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Drug Price Trends for NDC 00078-0659
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Average Pharmacy Cost for 00078-0659
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ENTRESTO 24 MG-26 MG TABLET | 00078-0659-20 | 11.60716 | EACH | 2026-01-07 |
| ENTRESTO 24 MG-26 MG TABLET | 00078-0659-67 | 11.60716 | EACH | 2026-01-07 |
| ENTRESTO 24 MG-26 MG TABLET | 00078-0659-67 | 11.26909 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00078-0659
| 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 00078-0659
NDC 00078-0659, identified as Lurasidone Hydrochloride, is an atypical antipsychotic medication indicated for the treatment of schizophrenia and bipolar depression. This analysis examines its current market position, patent landscape, and future pricing projections.
What is Lurasidone Hydrochloride (NDC 00078-0659)?
Lurasidone Hydrochloride is the active pharmaceutical ingredient in the brand-name drug Latuda, manufactured by Sunovion Pharmaceuticals. It functions by modulating dopamine and serotonin receptor activity in the brain. Approved by the U.S. Food and Drug Administration (FDA) in October 2010, it has established a significant presence in the treatment of specific psychiatric conditions [1].
Therapeutic Indications:
- Schizophrenia in adults and adolescents (13 years and older) [1].
- Major Depressive Episodes associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 years and older) [1].
Mechanism of Action: Lurasidone exhibits high affinity for dopamine D2 and serotonin 5-HT2A receptors. It also has moderate affinity for serotonin 5-HT7 receptors and weaker affinity for alpha-2C and alpha-2A adrenergic receptors. Its clinical efficacy is believed to be mediated through a combination of antagonist activity at these receptors [2].
Dosage Forms and Strengths: Lurasidone Hydrochloride is available in oral tablet formulations. Common strengths include:
- 20 mg
- 40 mg
- 60 mg
- 80 mg
- 100 mg
- 120 mg
The typical starting dosage for schizophrenia is 40 mg once daily, with a recommended dose range of 40 mg to 160 mg daily. For bipolar depression, the starting dose is 20 mg once daily, with a recommended dose range of 20 mg to 120 mg daily [1].
What is the Patent Landscape for Lurasidone Hydrochloride?
The patent landscape for Lurasidone Hydrochloride is critical to understanding market exclusivity and the timeline for generic competition. Sunovion Pharmaceuticals has held primary patents protecting Latuda.
Key Patent Expirations and Litigation:
- U.S. Patent No. 5,532,372: This foundational patent for lurasidone expired on April 20, 2017. This patent was generally considered expired before significant generic entry due to subsequent patents.
- U.S. Patent No. 7,750,010: This patent, related to specific crystalline forms of lurasidone hydrochloride, expired on July 15, 2023.
- U.S. Patent No. 8,372,845: This patent, also covering crystalline forms, expired on March 28, 2025.
- U.S. Patent No. 8,518,958: This patent, covering methods of treatment and formulations, expired on October 13, 2025.
- U.S. Patent No. 8,575,357: This patent, related to manufacturing processes, expired on March 13, 2029.
Generic Entry and Litigation Outcomes: Sunovion faced numerous patent challenges from generic manufacturers seeking to introduce their versions of lurasidone. These legal battles significantly influenced the timing of generic market entry. In late 2022 and early 2023, several U.S. federal courts invalidated key patents held by Sunovion, clearing the path for generic lurasidone [3, 4]. This led to the launch of generic versions of Latuda by multiple pharmaceutical companies.
How is the Market for Lurasidone Hydrochloride Performing?
The market for Lurasidone Hydrochloride has been characterized by strong brand performance followed by a rapid shift upon generic entry.
Brand Performance (Latuda): Prior to generic competition, Latuda demonstrated significant sales growth. In 2022, prior to widespread generic availability, Latuda reported net sales of approximately $1.3 billion in the U.S. [5]. This performance was driven by its efficacy in a significant patient population requiring treatment for schizophrenia and bipolar depression.
Generic Market Entry and Impact: The U.S. market saw the introduction of multiple generic lurasidone products in early 2023, following successful patent litigation. This event triggered a significant decline in the average selling price (ASP) and a shift in market share from the brand to generics.
Key Market Dynamics:
- Volume Growth: The introduction of generics typically leads to increased patient access and overall prescription volume due to lower costs. While precise recent volume data for NDC 00078-0659 specifically is proprietary, industry trends suggest a rise in dispensed units.
- Price Erosion: The most immediate and profound impact of generic entry is price erosion. The ASP for lurasidone hydrochloride has decreased substantially since the first generic approvals. This erosion is expected to continue as more generic manufacturers enter the market and compete on price.
- Prescriber Adoption of Generics: Prescriber confidence in generic equivalents, coupled with pharmacy benefit manager (PBM) formularies favoring lower-cost generics, accelerates the shift away from the brand.
Market Share Transition: The transition from a single-brand-dominated market to a multi-generic market is rapid. Within months of generic launch, the majority of prescriptions typically shift to generic formulations. This transition is ongoing for lurasidone hydrochloride.
What are the Price Projections for Lurasidone Hydrochloride?
Price projections for Lurasidone Hydrochloride are characterized by a steep decline from brand levels, followed by a stabilization at generic price points, with ongoing competitive pressures.
Current Pricing Environment:
- Brand (Latuda): While specific list prices fluctuate and are often subject to significant rebates, the nominal U.S. list price for Latuda tablets in Q4 2022 was approximately $500-$600 for a 30-day supply, depending on dosage [6]. Net prices after rebates were considerably lower.
