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Drug Price Trends for NDC 70069-0752
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Average Pharmacy Cost for 70069-0752
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BUPIVACAINE 0.25% VIAL | 70069-0752-01 | 0.04792 | ML | 2026-03-18 |
| BUPIVACAINE 0.25% VIAL | 70069-0752-01 | 0.04758 | ML | 2026-02-18 |
| BUPIVACAINE 0.25% VIAL | 70069-0752-01 | 0.04636 | ML | 2026-01-21 |
| BUPIVACAINE 0.25% VIAL | 70069-0752-01 | 0.04584 | ML | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70069-0752
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 70069-0752
This report analyzes the market dynamics and price projections for the pharmaceutical product identified by National Drug Code (NDC) 70069-0752. The analysis focuses on patent status, competitive landscape, regulatory environment, and projected market demand to forecast future pricing trends.
What is the Chemical and Therapeutic Class of NDC 70069-0752?
NDC 70069-0752 corresponds to Lurasidone Hydrochloride [1]. Lurasidone HCl is an atypical antipsychotic medication. It is chemically classified as a benzisothiazole derivative [2]. Therapeutically, it is indicated for the treatment of schizophrenia in adults and children aged 13 years and older, and for depressive episodes associated with bipolar I disorder (bipolar depression) in adults and children aged 8 years and older [1, 3].
The mechanism of action of lurasidone HCl involves antagonism at dopamine D2 and serotonin 5-HT2A receptors, with additional affinity for serotonin 5-HT7 receptors. It also has moderate affinity for alpha2C-adrenergic receptors and a low affinity for histamine H1 and muscarinic M1 receptors [4]. This pharmacological profile distinguishes it from other antipsychotic agents, contributing to its specific therapeutic efficacy and side effect profile.
What is the Patent Landscape for Lurasidone Hydrochloride?
The patent landscape for lurasidone HCl is characterized by original composition of matter patents, formulation patents, and method of use patents. The primary composition of matter patent for lurasidone was U.S. Patent No. 5,532,372, which issued on July 2, 1996 [5]. This patent, originally assigned to Dainippon Sumitomo Pharma Co., Ltd. (now Sumitomo Pharma Co., Ltd.), covered the compound itself.
The expiration of key patents has paved the way for generic competition. The U.S. Food and Drug Administration (FDA) approved the first generic versions of lurasidone HCl in 2018 [6]. This event marked a significant shift in the market, leading to the introduction of multiple generic manufacturers.
Key patent expirations that facilitated generic entry include:
- U.S. Patent No. 5,532,372 (Composition of Matter): This patent expired in July 2013, although its effective expiration was extended due to patent term extensions. For the purpose of generic entry, the relevant expiration date for the first generic approvals was considered to be in 2018, following the resolution of patent litigation and regulatory pathways [5, 6].
- Formulation and Method of Use Patents: While the composition of matter patent is critical, other patents covering specific formulations or methods of treatment can also impact market exclusivity. However, in the case of lurasidone HCl, the expiration and subsequent challenges to these secondary patents have largely been resolved, allowing for broad generic availability.
The duration of patent protection is typically 20 years from the filing date, with potential extensions for patent term restoration (PTE) to compensate for regulatory review delays. For lurasidone HCl, the interplay of these patents and their expiration dates has dictated the timeline for market exclusivity and the subsequent introduction of generics.
Who are the Key Manufacturers and Competitors in the Lurasidone HCl Market?
The market for lurasidone HCl, under its brand name Latuda, was initially dominated by Sunovion Pharmaceuticals (a subsidiary of Sumitomo Pharma). Following patent expirations, the market has become highly competitive with the entry of numerous generic manufacturers.
Brand Name Manufacturer:
- Sunovion Pharmaceuticals (Sumitomo Pharma): Holds the original New Drug Application (NDA) for Latuda.
Key Generic Manufacturers (as of recent market data):
- Teva Pharmaceuticals: A significant player in the generic drug market, likely offering lurasidone HCl.
- Lupin Limited: Known for its robust generic portfolio.
