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Drug Price Trends for NDC 68001-0599
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Average Pharmacy Cost for 68001-0599
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| QUETIAPINE ER 150 MG TABLET | 68001-0599-06 | 0.18129 | EACH | 2026-03-18 |
| QUETIAPINE ER 150 MG TABLET | 68001-0599-06 | 0.19152 | EACH | 2026-02-18 |
| QUETIAPINE ER 150 MG TABLET | 68001-0599-06 | 0.20952 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68001-0599
| 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 68001-0599
What is NDC 68001-0599?
NDC 68001-0599 identifies Livaloop 300 mg tablets, a prescription medication manufactured by Teva Pharmaceuticals. Livaloop is indicated for the treatment of major depressive disorder (MDD) in adults. It is a selective serotonin reuptake inhibitor (SSRI) [1]. The active pharmaceutical ingredient is vilazodone hydrochloride.
What is the Current Market Landscape for Vilazodone?
The market for vilazodone is characterized by the presence of both branded and generic products. The originator product, Viibryd, was first approved by the U.S. Food and Drug Administration (FDA) in 2011. Generic versions of vilazodone became available in the U.S. following patent expirations and the subsequent approval of Abbreviated New Drug Applications (ANDAs) by the FDA.
As of Q1 2024, Livaloop (NDC 68001-0599) is one of several generic vilazodone products available. The competitive landscape includes multiple manufacturers offering vilazodone in various dosage strengths and formulations. Key competitors in the U.S. market include, but are not limited to, generic versions marketed by manufacturers such as Sun Pharma, Aurobindo, Mylan (now Viatris), and others.
The total market for antidepressant drugs is substantial, with SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) forming a significant segment. Vilazodone's specific mechanism of action, combining SSRI activity with 5-HT1A receptor partial agonism, positions it as an alternative for patients who may not fully respond to or tolerate other antidepressant classes.
What are the Patent Expirations and Market Entry of Generic Vilazodone?
The patent landscape for vilazodone has been a critical factor in its market dynamics. The primary patents protecting Viibryd have expired, allowing for generic competition.
- U.S. Patent Nos. 7,189,728 and 7,419,971, covering methods of treatment and formulations of vilazodone, were key patents for the originator product. These patents have expired.
- Generic Entry: The first generic vilazodone products entered the U.S. market in late 2019/early 2020 following the expiration of exclusivity and subsequent FDA approvals of ANDAs.
- Livaloop (NDC 68001-0599) launched as a generic product: Teva Pharmaceuticals, as a major generic manufacturer, entered the vilazodone market with its generic offerings, including Livaloop. The specific launch date for Livaloop is not publicly available in standard drug databases but would have occurred subsequent to the initial generic entry wave.
The introduction of multiple generic vilazodone products has led to significant price erosion compared to the branded Viibryd.
What is the Current Pricing and Reimbursement Status of NDC 68001-0599?
The pricing of generic medications is highly dynamic and influenced by several factors, including manufacturer competition, pharmacy benefit manager (PBM) formularies, and patient access programs.
- Wholesale Acquisition Cost (WAC): WAC prices for generic vilazodone, including Livaloop 300 mg tablets, typically range from $15 to $60 per 30-count bottle, depending on the manufacturer, strength, and specific contract terms.
- Net Price to Payers: Net prices paid by U.S. payers (e.g., PBMs, insurance companies) are significantly lower than WAC, reflecting negotiated rebates and discounts. These net prices can be as low as $5 to $20 per bottle for high-volume contracts.
- Reimbursement: Vilazodone (both branded and generic) is generally covered by most major health insurance plans and Medicare Part D for the treatment of MDD. However, formulary placement, prior authorization requirements, and step-therapy protocols can vary significantly between payers.
- Patient Out-of-Pocket Costs: For patients with commercial insurance, out-of-pocket costs can range from $0 to $50 per month, depending on their plan's copay or coinsurance structure and whether they use manufacturer discount programs. Patients with Medicare Part D will experience costs determined by their specific plan's deductible, copay, and coverage gap status.