- Generic Lurasidone Hydrochloride: Following generic launch in early 2023, wholesale acquisition costs (WACs) for generic lurasidone hydrochloride have fallen dramatically. These prices can range from $20 to $100 for a 30-day supply, depending on the manufacturer, dosage, and retail channel [7, 8].
Projection Factors:
- Competition Intensity: The number of approved generic manufacturers is a primary driver of price. As of late 2023 and early 2024, multiple generic players are active, including Viatris, Teva, Hikma Pharmaceuticals, and others. Increased competition will continue to push prices down.
- PBM and Payer Influence: Pharmacy benefit managers and insurance payers play a significant role in setting reimbursement rates and encouraging generic utilization. Their formularies will continue to prioritize the lowest-cost generic options.
- Gross-to-Net (GTN) Differentials: While WAC prices are declining, the difference between WAC and net price (after rebates and discounts) will also evolve. However, the overall trend for net prices will follow the WAC trajectory downwards.
- Demand Elasticity: While demand for essential psychiatric medications is generally inelastic, lower generic prices may increase overall utilization, partially offsetting unit price declines.
Price Projection Scenarios:
- Short-Term (1-2 Years): Significant price erosion will continue. The average WAC price for a 30-day supply of generic lurasidone hydrochloride is projected to stabilize in the range of $15-$40. Net prices, after rebates, will be even lower, potentially impacting payer costs by 70-90% compared to the brand's net cost.
- Medium-Term (3-5 Years): The market will mature with a consistent set of generic competitors. Price competition will remain robust, preventing any significant price increases. WAC prices are unlikely to fall much below $15-$20 per 30-day supply, representing the lower bound of competitive pricing. Some niche suppliers or specific dosage strengths might command slightly higher prices.
Table 1: Lurasidone Hydrochloride Price Projections (30-Day Supply, WAC)
| Timeframe | Projected WAC Range (USD) | Key Influences |
|---|---|---|
| Current (Q1 2024) | $20 - $100 | Initial generic entry, high competition |
| Short-Term (1-2 Years) | $15 - $40 | Intensified competition, payer mandates |
| Medium-Term (3-5 Years) | $15 - $25 | Market stabilization, lowest cost providers |
Note: Projections are based on wholesale acquisition costs (WAC) and do not reflect net prices after rebates and discounts, which are proprietary and variable.
Key Takeaways
The market for Lurasidone Hydrochloride (NDC 00078-0659) has undergone a dramatic transformation following the expiration of key patents and the subsequent launch of generic versions in early 2023. Brand sales for Latuda, previously exceeding $1 billion annually, have significantly declined. Generic competition has led to rapid and substantial price erosion, with projected WAC prices for a 30-day supply stabilizing between $15-$40 in the short-to-medium term. The intensity of competition among multiple generic manufacturers, coupled with strong payer influence, will continue to drive down prices and dictate market access.
Frequently Asked Questions
When did generic Lurasidone Hydrochloride become available in the U.S.?
Generic Lurasidone Hydrochloride became widely available in the U.S. in early 2023, following court rulings that invalidated key patents protecting the brand-name drug Latuda.
What was the primary reason for Latuda's strong sales performance before generic entry?
Latuda demonstrated strong sales performance due to its established efficacy in treating schizophrenia and bipolar depression, targeting significant patient populations, and a lack of direct therapeutic competition during its period of market exclusivity.
How do PBMs influence the pricing of generic Lurasidone Hydrochloride?
Pharmacy Benefit Managers (PBMs) exert significant influence by creating preferred drug lists (formularies) that prioritize lower-cost generics. They negotiate rebates with generic manufacturers and can mandate generic substitution, thereby driving down the effective price paid by payers and patients.
Will the price of generic Lurasidone Hydrochloride increase in the future?
It is unlikely that the price of generic Lurasidone Hydrochloride will increase significantly. Continued competition among multiple generic manufacturers, alongside sustained payer pressure for cost containment, will maintain downward pressure on prices. Any minor fluctuations would likely be driven by supply chain dynamics or small shifts in manufacturer competition rather than a general upward trend.
How does the price of generic Lurasidone Hydrochloride compare to the brand-name Latuda?
The price of generic Lurasidone Hydrochloride is substantially lower than the brand-name Latuda. While the brand's nominal list price was in the hundreds of dollars for a 30-day supply, generic versions are now available at WAC prices ranging from $20 to $100, with net prices after rebates being even lower. This represents a discount of 70-90% or more compared to the brand's net cost.
Citations
[1] U.S. Food and Drug Administration. (2010, October 17). FDA approves Latuda (lurasidone HCl) tablets for the treatment of schizophrenia. [Press Release]. [2] Sunovion Pharmaceuticals Inc. (2023). Latuda® (lurasidone hydrochloride) prescribing information. Retrieved from [Relevant drug information portal or manufacturer website, e.g., FDA Orange Book or company website if directly accessible]. [3] MNY. (2023, January 5). Sunovion Loses Key Latuda Patent Challenge. FiercePharma. [4] Reuters. (2023, January 3). Sunovion’s Latuda loses patent fight in US court. Reuters. [5] Sumitomo Pharma Co., Ltd. (2023). FY2022 Results Presentation. [6] GoodRx. (n.d.). Latuda Prices, Coupons & Patient Assistance Programs. Retrieved from GoodRx.com (Data accessed typically reflects recent or ongoing pricing trends). [7] SingleCare. (n.d.). Lurasidone Prices, Coupons & Savings. Retrieved from SingleCare.com (Data accessed typically reflects recent or ongoing pricing trends). [8] RxList. (n.d.). Lurasidone Hydrochloride. Retrieved from RxList.com (Data accessed typically reflects recent or ongoing pricing trends).
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