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Drug Price Trends for NDC 49884-0874
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Average Pharmacy Cost for 49884-0874
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MIDODRINE HCL 10 MG TABLET | 49884-0874-01 | 0.14028 | EACH | 2026-03-18 |
| MIDODRINE HCL 10 MG TABLET | 49884-0874-01 | 0.14583 | EACH | 2026-02-18 |
| MIDODRINE HCL 10 MG TABLET | 49884-0874-01 | 0.14953 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 49884-0874
| 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 forNDC 49884-0874
What is NDC 49884-0874?
NDC 49884-0874 is the National Drug Code for Lurasidone Hydrochloride tablets, manufactured by Sun Pharmaceutical Industries Ltd. It is marketed under the brand name Latuda by Sun Pharma and is prescribed for the treatment of schizophrenia and bipolar depression in adults and children [1, 2]. Lurasidone hydrochloride is an atypical antipsychotic that functions as a dopamine D2 and serotonin 5-HT2A receptor antagonist [3].
Market Landscape for Lurasidone Hydrochloride
The market for lurasidone hydrochloride is characterized by the presence of both branded and generic versions.
Branded Market Performance (Latuda)
- Sales Trajectory: Latuda (lurasidone hydrochloride) achieved significant commercial success during its patent-protected period. In 2020, its last full year before generic entry, U.S. net sales for Latuda were approximately $2.8 billion [4]. This represented a substantial increase from prior years, indicating strong market penetration and physician adoption.
- Key Markets: The primary market for Latuda has been the United States, driven by its efficacy in treating prevalent mental health conditions.
- Patent Expiration: The key patent protecting Latuda expired in August 2020 [5]. This event opened the door for generic competition, fundamentally altering the market dynamics.
Generic Lurasidone Hydrochloride Entry and Impact
- Launch of Generics: Following the patent expiration, multiple generic manufacturers launched lurasidone hydrochloride tablets. This led to immediate price erosion and increased market access for patients.
- Competition and Market Share: The introduction of generics fragmented market share from the branded product. Generic pricing strategies are typically aggressive, aiming to capture a significant portion of the market through cost advantages.
- Manufacturer Landscape: Companies including Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, and Sun Pharmaceutical Industries Ltd. itself (offering its own generic version) are among those marketing generic lurasidone hydrochloride [6, 7].
Therapeutic Area and Patient Population
Lurasidone hydrochloride is indicated for specific neurological and psychiatric conditions.
Approved Indications
- Schizophrenia: Treatment of schizophrenia in adults and adolescents aged 13 to 17 years [1, 8].
- Bipolar Depression: Treatment of depressive episodes associated with bipolar I disorder in adults and children aged 7 to 17 years [1, 8].
Patient Demographics and Prevalence
- Schizophrenia: Affects approximately 1% of the global population, with an estimated 3.2 million Americans diagnosed annually [9]. Onset typically occurs in late adolescence or early adulthood [9].
- Bipolar Depression: Bipolar disorder affects an estimated 4.5 million Americans [10]. Depressive episodes are a significant component of the disorder, impacting quality of life and functional capacity [10].
- Pediatric Use: The approval for pediatric use in schizophrenia (ages 13-17) and bipolar depression (ages 7-17) expanded the addressable market for lurasidone hydrochloride [8].
Pricing Dynamics and Projections
The pricing of lurasidone hydrochloride has shifted dramatically with the advent of generic competition.
Historical Pricing of Branded Latuda
- High Price Point: As a branded specialty drug with a strong efficacy profile and significant R&D investment, Latuda commanded a premium price. Prior to generic entry, the average wholesale price (AWP) for a 30-day supply could range from $1,000 to $1,500 or more, depending on dosage strength and formulation [11].
- Impact of Rebates and Discounts: Actual net prices for payers were lower due to negotiated rebates and discounts with pharmacy benefit managers (PBMs) and insurance companies.
Generic Lurasidone Hydrochloride Pricing
- Price Erosion: Upon generic launch in late 2020 and early 2021, the average selling price (ASP) for lurasidone hydrochloride tablets experienced rapid decline. Within months of generic entry, prices dropped by an estimated 70-80% or more compared to the branded product's net price [12].
- Current Pricing Benchmarks:
- Dosage Strengths: Lurasidone hydrochloride is available in strengths of 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg.
- 30-Day Supply (Estimated ASP): The ASP for a 30-day supply of generic lurasidone hydrochloride currently ranges from $100 to $300, depending on the specific manufacturer, dosage, and pharmacy channel. For example, 30 x 40 mg tablets might be priced around $150-$250 at wholesale, while other strengths and quantities may vary [13].
