for NDC 00378-7308? The primary patents for aripiprazole have expired. While litigation can occur over secondary patents or manufacturing processes, significant disruptions to the generic market due to patent challenges are unlikely at this stage.

3. How does the oral solution formulation's price compare to aripiprazole tablets? Oral solutions generally command a higher price per unit dose than standard tablets due to the added complexity and cost of formulation, manufacturing, and packaging. However, the total cost of therapy depends on dosage and patient adherence.

4. What is the typical market share of Apotex Corp. within the overall generic aripiprazole market? Specific market share data for individual generic manufacturers is not publicly disclosed. Apotex is a significant player in the generic pharmaceutical space, but its exact share of the aripiprazole market is not determinable from public sources.

5. What are the primary risks associated with the supply chain for aripiprazole API? Risks include reliance on a limited number of API manufacturers, geopolitical instability in sourcing regions, fluctuations in raw material costs, and stringent quality control requirements that can lead to production delays or batch rejections.

Citations

[1] Grand View Research. (2023, August). Aripiprazole Market Size, Share & Trends Analysis Report. [2] U.S. Food & Drug Administration. (2023). Drugs@FDA Database. [3] First Databank, Inc. (2023). National Drug Data File (NDDF) and Medispan Pricing Data. (Proprietary databases accessed via subscription services).