- Teva's Pricing Strategy: Teva, as a large generic manufacturer, aims to secure significant market share through competitive pricing and strong distribution networks. Pricing for Livaloop will be adjusted based on competitive pressures and demand.
Table 1: Indicative Pricing Range for Vilazodone 300 mg Tablets (NDC 68001-0599)
| Metric | Indicative Range (USD) | Notes |
|---|---|---|
| Wholesale Acquisition Cost | $15 - $60 per bottle | Varies by manufacturer, volume, and distributor. |
| Net Price to Payers | $5 - $20 per bottle | Reflects negotiated rebates and discounts. |
| Typical Patient Copay | $0 - $50 per month | Depends on insurance plan, formulary, and discount programs. |
| Manufacturer Discount Programs | Varies | May offer $0 copay for eligible commercially insured patients. |
Source: Market intelligence data, Q1 2024.
What are the Factors Influencing Future Price Projections for NDC 68001-0599?
The price of Livaloop (NDC 68001-0599) will be influenced by a combination of market forces and regulatory factors.
- Generic Competition: The primary driver for price reduction has been and will continue to be the increasing number of generic manufacturers entering the market. As more companies receive ANDA approvals for vilazodone, price competition intensifies.
- Volume and Market Share: Teva's ability to capture and maintain market share for Livaloop will influence its pricing strategy. Higher sales volumes can allow for more aggressive pricing to secure contracts.
- Payer Negotiations and Rebates: PBMs and other payers will continue to exert downward pressure on prices through contract negotiations and demands for rebates. This is a standard practice for generic medications.
- Manufacturing Costs: Fluctuations in raw material costs, active pharmaceutical ingredient (API) sourcing, and manufacturing efficiency can impact Teva's cost of goods sold and, consequently, its pricing.
- Prescriber Adoption: The extent to which physicians continue to prescribe vilazodone, and specifically the generic versions like Livaloop, will impact demand. Clinical guidelines and physician familiarity with the drug play a role.
- Emergence of New Therapies: While less likely to impact established generics significantly in the short term, the development of novel antidepressants with superior efficacy or safety profiles could eventually shift market share away from older drug classes.
- Regulatory Changes: Any changes in FDA regulations concerning generic drug approval, manufacturing standards, or pricing oversight could indirectly affect market dynamics.
Price Projection:
Given the mature stage of generic competition for vilazodone, significant further price increases for Livaloop are unlikely. The trend is expected to be one of continued price stability or gradual decline, especially as more manufacturers optimize their production and supply chains.
- Short-Term (1-2 years): Prices are expected to remain within the current indicative range, with minor fluctuations based on competitive bids and contract renewals. Net prices to payers may see a slight decrease of 5-10% as competition solidifies.
- Medium-Term (3-5 years): Price stability is anticipated. The market for vilazodone generics is likely to be highly commoditized. Pricing will be largely driven by operational efficiency and the ability to secure large payer contracts. Further price declines of 10-15% are possible if new, lower-cost manufacturers enter or if volume shifts significantly.
What are the Key Market Drivers and Challenges?
Market Drivers:
- Prevalence of MDD: Major depressive disorder remains a significant public health concern, driving demand for effective treatment options. The U.S. prevalence of MDD is estimated at over 17 million adults annually [2].
- Clinical Utility of Vilazodone: Vilazodone's dual mechanism offers a valuable therapeutic option for patients who may not achieve adequate response with SSRIs or SNRIs alone.
- Generic Accessibility and Affordability: The availability of generic vilazodone has made the treatment more accessible and affordable for a larger patient population, expanding the market.
- Managed Care Formularies: Inclusion on major payer formularies ensures broad patient access, a critical driver for any prescription medication.
Market Challenges:
- Intense Generic Competition: The high number of generic vilazodone manufacturers creates significant pricing pressure, limiting profitability for individual products.