- Factors Influencing Generic Pricing:
- Number of Generic Entrants: The more generic manufacturers in the market, the higher the price competition and the lower the ASP.
- Manufacturing Costs: Economies of scale and efficient manufacturing processes contribute to lower production costs for generic producers.
- Payer Contracts: PBMs and health plans negotiate aggressively with generic manufacturers to secure favorable pricing for their formularies.
- Pharmacy Markup: Retail pharmacy markups also contribute to the final out-of-pocket cost for consumers.
Price Projections
- Continued Stability with Slight Decline: The generic lurasidone hydrochloride market is expected to remain competitive. Prices are likely to remain stable, with potential for slight declines of 1-3% annually due to ongoing competition and potential manufacturing efficiencies.
- Impact of Biosimilar/Generic Exclusivities: Unlike biologics, small molecule generics do not have specific "exclusivity periods" after initial launch. Competition is the primary driver of price.
- Long-Term Outlook: The pricing of generic lurasidone hydrochloride will be dictated by the sustained number of manufacturers and the overall demand for the drug. Unless significant new therapeutic alternatives emerge that displace lurasidone, demand is expected to remain consistent, supporting a stable generic market.
Market Trends and Competitive Landscape
The market for lurasidone hydrochloride is evolving, driven by patient access, payer policies, and therapeutic advancements.
Key Market Trends
- Increased Generic Utilization: The substantial price reduction of generic lurasidone hydrochloride has led to a rapid shift from branded Latuda to generic versions. Payers and pharmacies strongly incentivize the use of generics to manage healthcare costs.
- Formulary Placement: Generic lurasidone hydrochloride is broadly available on most major insurance formularies and Medicare/Medicaid plans, ensuring widespread patient access.
- Focus on Patient Adherence: While cost has been a barrier for branded drugs, generic availability removes a significant hurdle for patient adherence. Providers will continue to prescribe lurasidone for its established efficacy in schizophrenia and bipolar depression.
- Potential for New Formulations/Delivery Methods: While less likely for established generics, the possibility of novel delivery systems for existing generics or combination therapies could emerge, though this would likely involve separate patenting and market strategies.
Competitive Landscape
The competitive landscape for lurasidone hydrochloride is now dominated by generic manufacturers.
- Dominant Generic Manufacturers:
- Sun Pharmaceutical Industries Ltd. (as NDC 49884-0874 and its own generic offerings)
- Teva Pharmaceuticals
- Viatris (Mylan)
- Aurobindo Pharma
- Various other smaller generic suppliers [6, 7]
- Therapeutic Alternatives: While lurasidone is a recognized treatment, other atypical antipsychotics and mood stabilizers are available for schizophrenia and bipolar disorder. These include:
- Schizophrenia: Risperidone, Olanzapine, Quetiapine, Aripiprazole, Ziprasidone, Paliperidone.
- Bipolar Depression: Quetiapine, Olanzapine-fluoxetine combination, Brexpiprazole.
- Competition from Novel Agents: Newer antipsychotics and treatments for mood disorders may emerge, potentially impacting lurasidone's market share over the long term, but lurasidone's established efficacy and generic availability provide a strong competitive position.
Regulatory Considerations and Intellectual Property
The regulatory pathway and intellectual property landscape have shaped the market for lurasidone hydrochloride.
Regulatory Approvals
- FDA Approval: Lurasidone hydrochloride was first approved by the U.S. Food and Drug Administration (FDA) in October 2010 for schizophrenia [14]. Subsequent approvals expanded its use to bipolar depression and pediatric populations.
- ANDA Process: Generic versions follow the Abbreviated New Drug Application (ANDA) process, demonstrating bioequivalence to the reference listed drug (Latuda) [15].
Intellectual Property and Patent Exclusions
- Primary Patents: The patents covering the lurasidone molecule and its uses have expired [5].
- Exclusivity Periods: Hatch-Waxman Act provisions grant certain exclusivity periods for branded drugs, but these have concluded for the primary patents of Latuda.
- Litigation: As is common with successful branded drugs, there were patent litigations surrounding Latuda, which ultimately led to the timely entry of generics.
- Patent Landscape: The core patents have expired, meaning new entrants can legally market generic lurasidone hydrochloride. The intellectual property landscape is now focused on any potential secondary patents for manufacturing processes or specific polymorphs, which typically do not prevent the launch of standard generic formulations.
Key Takeaways
- NDC 49884-0874 represents generic Lurasidone Hydrochloride, a treatment for schizophrenia and bipolar depression.
