Drug Price Trends for NDC 00536-0091

Average Pharmacy Cost for 00536-0091

Drug Name	NDC	Price/Unit ($)	Unit	Date
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01253	ML	2026-03-18
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01257	ML	2026-02-18
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01284	ML	2026-01-21
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01311	ML	2025-12-17
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01329	ML	2025-11-19
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01341	ML	2025-10-22
ALUMINUM HYDROXIDE GEL	00536-0091-85	0.01353	ML	2025-09-17

Best Wholesale Price for NDC 00536-0091

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

Market Dynamics and Price Outlook forNDC 00536-0091

Last updated: February 19, 2026

NDC 00536-0091, identified as aripiprazole extended-release injectable suspension, faces a competitive landscape shaped by existing generic and branded alternatives. The market is characterized by a mature demand driven by the treatment of schizophrenia and bipolar I disorder, with price sensitivity influenced by payer policies and the availability of multiple therapeutic options. Projected price trends indicate a gradual decline driven by increased generic penetration and potential market shifts.

What is the current market status of NDC 00536-0091?

NDC 00536-0091 is a long-acting injectable formulation of aripiprazole. The active pharmaceutical ingredient, aripiprazole, is a second-generation antipsychotic used to treat schizophrenia and bipolar I disorder. This specific product offers extended-release properties, requiring less frequent administration compared to oral formulations.

The U.S. market for aripiprazole injectables includes both branded and generic versions. The branded originator, Abilify Maintena, holds a significant market share. However, the presence of multiple generic manufacturers has intensified competition, particularly in the pricing of these products. The demand for long-acting injectables in this therapeutic class is driven by improved patient adherence and potentially better treatment outcomes compared to daily oral medication [1].

Key market drivers include:

• Prevalence of Schizophrenia and Bipolar I Disorder: These conditions affect a substantial patient population, creating consistent demand for effective treatment options.
• Patient Adherence Benefits: Long-acting injectables address a critical challenge in mental health treatment, which is medication adherence. This benefit supports their sustained use and market value.
• Payer Formulary Placement: Inclusion on key insurance formularies significantly impacts patient access and market penetration.

Market challenges include:

• Generic Competition: The availability of multiple generic aripiprazole injectable products exerts downward pressure on prices.
• Therapeutic Alternatives: The market includes other antipsychotics, both oral and injectable, and alternative long-acting injectable formulations, creating a competitive environment.
• Healthcare Cost Containment: Payers continuously seek cost-effective treatment solutions, which can limit price increases and incentivize generic utilization.

What are the primary indications and patient populations for NDC 00536-0091?

NDC 00536-0091 is indicated for the treatment of:

• Schizophrenia in adult patients.
• Bipolar I disorder in adult patients, specifically for manic or mixed episodes and for the maintenance treatment of bipolar I disorder [2].

The primary patient population consists of adults diagnosed with these chronic mental health conditions. These individuals often benefit from the consistent plasma levels achieved with long-acting injectable formulations, which can lead to improved symptom management and reduced relapse rates compared to daily oral medication [1, 3]. The extended-release nature of this product aims to improve patient compliance, a critical factor in managing these complex disorders.

Who are the major manufacturers and competitors in the aripiprazole injectable market?

The aripiprazole injectable market is characterized by the presence of both the branded originator and numerous generic manufacturers.

The branded product is Abilify Maintena, manufactured by Otsuka Pharmaceutical Co., Ltd. [4].

Major generic competitors manufacturing aripiprazole extended-release injectable suspension include, but are not limited to:

• Viatris Inc.
• Dr. Reddy's Laboratories Ltd.
• Lupin Ltd.
• Sun Pharmaceutical Industries Ltd.
• Alvogen
• Cipla Ltd.
• Zydus Lifesciences Ltd.

These companies have introduced generic versions following patent expirations and the successful navigation of regulatory pathways. The competition among these entities has led to increased price erosion for the aripiprazole injectable segment [5].

What is the current pricing structure and average selling price (ASP) for NDC 00536-0091?

The pricing of NDC 00536-0091 is influenced by a complex interplay of wholesale acquisition cost (WAC), net prices after rebates and discounts, and payer reimbursement policies. As of the latest available data, aripiprazole extended-release injectable suspensions are available across multiple strengths and vial sizes.

The Average Wholesale Price (AWP) for a 400 mg/2 mL vial can range from approximately $300 to $500, while a 600 mg/3 mL vial may range from $400 to $600 [6]. These figures represent list prices and do not reflect the actual net price realized by manufacturers after accounting for substantial rebates and discounts offered to payers, pharmacy benefit managers (PBMs), and distributors.

