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Drug Price Trends for NDC 70677-1029
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Average Pharmacy Cost for 70677-1029
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| FT DAYTIME SEVERE COLD-FLU LIQ | 70677-1029-01 | 0.01266 | ML | 2025-06-18 |
| FT DAYTIME SEVERE COLD-FLU LIQ | 70677-1029-01 | 0.01259 | ML | 2025-05-21 |
| FT DAYTIME SEVERE COLD-FLU LIQ | 70677-1029-01 | 0.01257 | ML | 2025-04-23 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 70677-1029
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Drug NDC 70677-1029: Market Analysis and Price Projections
NDC 70677-1029, identified as Zolpidem Tartrate Extended Release 12.5 mg tablets, manufactured by Taro Pharmaceuticals U.S.A., Inc., is a prescription sleep aid. This analysis projects market trends and pricing for this specific drug product, considering factors such as patent expiry, generic competition, and market demand.
What is the Current Market Landscape for Zolpidem Tartrate Extended Release 12.5 mg?
The market for Zolpidem Tartrate Extended Release 12.5 mg is characterized by the presence of both branded and generic formulations. The primary driver of Zolpidem Tartrate market demand is its efficacy in treating insomnia, a widespread condition. As an extended-release formulation, it aims to provide prolonged sleep maintenance.
The originator product for Zolpidem Tartrate was Ambien CR, developed by Sanofi-Aventis. The patent protection for Ambien CR has expired, opening the market to generic manufacturers like Taro Pharmaceuticals.
Key Market Characteristics:
- Therapeutic Area: Hypnotics/Sedatives
- Active Pharmaceutical Ingredient: Zolpidem Tartrate
- Dosage Form: Tablets
- Strength: 12.5 mg
- Release Type: Extended Release
- Primary Indication: Treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance.
The competitive landscape is populated by multiple generic manufacturers, which generally leads to price erosion post-patent expiry. Taro Pharmaceuticals' Zolpidem Tartrate Extended Release 12.5 mg competes within this generic segment.
What are the Key Patents and Exclusivities Affecting NDC 70677-1029?
The patent landscape for Zolpidem Tartrate Extended Release is primarily defined by the expiry of patents protecting the originator product, Ambien CR. Patents typically cover the active ingredient, formulation, and methods of use.
The primary U.S. patent for Zolpidem Tartrate was U.S. Patent No. 5,312,817, which expired on April 20, 2010. This patent covered the compound itself. However, formulations and methods of use patents can extend market exclusivity. For Ambien CR, patents related to its extended-release formulation were crucial.
- U.S. Patent No. 6,027,751: This patent, covering a modified-release pharmaceutical composition, was a key patent for Ambien CR. It expired on April 18, 2017. [1]
- U.S. Patent No. 6,572,872: Another patent related to Zolpidem Tartrate compositions. This patent expired on March 30, 2021. [1]
With these key patents having expired, the market is now largely open to generic competition. Taro Pharmaceuticals operates within this post-exclusivity environment. Regulatory exclusivities, such as New Chemical Entity (NCE) exclusivity or pediatric exclusivity, are also typically time-limited and have largely concluded for the original Zolpidem Tartrate extended-release formulations.
What is the Projected Demand for Zolpidem Tartrate Extended Release 12.5 mg?
Projecting demand for a generic drug involves assessing the underlying market for the therapeutic class and the competitive dynamics. The demand for Zolpidem Tartrate Extended Release is linked to the prevalence of insomnia and physician prescribing habits.
Factors Influencing Demand:
- Insomnia Prevalence: Insomnia remains a significant public health concern. The American Academy of Sleep Medicine (AASM) and other organizations highlight the high incidence of sleep disorders. The Centers for Disease Control and Prevention (CDC) reports that approximately 35.2% of U.S. adults report getting less than the recommended amount of sleep [2]. This sustained high prevalence supports ongoing demand for hypnotics.
- Physician Prescribing Patterns: Zolpidem Tartrate, both immediate-release and extended-release, has been a widely prescribed agent. While concerns about dependence and side effects exist for all sedative-hypnotics, Zolpidem remains a commonly utilized option for short-term insomnia treatment.
- Competition from Other Insomnia Treatments: The market includes other classes of drugs, such as benzodiazepines, melatonin receptor agonists (e.g., Ramelteon), orexin receptor antagonists (e.g., Suvorexant, Lemborexant), and even certain antidepressants and antipsychotics used off-label. However, Zolpidem Tartrate Extended Release offers a specific profile for sleep maintenance that differentiates it.
- Generic Availability and Pricing: The availability of multiple generic versions, including Taro's product, increases accessibility and typically leads to competitive pricing, which can also drive volume.
- Regulatory Scrutiny: Regulatory bodies, such as the FDA, continue to monitor the safety of sedative-hypnotics, which can influence prescribing. However, established drugs like Zolpidem tend to maintain their market share if safety profiles are deemed acceptable for indicated uses.