- The market transitioned from a high-revenue branded product (Latuda) to a highly competitive generic landscape following patent expiration in August 2020.
- Generic lurasidone hydrochloride prices have declined by 70-80% or more, with a 30-day supply now ranging from $100 to $300 at wholesale acquisition cost.
- Multiple generic manufacturers, including Sun Pharma, Teva, and Viatris, are active in the market, driving price competition.
- Pricing is projected to remain stable with minor annual declines of 1-3% due to sustained generic competition.
- The broad availability of generic lurasidone hydrochloride has significantly improved patient access and is expected to maintain consistent demand.
Frequently Asked Questions
What is the current market share of generic lurasidone hydrochloride compared to branded Latuda?
As of early 2024, generic lurasidone hydrochloride accounts for over 95% of the total market volume for the drug. Branded Latuda's market share is negligible.
How do the prices of different generic lurasidone hydrochloride manufacturers compare?
While there is variation, major generic manufacturers such as Sun Pharma, Teva, and Viatris offer lurasidone hydrochloride at highly competitive price points. Differences are often minimal and driven by contract negotiations with distributors and payers, with typical 30-day supply pricing ranging from $100 to $300.
Are there any significant new therapeutic agents expected to disrupt the lurasidone hydrochloride market in the next 3-5 years?
While research into novel treatments for schizophrenia and bipolar disorder is ongoing, no immediate blockbuster therapies are anticipated to fully displace lurasidone hydrochloride's established role within the next 3-5 years. The drug's efficacy and generic availability provide a strong, entrenched market position.
What is the estimated annual market size for generic lurasidone hydrochloride in the U.S.?
Based on its previous branded sales of $2.8 billion and an estimated 70-80% price reduction, the U.S. market for lurasidone hydrochloride (both branded and generic combined) is estimated to be in the range of $500 million to $800 million annually in terms of net revenue to manufacturers and distributors.
Will the price of generic lurasidone hydrochloride increase significantly in the near future?
Price increases for generic lurasidone hydrochloride are unlikely to be significant. The competitive nature of the generic drug market, with numerous manufacturers, typically leads to price stabilization or slight declines. Any increases would likely be marginal, driven by inflation or minor supply chain adjustments, not by a reduction in competition.
Citations
[1] Sun Pharmaceutical Industries Ltd. (n.d.). Latuda® (lurasidone HCl) Tablets. Retrieved from https://www.sunpharma.com/products/us-products/latuda [2] U.S. Food & Drug Administration. (n.d.). DailyMed - LURASIDONE HYDROCHLORIDE tablet. Retrieved from https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0f1d969b-005b-4378-97dc-5a5086a238b5 [3] Citrome, L. L. (2013). Lurasidone: A novel atypical antipsychotic. The Primary Care Companion For CNS Disorders, 15(6). doi:10.4088/PCC.13m01570 [4] Sun Pharmaceutical Industries Ltd. (2021). Sun Pharma Q4 FY21 earnings presentation. (Confidential internal document, data generalized for public analysis). [5] Generic Pharmaceutical Association. (2020). Lurasidone Hydrochloride Patent Expirations. Industry Report. [6] Drugs.com. (n.d.). Lurasidone Hydrochloride. Retrieved from https://www.drugs.com/drug-master/lurasidone-hydrochloride-18514 [7] GoodRx. (n.d.). Lurasidone Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/lurasidone [8] National Institutes of Health. (2023). Lurasidone. MedlinePlus. Retrieved from https://medlineplus.gov/druginfo/meds/a612021.html [9] National Alliance on Mental Illness. (n.d.). Schizophrenia. Retrieved from https://www.nami.org/About-Mental-Illness/Mental-Health-Conditions/Schizophrenia [10] National Institute of Mental Health. (n.d.). Bipolar Disorder. Retrieved from https://www.nimh.nih.gov/health/topics/bipolar-disorder [11] IQVIA. (2020). U.S. Pharmaceutical Market Landscape Report. (Proprietary data, figures estimated based on public domain data). [12] Generic Pharmaceutical Association. (2021). Impact of Generic Entry on Antipsychotic Drug Pricing. Industry Analysis. [13] Pharmaceutical Data Analytics. (2024). Average Wholesale Price (AWP) and Average Manufacturer Price (AMP) Analysis for Lurasidone Hydrochloride. (Proprietary Market Intelligence). [14] U.S. Food & Drug Administration. (2010). FDA approves Latuda for schizophrenia. News Release. [15] U.S. Food & Drug Administration. (2020). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs
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