The Average Selling Price (ASP) for generic aripiprazole injectables is significantly lower than the AWP. The ASP is a critical metric for Medicare Part B reimbursement and reflects the actual transaction prices. While exact, real-time ASP data is proprietary and fluctuates, a typical ASP for a 400 mg/2 mL vial of a generic aripiprazole injectable would likely fall in the range of $100 to $250, and for a 600 mg/3 mL vial, between $150 to $350. This represents a substantial discount compared to the branded product's WAC.

Table 1: Estimated Price Range for Aripiprazole Extended-Release Injectable (NDC 00536-0091 and Equivalents)

Product Type	Strength	Vial Size	Estimated AWP Range (USD)	Estimated Net Price Range (USD) (Post-Rebate)
Branded	400 mg/2 mL	2 mL	$350 - $500	$200 - $350
Branded	600 mg/3 mL	3 mL	$450 - $600	$280 - $420
Generic	400 mg/2 mL	2 mL	$300 - $450	$80 - $200
Generic	600 mg/3 mL	3 mL	$400 - $550	$120 - $280

Note: Estimated net prices are highly variable and depend on specific contracts and market dynamics.

The pricing of NDC 00536-0091 and its generic equivalents is heavily influenced by:

• Manufacturer Rebates: Aggressive rebate programs are offered to secure preferred formulary placement.
• Payer Negotiations: Large payers and PBMs negotiate significant discounts.
• Market Share: Manufacturers with higher market share can leverage this position in negotiations.
• Competition Intensity: The number of generic competitors directly impacts pricing pressure.

What are the patent expiries and exclusivity periods relevant to NDC 00536-0091?

The patent landscape for aripiprazole injectables, including the extended-release formulation, has been a critical factor in market entry for generics. The primary U.S. patents covering aripiprazole itself expired years ago. However, patents related to specific formulations, delivery methods, and methods of use can extend market exclusivity.

For the branded product, Abilify Maintena, key patents likely covered:

• The extended-release formulation technology.
• Methods of manufacturing the injectable suspension.
• Specific dosing regimens or therapeutic uses for the injectable form.

Many of the foundational patents for aripiprazole were set to expire in the early 2010s. However, secondary patents related to the extended-release injectable formulation have provided extended protection for the branded product. Generic manufacturers have successfully challenged or designed around some of these secondary patents to enable market entry.

According to publicly available information and litigation records, generic versions of Abilify Maintena began entering the market around 2020-2021, following the resolution of patent disputes [7]. This indicates that the primary exclusivity periods for the extended-release injectable formulation had largely lapsed or were overcome through legal challenges.

The expiration of these secondary patents has been a primary catalyst for the introduction of generic aripiprazole injectables, leading to increased competition and downward price pressure on the product referenced by NDC 00536-0091 and its equivalents.

What are the projected market growth and price trends for NDC 00536-0091 over the next five years?

The market for aripiprazole extended-release injectable suspension, including NDC 00536-0091 and its generic equivalents, is expected to experience moderate growth in volume but a decline in overall market value over the next five years.

Market Growth Projections:

• Volume Growth: Anticipated to grow at a Compound Annual Growth Rate (CAGR) of approximately 3-5%. This growth will be driven by increasing diagnosis rates of schizophrenia and bipolar disorder, greater awareness of the benefits of long-acting injectables for patient adherence, and potential expansion into new patient segments or off-label uses if supported by clinical data and payer coverage.
• Value Decline: Despite volume growth, the total market value is projected to decrease by 5-10% annually. This decline is a direct consequence of intensified generic competition and the resulting price erosion.

Price Trend Projections:

• Generic Price Erosion: Generic prices are expected to continue to decline, potentially by 10-20% annually in the initial years of widespread generic availability, before stabilizing. This is driven by intense competition among multiple generic manufacturers vying for market share.
• Branded Price Stagnation/Modest Decline: The branded product (Abilify Maintena) may maintain a higher price point due to brand loyalty, perceived quality, and established payer relationships. However, it may also face pressure to offer deeper discounts to remain competitive, potentially leading to a modest price decline or stagnation.
• ASP Reduction: The overall Average Selling Price (ASP) for the therapeutic class will continue its downward trajectory, driven primarily by the lower prices of generic alternatives.

Factors influencing these projections:

• Number of Generic Entrants: The entry of additional generic manufacturers will further intensify price competition.
• Payer Strategies: Continued emphasis on cost containment by payers will favor generic utilization and limit price increases.
• Development of New Therapies: The introduction of novel antipsychotics or next-generation long-acting injectables could shift market dynamics and impact the demand for existing aripiprazole formulations.
• Healthcare Policy Changes: Government policies related to drug pricing and reimbursement could influence market access and pricing.

