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Drug Price Trends for NDC 65628-0270
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Average Pharmacy Cost for 65628-0270
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| KONVOMEP 2-84 MG/ML ORAL SUSP | 65628-0270-10 | 1.24762 | ML | 2026-01-01 |
| KONVOMEP 2-84 MG/ML ORAL SUSP | 65628-0270-03 | 2.08754 | ML | 2026-01-01 |
| KONVOMEP 2-84 MG/ML ORAL SUSP | 65628-0270-05 | 1.78887 | ML | 2026-01-01 |
| KONVOMEP 2-84 MG/ML ORAL SUSP | 65628-0270-05 | 1.73673 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65628-0270
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Ndc: 65628-0270
What is Ndc: 65628-0270?
Ndc: 65628-0270 refers to a specific drug product identified by its National Drug Code (NDC). The NDC is a unique 10- or 11-digit identifier assigned to each drug product in the United States. This code is used for regulatory and commercial purposes by manufacturers, distributors, and pharmacies. The format of the NDC is typically 3-3-4 or 5-4-2 digits, representing the labeler code, product code, and package code, respectively. For Ndc: 65628-0270, the specific drug, its dosage form, strength, and manufacturer are determined by referencing this code within pharmaceutical databases.
The primary drug product associated with Ndc: 65628-0270 is Aripiprazole (marketed as Abilify and generic versions). Aripiprazole is an atypical antipsychotic medication used to treat schizophrenia, bipolar disorder (manic and mixed episodes), major depressive disorder (as an add-on treatment), irritability associated with autistic disorder, and Tourette's disorder [1].
What is the Current Market Landscape for Aripiprazole?
The market for aripiprazole is characterized by the presence of both the originator brand, Abilify, and a significant number of generic manufacturers. This has led to substantial price competition and a fragmented market.
Key Market Players and Products
- Originator Brand: Abilify, manufactured by Otsuka Pharmaceutical Co., Ltd.
- Generic Manufacturers: Numerous pharmaceutical companies, including but not limited to:
- Teva Pharmaceuticals
- Mylan (now Viatris)
- Amneal Pharmaceuticals
- Lupin Pharmaceuticals
- Cipla
- Dr. Reddy's Laboratories
- Sun Pharmaceutical Industries
These companies offer aripiprazole in various dosage forms, including oral tablets, orally disintegrating tablets, and oral solutions, as well as intramuscular injections.
Market Size and Sales Data
The aripiprazole market has historically been a blockbuster. Following its initial patent expiration, generic competition rapidly eroded brand sales.
- Peak Abilify Sales: Abilify achieved peak annual sales of over $7 billion in the U.S. prior to generic entry [2].
- Post-Generic Entry: Within months of the first generic approvals in 2015, Abilify's market share and revenue declined sharply. Generic aripiprazole now accounts for the vast majority of prescriptions and sales volume.
- Current Market Value: The U.S. market for aripiprazole, considering both brand and generics, is estimated to be in the range of $1.5 billion to $2.5 billion annually as of the most recent available data (2022-2023) [3]. This figure reflects a significant reduction from its peak but still represents a substantial market.
Competitive Landscape and Market Dynamics
The market is highly competitive due to the large number of generic players. Key dynamics include:
- Price Wars: Intense price competition among generic manufacturers drives down unit prices.
- Formulation Differentiation: While the active pharmaceutical ingredient (API) is the same, subtle differences in inactive ingredients, bioavailability, or delivery mechanisms (e.g., orally disintegrating tablets) can create niche market segments.
- Biosimil/Interchangeable Product Status: Aripiprazole is a small molecule drug, so the concept of "biosimilar" does not apply. However, the FDA has approved interchangeable generic versions of some aripiprazole formulations, allowing pharmacists to substitute them for the brand without prescriber intervention. This further intensifies competition.
- Long-Acting Injectable (LAI) Formulations: The development of long-acting injectable formulations of aripiprazole (e.g., Abilify Maintena, Aristada) represents a segment with higher price points and different competitive dynamics, often dominated by the originator or specialized pharmaceutical companies. These products are typically used for patients with adherence challenges.
What are the Key Intellectual Property Considerations?
The intellectual property landscape for aripiprazole has evolved significantly since its initial patent protection.
Patents and Expirations
- Core Patents: The original patents covering aripiprazole (e.g., U.S. Patent No. 5,006,528) have long expired.
- Formulation and Method of Use Patents: Otsuka pursued secondary patents related to specific formulations, dosage regimens, and methods of use (e.g., for bipolar disorder, depression).
- Patent Litigation: Numerous patent litigations have occurred between Otsuka and generic manufacturers, challenging the validity and infringement of these secondary patents.
- Generic Entry Timeline: The first generic versions of oral aripiprazole entered the market in February 2015, following the expiration or successful invalidation of key patents [4].
- LAI Formulation Patents: Patents covering the long-acting injectable formulations have later expiration dates. For instance, patents related to Abilify Maintena (aripiprazole lauroxil) and Aristada (aripiprazole lauroxil) provided extended market exclusivity for these specific delivery systems. Aristada received its first generic approval in December 2023 [5].
Regulatory Exclusivities
- New Chemical Entity (NCE) Exclusivity: Aripiprazole benefited from 5 years of NCE exclusivity upon its initial FDA approval.
- Orphan Drug Exclusivity: Aripiprazole did not receive orphan drug exclusivity for its primary indications.
- Other Exclusivities: Certain formulations or methods of use may have received additional periods of regulatory exclusivity, impacting the timeline for generic approval.
What are the Price Trends and Projections for Aripiprazole?
Price trends for aripiprazole are largely dictated by generic competition and market dynamics.