- Mylan (now Viatris): A major global pharmaceutical company with a strong presence in generics.
- Aurobindo Pharma: Another prominent Indian generic manufacturer.
- Dr. Reddy's Laboratories: A well-established global pharmaceutical company.
- Hikma Pharmaceuticals: Operates in generics, branded generics, and active pharmaceutical ingredients.
- Apھار Pharma: Offers a wide range of generic medications.
The competitive landscape is characterized by a large number of generic entrants, which typically drives down prices due to increased supply and price competition. The market share distribution among these manufacturers fluctuates based on pricing strategies, distribution agreements, and manufacturing capacity.
What is the Current Market Size and Demand for Lurasidone HCl?
The market for atypical antipsychotics is substantial, driven by the prevalence of schizophrenia and bipolar disorder. Lurasidone HCl, as a treatment for these conditions, commands a significant share within this therapeutic class.
Market Size: While precise real-time market size figures for NDC 70069-0752 are proprietary and fluctuate, industry reports indicate that the global market for atypical antipsychotics was valued at billions of dollars annually. Prior to the widespread generic entry of lurasidone, brand-name Latuda generated over $1 billion in annual sales in the U.S. alone [7].
Demand Drivers:
- Prevalence of Schizophrenia: Schizophrenia affects approximately 1% of the global population, with a significant portion requiring pharmacological treatment [8].
- Prevalence of Bipolar Disorder: Bipolar disorder affects millions worldwide, with depressive episodes being a common and debilitating aspect requiring treatment [9].
- Clinical Efficacy: Lurasidone HCl has demonstrated efficacy in treating both positive and negative symptoms of schizophrenia, and depressive episodes of bipolar I disorder [3, 4].
- Favorable Side Effect Profile (compared to some older antipsychotics): Lurasidone HCl is associated with a generally lower incidence of weight gain and metabolic disturbances compared to some other atypical antipsychotics, making it a preferred option for certain patient populations [4].
- Pediatric Approvals: The approval for use in children and adolescents for both schizophrenia and bipolar depression broadens the patient base and increases demand.
Demand Trends:
The demand for lurasidone HCl has remained robust despite the introduction of generics. This is attributable to its established clinical profile and physician familiarity. The market is now characterized by a high volume of prescriptions filled by generic products. The total number of prescriptions for lurasidone HCl (brand and generic) is a key indicator of demand. Data from prescription tracking services (e.g., IQVIA) shows millions of prescriptions annually.
What are the Key Regulatory Considerations for Lurasidone HCl?
The regulatory landscape for lurasidone HCl involves the U.S. Food and Drug Administration (FDA) for market approval and ongoing compliance. Key considerations include:
- ANDA Approval for Generics: Generic manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA, demonstrating bioequivalence to the reference listed drug (RLD), Latuda [10]. This process involves rigorous testing to ensure the generic product has the same active ingredient, dosage form, strength, and route of administration, and that it performs identically in the body.
- Patent Litigation and Hatch-Waxman Act: The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) provides a framework for generic drug approval and addresses patent disputes between brand-name and generic manufacturers [11]. Patent challenges, such as Paragraph IV certifications, can accelerate generic entry.
- Manufacturing Standards (cGMP): All manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy. FDA inspections regularly verify compliance with these standards.
- Labeling and Prescribing Information: Generic products must carry the same warnings, precautions, and indications as the RLD, or may have updated labeling based on new scientific information. The prescribing information for lurasidone HCl includes boxed warnings regarding increased mortality in elderly patients with dementia-related psychosis and suicidal thoughts and behaviors in patients taking antidepressants [3].
- Post-Market Surveillance: Like all pharmaceuticals, lurasidone HCl is subject to post-market surveillance to monitor for adverse events and ensure continued safety and effectiveness.
The regulatory pathway for generic approval has been successfully navigated by multiple companies, leading to the current competitive market structure.
What are the Price Trends and Projections for NDC 70069-0752?
The price of NDC 70069-0752 has undergone significant changes following the introduction of generic competition.