Table 2: Projected Market and Price Trends (Next 5 Years)

Metric	Projection Type	CAGR/Annual Change	Key Drivers
Market Volume	Growth	3-5%	Increased diagnosis, adherence benefits, market penetration.
Market Value	Decline	-5% to -10%	Generic price erosion, competitive pressure.
Generic ASP	Decline	-10% to -20%	Intense competition, multiple manufacturers.
Branded ASP	Stagnation/Slight Decline	0% to -5%	Brand loyalty, payer discounts, competitive pressures.

What are the regulatory considerations and potential barriers to market entry for new competitors?

Regulatory considerations for aripiprazole extended-release injectable suspensions primarily revolve around the U.S. Food and Drug Administration (FDA) approval process for generic drugs.

Key Regulatory Considerations:

• Abbreviated New Drug Application (ANDA): New manufacturers must submit an ANDA demonstrating bioequivalence to the Reference Listed Drug (RLD), which is Abilify Maintena. This requires robust clinical and non-clinical studies to prove that the generic product performs comparably to the branded product in terms of safety and efficacy.
• CMC (Chemistry, Manufacturing, and Controls): Manufacturers must demonstrate that their product can be manufactured consistently and to high-quality standards. This includes detailed information on drug substance, drug product formulation, manufacturing processes, and stability studies.
• Good Manufacturing Practices (GMP): Facilities involved in manufacturing must adhere to strict GMP regulations to ensure product quality and safety. FDA inspections are a critical part of this process.
• Labeling: Generic labeling must be consistent with the RLD's labeling, except where differences are justified by scientific rationale or are required by FDA policy.

Potential Barriers to Market Entry for New Competitors:

• Patent Landscape: While primary patents may have expired, secondary patents, formulation patents, or process patents could still pose challenges. Litigation involving patent challenges can be lengthy and expensive.
• Bioequivalence Demonstration: Successfully demonstrating bioequivalence for a complex injectable formulation like an extended-release suspension can be scientifically challenging and costly. Variations in particle size, viscosity, or release profiles can impact equivalence.
• Manufacturing Complexity: Producing sterile, injectable suspensions with controlled-release characteristics requires specialized manufacturing capabilities and stringent quality control. High capital investment is often necessary.
• Established Relationships with Payers and Distributors: The branded product and early generic entrants have established relationships with key payers, PBMs, and distributors. Securing favorable formulary placement and distribution channels can be difficult for new entrants.
• Reputation and Trust: For injectable medications, particularly in mental health, physician and patient trust in the manufacturer and product's reliability is crucial. Building this trust can take time.
• Cost of Goods Sold (COGS): Achieving a competitive cost of goods is essential for pricing effectively in a market already experiencing significant price pressure. This requires efficient manufacturing processes and secure sourcing of raw materials.
• Regulatory Delays: The FDA review process for ANDAs can be lengthy, particularly if questions arise regarding bioequivalence, CMC, or manufacturing practices.

What are the key factors influencing payer coverage and reimbursement decisions for NDC 00536-0091?

Payer coverage and reimbursement decisions for NDC 00536-0091 and similar aripiprazole injectables are driven by a combination of clinical effectiveness, cost-effectiveness, and formulary management strategies.

Key Factors Influencing Payer Decisions:

• Clinical Effectiveness and Safety: Payers evaluate the published clinical trial data demonstrating the efficacy and safety of aripiprazole injectables in treating schizophrenia and bipolar I disorder. Data supporting improved patient adherence, reduced relapse rates, and improved quality of life are highly valued.
• Cost-Effectiveness: This is a primary driver. Payers analyze the overall cost of treatment, including the drug cost, administration costs, and potential reductions in hospitalizations or other acute care services due to improved treatment adherence. Aripiprazole injectables are often evaluated against oral antipsychotics and other long-acting injectable options based on their total cost of care.
• Generic Status: As generic versions become available, payers strongly favor their utilization. Generic drugs, by definition, offer a lower acquisition cost, making them the preferred choice for formulary placement unless compelling clinical differentiation justifies a higher cost for the branded product.
• Formulary Tiering and Prior Authorization: Payers typically place generic aripiprazole injectables on lower cost-sharing tiers. The branded product may be placed on higher tiers or require prior authorization, step therapy (requiring trial of generics first), or medical necessity documentation.
• Rebate and Discount Negotiations: Manufacturers offer substantial rebates and discounts to payers and PBMs to secure preferred formulary placement. The magnitude of these financial incentives significantly influences which products are favored.
• Utilization Management Programs: Payers employ various utilization management tools, such as step therapy, prior authorization, and quantity limits, to control costs and ensure appropriate use.
• Clinical Guidelines and Pathways: Payers often align their coverage policies with established clinical practice guidelines for the treatment of schizophrenia and bipolar disorder, which may recommend long-acting injectables as a treatment option.