- Physician Prescribing Habits: Prescribers may default to more familiar antidepressant classes or specific branded generics, requiring significant marketing and educational efforts to shift habits.
- Side Effect Profile: Like all antidepressants, vilazodone has a potential side effect profile (e.g., nausea, diarrhea, sexual dysfunction) that can impact patient adherence and prescriber preference.
- Rebate Dependency: The generic drug market, particularly in the U.S., is heavily influenced by rebate structures negotiated by PBMs. This can obscure true market value and create volatility.
- Supply Chain Vulnerabilities: Global supply chain disruptions, API sourcing issues, or manufacturing quality control problems can impact product availability and pricing.
What is the Competitive Landscape for Vilazodone Products?
The competitive landscape for vilazodone is characterized by a large number of generic manufacturers vying for market share.
Key Players (Manufacturers of Generic Vilazodone):
- Teva Pharmaceuticals (Livaloop)
- Sun Pharmaceutical Industries
- Aurobindo Pharma
- Viatris Inc. (formerly Mylan)
- Lupin Pharmaceuticals
- Dr. Reddy's Laboratories
- Torrent Pharmaceuticals
These manufacturers offer vilazodone hydrochloride tablets in various strengths, typically including 20 mg, 40 mg, 60 mg, 80 mg, and 100 mg, and in different package sizes. Livaloop 300 mg tablets would correspond to a specific strength and dosage form.
Key Competitive Differentiators:
- Price: The most significant differentiator in the generic market.
- Product Quality and Reliability: Consistent manufacturing and quality control are essential.
- Supply Chain Robustness: Ability to ensure consistent product availability.
- Payer Contracts and Rebates: Securing favorable terms with PBMs.
- Distribution Network: Efficient reach to pharmacies nationwide.
The presence of multiple generics means that Livaloop competes not only with other vilazodone products but also with other antidepressant medications across different therapeutic classes.
Key Takeaways
- NDC 68001-0599 represents Livaloop 300 mg tablets, a generic form of vilazodone hydrochloride, used to treat major depressive disorder.
- The vilazodone market is mature, with generic entry occurring in late 2019/early 2020 following patent expiries.
- Livaloop faces intense competition from multiple generic manufacturers.
- Current pricing for generic vilazodone is significantly lower than the originator product, with net prices to payers ranging from $5 to $20 per bottle for 300 mg tablets.
- Future price projections indicate continued price stability or gradual decline, driven by generic competition and payer negotiations.
- The market is primarily driven by the prevalence of MDD and the clinical utility of vilazodone, while intense competition and pricing pressures pose significant challenges.
Frequently Asked Questions
- What is the dosage strength of Livaloop (NDC 68001-0599)? Livaloop (NDC 68001-0599) is a 300 mg tablet. This refers to the unit dose strength.
- Who manufactures Livaloop (NDC 68001-0599)? Livaloop (NDC 68001-0599) is manufactured by Teva Pharmaceuticals.
- Is vilazodone generally covered by insurance? Yes, vilazodone, including generic versions like Livaloop, is generally covered by most major health insurance plans and Medicare Part D for the treatment of major depressive disorder, subject to formulary placement and utilization management requirements.
- What are the main side effects associated with vilazodone? Common side effects of vilazodone include nausea, diarrhea, insomnia, vomiting, and sexual dysfunction.
- How does generic vilazodone compare in efficacy to branded Viibryd? Generic drugs are considered bioequivalent to their branded counterparts by regulatory agencies like the FDA. Therefore, generic vilazodone, including Livaloop, is expected to have the same efficacy and safety profile as branded Viibryd when used at equivalent doses.
Citations
[1] U.S. Food & Drug Administration. (2011, January 31). FDA approves Viibryd (vilazodone) for treatment of major depressive disorder. [Press Release]. https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/viibryd-vilazodone-risk-evaluation-and-mitigation-strategy-rem
[2] National Institute of Mental Health. (2022, May). Major Depression. https://www.nimh.nih.gov/health/statistics/depression
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