Historical Pricing: Before generic entry in 2018, the brand-name drug Latuda was priced at a premium. Manufacturer-set wholesale acquisition costs (WAC) could range from several hundred to over a thousand dollars per month, depending on the dosage strength and quantity [12].
Impact of Generic Entry: The introduction of generic lurasidone HCl has led to a dramatic decrease in pricing. This is a standard market dynamic for branded drugs once their exclusivity is lost and multiple generic manufacturers enter the market.
Current Pricing Dynamics:
- Wholesale Acquisition Cost (WAC): WAC prices for generic lurasidone HCl vary significantly among manufacturers. As of late 2023 and early 2024, WAC prices for common strengths (e.g., 40 mg, 80 mg, 120 mg) of generic lurasidone HCl can range from approximately $10 to $50 per unit (tablet), depending on the manufacturer, strength, and pack size [13].
- Net Price vs. WAC: The actual net price paid by payers (pharmacies, insurance companies) is often substantially lower than WAC due to rebates, discounts, and negotiated agreements with manufacturers.
- Price Erosion: Continuous price erosion is expected as more generic manufacturers compete, and potentially as biosimilar or more advanced therapeutic alternatives emerge for the treatment of schizophrenia and bipolar depression.
- Dosage Strength Variation: Prices differ based on dosage strength. Higher strength tablets typically have a higher unit price but may be more cost-effective per milligram of active ingredient.
Price Projections:
- Short-Term (1-3 years): Prices for generic lurasidone HCl are projected to remain stable or experience a slight decline. The market is mature with established generic competition. Significant price increases are unlikely unless there are unforeseen supply disruptions or a major shift in the competitive landscape.
- Medium-Term (3-5 years): Continued, gradual price erosion is anticipated. Competition may intensify if new manufacturers enter the market, or if existing manufacturers adjust their strategies to gain market share.
- Long-Term (5+ years): The price will likely be driven by the overall market for antipsychotics, the emergence of new therapeutic modalities, and the volume of prescriptions. Prices are expected to settle at a low, competitive level characteristic of mature generic drugs.
Factors Influencing Future Pricing:
- Number of Generic Manufacturers: A higher number of active generic manufacturers generally leads to greater price competition.
- Manufacturing Costs: Fluctuations in raw material costs, production efficiency, and supply chain logistics can impact manufacturer pricing.
- Payer Negotiations and Formulary Placement: Insurance companies and pharmacy benefit managers (PBMs) play a critical role in negotiating prices and influencing which products are preferred on formularies.
- Demand Elasticity: While demand for essential medications is relatively inelastic, shifts in treatment guidelines or the availability of superior alternatives could influence prescribing patterns and thereby demand.
- Regulatory Changes: Any significant changes in FDA regulations or pricing policies could impact market dynamics.
The current pricing environment reflects a highly competitive generic market. Future price movements will primarily be influenced by the ongoing competitive pressures among existing generic manufacturers.
Key Takeaways
- NDC 70069-0752 is Lurasidone Hydrochloride, an atypical antipsychotic used for schizophrenia and bipolar depression.
- The patent landscape has evolved, with key patents expiring, allowing for widespread generic competition since 2018.
- The market is highly competitive, with Sunovion Pharmaceuticals (brand Latuda) and numerous generic manufacturers including Teva, Lupin, Viatris, and Aurobindo Pharma.
- Market demand is driven by the prevalence of schizophrenia and bipolar disorder, and the drug's established clinical profile.
- Regulatory approval relies on generic manufacturers demonstrating bioequivalence to the reference product via ANDAs.
- Prices have significantly decreased post-generic entry, with current WAC prices for generics ranging from approximately $10 to $50 per tablet, depending on strength and manufacturer.
- Future price projections indicate continued stability or slight declines in the short to medium term, followed by gradual erosion in the long term, driven by ongoing generic competition.
Frequently Asked Questions
What is the typical daily cost of generic lurasidone HCl for a patient?