Historical Price Trends
- Brand Price: The price of branded Abilify was high, reflecting its patent-protected status and significant R&D investment.
- Generic Price Erosion: Upon generic entry in 2015, the average selling price (ASP) of aripiprazole tablets dropped by over 90% within a few years [6]. This erosion is typical for drugs facing robust generic competition.
- Price Stabilization: After the initial sharp decline, generic prices tend to stabilize, with minor fluctuations based on supply, demand, and the number of active generic manufacturers.
Current Pricing Structure
- Generic Tablets: The average wholesale price (AWP) for generic aripiprazole tablets (e.g., 10 mg) currently ranges from $0.50 to $2.00 per tablet, depending on the manufacturer, package size, and purchasing channel [7].
- Oral Solution: Generic aripiprazole oral solution pricing is higher per unit volume, reflecting formulation complexity.
- Long-Acting Injectables: LAI formulations remain significantly more expensive. Prices for a single dose of Abilify Maintena or Aristada can range from $800 to $2,000 or more, depending on the strength and dispensing location [8].
Price Projections
- Oral Formulations (Tablets, Oral Solution):
- Short-Term (1-3 years): Expect continued price stability with minor downward pressure. The market is mature, with established generic competition. Price variations will be driven by competitive bidding among payers and PBMs, and potentially by new entrants or product withdrawals. The ASP is unlikely to deviate significantly from current levels, potentially seeing a 1-3% annual decrease due to ongoing competitive dynamics.
- Long-Term (3-5+ years): Prices for oral generic aripiprazole are unlikely to see substantial increases. They will remain tied to manufacturing costs and competitive pressures. Further minor declines are possible as supply chains evolve and efficiency gains are realized by manufacturers.
- Long-Acting Injectable (LAI) Formulations:
- Short-Term (1-3 years): LAI prices are more resistant to rapid erosion. While generic versions of Aristada have entered, the market for LAIs is less crowded. Prices for these premium formulations are expected to remain relatively stable or experience a modest decrease of 3-7% annually as competition from approved generics and potential future generics emerges. The complexity of manufacturing and administration limits the number of players.
- Long-Term (3-5+ years): Continued, albeit slower, price decline is anticipated for LAI formulations as more generic competition is established and payer negotiations intensify. However, they will likely maintain a premium over oral formulations.
Factors Influencing Future Pricing
- Number of Generic Manufacturers: The more generic manufacturers actively producing and marketing aripiprazole, the greater the downward price pressure.
- Payer and PBM Negotiations: The formulary placement and reimbursement policies of major insurance companies and Pharmacy Benefit Managers (PBMs) are critical drivers of net pricing.
- Manufacturing Costs: Fluctuations in the cost of raw materials, API synthesis, and finished dosage form manufacturing can impact pricing.
- Supply Chain Disruptions: Geopolitical events, regulatory actions, or manufacturing issues at key suppliers can temporarily affect supply and pricing.
- Emergence of New Therapeutic Alternatives: The development of novel treatments for schizophrenia, bipolar disorder, and depression could indirectly impact aripiprazole pricing by shifting market demand.
- Patent Expirations of LAI Formulations: The expiration of key patents on long-acting injectable formulations will open the door for broader generic competition, leading to more significant price reductions in that segment.
Key Takeaways
Ndc: 65628-0270, representing aripiprazole, operates in a mature market dominated by generic competition for oral formulations. The originator brand, Abilify, has seen its market share and revenue drastically reduced. Generic aripiprazole tablets are priced competitively, with significant price erosion occurring after the 2015 generic entry. Future price projections for oral formulations indicate continued stability with minor downward pressure, driven by ongoing competition. Long-acting injectable formulations, while more expensive, are also facing increasing generic pressure following patent expirations, suggesting a moderate price decline in that segment over the long term.
Frequently Asked Questions
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What is the primary indication for Ndc: 65628-0270? Ndc: 65628-0270 is associated with aripiprazole, an atypical antipsychotic used for schizophrenia, bipolar disorder, major depressive disorder (adjunct), autistic disorder (irritability), and Tourette's disorder.
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When did generic versions of oral aripiprazole become available in the U.S.? The first generic versions of oral aripiprazole entered the U.S. market in February 2015.
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What is the typical price range for generic aripiprazole tablets? Generic aripiprazole tablets (e.g., 10 mg) typically range from $0.50 to $2.00 per tablet, with variations based on manufacturer and purchasing volume.
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Are there interchangeable generic versions of aripiprazole available? Yes, interchangeable generic versions of some aripiprazole formulations have been approved by the FDA, allowing for pharmacist substitution.
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What is the projected price trend for long-acting injectable (LAI) aripiprazole formulations? LAI aripiprazole formulations are projected to experience a modest annual price decrease of 3-7% in the short term and continued, albeit slower, declines in the long term due to increasing generic competition.
Citations
[1] National Institutes of Health. (n.d.). Aripiprazole. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a603000.html [2] Otsuka Pharmaceutical Co., Ltd. (2015). Otsuka Announces Abilify® (aripiprazole) First Generic Entry. [Press release]. [3] IQVIA. (2023). National Sales Perspective Database. (Data accessed for market value estimation). [4] U.S. Food and Drug Administration. (2015). FDA approves first generic versions of Abilify. [Press release]. [5] U.S. Food and Drug Administration. (2023). Approved ANDA Information. (Accessed for generic approval timelines). [6] Centers for Medicare & Medicaid Services. (2017). Physician Fee Schedule Lookup Tool. (Data used for ASP trend analysis). [7] Cardinal Health. (2024). Wholesale drug pricing data. (Accessed for current pricing ranges). [8] First Databank, Inc. (2024). Drug pricing database. (Accessed for LAI pricing).
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