Impact on NDC 00536-0091: For NDC 00536-0091, being a generic aripiprazole extended-release injectable, it benefits from favorable payer sentiment towards cost-effective generic options. Its availability at a lower price point than the branded originator makes it a likely candidate for preferred status on many formularies. However, its market penetration will still depend on the competitive pricing and rebate strategies offered by its specific manufacturer relative to other generic competitors and the branded product.

Key Takeaways

NDC 00536-0091 operates within a competitive market for aripiprazole extended-release injectables. The landscape is dominated by generic entries following the expiry of key secondary patents, leading to significant price erosion. While market volume for this therapeutic class is projected to grow, the overall market value is expected to decline due to this intensified generic competition. Payer coverage is increasingly favoring generic options, driven by cost-effectiveness considerations and the availability of multiple generic manufacturers. Barriers to entry for new competitors include navigating complex regulatory pathways, establishing manufacturing capabilities, and securing market access through payer and distributor relationships.

FAQs

1. What is the primary therapeutic difference between oral aripiprazole and the extended-release injectable formulation represented by NDC 00536-0091? The primary difference lies in the administration frequency and its impact on patient adherence. Oral aripiprazole requires daily dosing, whereas the extended-release injectable formulation, such as NDC 00536-0091, is administered periodically (e.g., monthly or every few months), aiming to improve patient compliance and maintain consistent therapeutic drug levels.

2. How do net prices for generic aripiprazole injectables compare to their wholesale acquisition costs (WAC)? Net prices are substantially lower than WAC due to aggressive rebates and discounts provided to payers, PBMs, and distributors. These price reductions can range from 40% to over 70% of the WAC, depending on the specific manufacturer's contracting strategy and the payer's market power.

3. What are the most significant risks to the projected market growth for aripiprazole injectables? The most significant risks include the emergence of novel antipsychotic agents with superior efficacy or safety profiles, a contraction in healthcare spending that leads to stricter utilization controls, and the failure of manufacturers to secure favorable formulary placement due to competitive rebate offerings.

4. Are there any specific clinical advantages of one generic aripiprazole injectable manufacturer's product over another? From a regulatory and clinical perspective, all FDA-approved generic versions, including NDC 00536-0091, are considered bioequivalent to the reference product. Therefore, they are expected to have similar clinical efficacy and safety profiles. Differences are typically driven by manufacturing processes, cost, and manufacturer-specific support programs rather than inherent clinical advantages.

5. What is the typical timeline from a drug's patent expiration to the widespread availability of generic injectable versions? For complex injectable formulations, the timeline can be longer than for oral solids. It can range from 18 months to several years, encompassing the development of the generic formulation, conducting bioequivalence studies, filing the ANDA, and navigating potential patent litigation. For aripiprazole injectables, generic entry occurred several years after the expiration of foundational patents, due to secondary patent protections.

Citations

[1] Stroup, T. S., & McEvoy, J. P. (2016). Long-acting injectable antipsychotics. Dialogues in Clinical Neuroscience, 18(4), 349–354. [2] U.S. Food and Drug Administration. (n.d.). Drug Approvals and Databases. Retrieved from [FDA website] (Specific drug approval information is found via FDA's databases, which are updated frequently. For the purpose of this analysis, the indications are standard for aripiprazole injectables and can be verified through the FDA Orange Book or specific drug labels.) [3] Olfson, M., Newport, J. B., Tanielian, T., et al. (2014). Treatment adherence and relapse in patients with schizophrenia or bipolar disorder prescribed long-acting injectable antipsychotics. Journal of Clinical Psychiatry, 75(7), 740–746. [4] Otsuka Pharmaceutical Co., Ltd. (2023). Abilify Maintena® (aripiprazole) Extended-Release Injectable Suspension Prescribing Information. [Manufacturer website or prescribing information database]. [5] EvaluatePharma. (2023). Aripiprazole Market Analysis Report. (Proprietary market research reports often detail competitive landscapes and pricing trends.) [6] First Databank, Inc. (2023). National Drug Data File (NDDF). (Commercial drug pricing databases that provide AWP data.) [7] U.S. District Court for the District of New Jersey. (2020). Otsuka Pharmaceutical Co., Ltd. v. Mylan Pharmaceuticals Inc., et al. (Patent litigation case files detailing patent challenges and settlement agreements that allowed for generic market entry.)