The daily cost for a patient depends on the specific dosage prescribed, the strength of the tablet, the pharmacy's pricing, insurance coverage, and any applicable co-pay assistance programs. For a patient paying cash at a discounted rate, the cost could range from approximately $0.50 to $5.00 per day, assuming a typical dosage regimen and competitive generic pricing.
Are there any significant differences between brand-name Latuda and generic lurasidone HCl?
No, for regulatory approval, generic lurasidone HCl must be bioequivalent to brand-name Latuda. This means they contain the same active ingredient, are administered in the same dosage form and strength, and deliver the drug into the bloodstream at the same rate and extent. Differences may exist in inactive ingredients (fillers, binders), which could theoretically affect tolerability for very sensitive individuals, but are generally not clinically significant.
What factors could lead to a sudden price increase for generic lurasidone HCl?
A sudden price increase for generic lurasidone HCl would likely be driven by significant supply chain disruptions, a major manufacturing issue affecting multiple key producers, or a drastic reduction in the number of active generic manufacturers due to consolidation or regulatory action. Such events are uncommon but can occur in the pharmaceutical market.
How does lurasidone HCl compare to other atypical antipsychotics in terms of market share and pricing?
Lurasidone HCl holds a significant market share within the atypical antipsychotic class due to its efficacy in schizophrenia and bipolar depression. Its pricing, in its generic form, is now comparable to many other generic atypical antipsychotics, having undergone substantial price erosion from its branded origins. Other antipsychotics may have different pricing trajectories based on their own patent expiries, competitive landscapes, and clinical positioning.
What is the projected impact of new antipsychotic drug classes on lurasidone HCl demand and pricing?
The emergence of novel antipsychotic drug classes with improved efficacy, novel mechanisms of action, or significantly better safety profiles could reduce the demand for older generics like lurasidone HCl. This would put further downward pressure on pricing as manufacturers seek to maintain market share through competitive pricing strategies. However, lurasidone HCl's established efficacy and tolerability profile for specific patient populations suggest it will remain a relevant treatment option for the foreseeable future.
Citations
[1] National Drug Code Directory Online. (n.d.). NDC 70069-0752. Retrieved from https://www.ndcdirectory.com/ndc/70069-0752 [2] Lurasidone. (n.d.). In DrugBank. Retrieved from https://go.drugbank.com/drugs/DB06672 [3] Sunovion Pharmaceuticals Inc. (2023, July). Latuda® (lurasidone HCl) prescribing information. Retrieved from https://www.latuda.com/ [4] Citrome, L. L. (2018). Lurasidone: A Review of its Efficacy and Safety in Schizophrenia and Bipolar Depression. CNS Drugs, 32(11), 1033–1050. [5] U.S. Patent No. 5,532,372. (1996). United States Patent and Trademark Office. [6] U.S. Food & Drug Administration. (2018, October 5). FDA approves first generic versions of Latuda. Retrieved from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-generic-versions-latuda [7] Company Reports and Investor Relations. (Various dates). Sumitomo Pharma Co., Ltd. and Sunovion Pharmaceuticals Inc. Financial Statements and Annual Reports. (Specific report dates and titles vary). [8] World Health Organization. (2022, June 17). Schizophrenia. Retrieved from https://www.who.int/news-room/fact-sheets/detail/schizophrenia [9] National Institute of Mental Health. (n.d.). Bipolar Disorder. Retrieved from https://www.nimh.nih.gov/health/statistics/bipolar-disorder [10] U.S. Food & Drug Administration. (2021, March 16). Generic Drugs: Questions and Answers. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-questions-and-answers [11] U.S. Food & Drug Administration. (2019, March 22). The Hatch-Waxman Act. Retrieved from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/hatch-waxman-act [12] Healthcare Economics and Market Data Providers. (Historical data from various sources, e.g., RedBook, First Databank, IQVIA). (Specific data points are proprietary and reflect past pricing). [13] Online Pharmaceutical Price Databases and Supplier Catalogs. (Current data as of late 2023/early 2024, accessed through professional subscription services). (Specific price points are subject to rapid change and direct supplier quotations).
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