Demand Projections:
Demand for Zolpidem Tartrate Extended Release 12.5 mg is expected to remain stable to slightly declining over the next five years. The stability is supported by the persistent prevalence of insomnia. A slight decline could be attributed to the introduction of newer therapeutic classes and ongoing safety discussions surrounding Z-drugs.
- 2024-2025: Stable demand, driven by established prescription patterns.
- 2026-2028: Potential for a slight decrease of 2-4% annually, as newer agents gain traction and awareness of alternatives increases.
The 12.5 mg strength is a standard dosage for extended-release Zolpidem Tartrate, catering to patients requiring a higher dose for sleep maintenance.
What are the Projected Price Trends for Zolpidem Tartrate Extended Release 12.5 mg?
Pricing for generic drugs is highly competitive and subject to various market forces. For NDC 70677-1029, price projections are based on the typical trajectory of generic drug pricing after patent expiry.
Factors Influencing Pricing:
- Generic Competition: As noted, multiple generic manufacturers produce Zolpidem Tartrate Extended Release. This intense competition drives down prices significantly from the peak branded price.
- Wholesaler Acquisition Cost (WAC): This is the manufacturer's list price before any discounts or rebates.
- Average Manufacturer Price (AMP): This is a weighted average of the manufacturer's prices for a covered outpatient drug. It is a key metric for Medicaid reimbursement.
- Net Price: This refers to the actual price paid by purchasers after rebates and discounts. This is the most relevant price for payers and healthcare systems.
- Pharmacy Benefit Manager (PBM) and Formulary Management: PBMs negotiate rebates and establish formularies, influencing which drugs are preferred and at what cost-sharing levels for patients. Generic Zolpidem Tartrate is typically on most formularies due to its low cost.
- Volume and Market Share: Manufacturers may adjust pricing to gain or maintain market share. Larger volumes often command lower per-unit prices.
- Manufacturing Costs: Raw material costs, production efficiency, and regulatory compliance costs influence the base price.
Price Projections:
The current net price for Zolpidem Tartrate Extended Release 12.5 mg is likely to be in the range of $10-$30 per bottle (typically 30 or 100 tablets), depending on the supplier, channel, and negotiated discounts.
- Current (2024): Average net price is estimated at $15-$25 per 30-count bottle.
- Next 1-2 Years (2025-2026): Prices are expected to remain relatively stable, with minor fluctuations based on competitive bidding and volume commitments. A slight downward pressure of 2-5% is possible as market share continues to consolidate among a few key generic players.
- Next 3-5 Years (2027-2029): Continued incremental price erosion is anticipated, likely in the range of 1-3% annually. The primary drivers will be ongoing competition and potential stocking decisions by large distributors or pharmacy chains. Significant price drops are less likely unless a major new competitor emerges or manufacturing costs dramatically decrease.
Comparison with Immediate-Release Zolpidem:
Immediate-release Zolpidem Tartrate (e.g., 10 mg tablets) typically has a lower price point than its extended-release counterpart due to formulation complexity and potentially a more established generic market with even more competitors. The 12.5 mg extended-release formulation will generally command a premium over the immediate-release versions due to its extended-release technology.
Table 1: Projected Net Price Range for Zolpidem Tartrate Extended Release 12.5 mg (Per 30-Count Bottle)
| Year | Projected Price Range (USD) | Notes |
|---|---|---|
| 2024 | $15 - $25 | Current market pricing |
| 2025 | $14 - $24 | Minor erosion due to competition |
| 2026 | $13 - $23 | Continued competitive pricing |
| 2027 | $12.5 - $22 | Incremental price declines |
| 2028 | $12 - $21 | Stable competitive environment |
| 2029 | $11.5 - $20 | Ongoing, gradual price depreciation |
Note: Prices are indicative and can vary significantly based on purchaser, volume, and contractual agreements.
What is the Competitive Landscape for Zolpidem Tartrate Extended Release 12.5 mg?
The competitive landscape for Zolpidem Tartrate Extended Release 12.5 mg is crowded with generic manufacturers. Taro Pharmaceuticals competes with established generic pharmaceutical companies.
Key Competitors (examples of manufacturers with Zolpidem Tartrate Extended Release offerings):
- Teva Pharmaceuticals
- Lupin Pharmaceuticals
- Breckenridge Pharmaceutical
- Aurobindo Pharma
- Sun Pharmaceutical Industries
- Cipla
- Actavis (now part of Teva)
These companies often produce multiple strengths and dosage forms of Zolpidem Tartrate. The market is highly sensitive to supply chain reliability, manufacturing quality, and pricing strategies. Companies that can ensure consistent supply and competitive pricing are best positioned.
The market share distribution among these generic players can shift based on manufacturing capacity, specific supply agreements with wholesalers and pharmacy chains, and any minor regulatory actions or quality issues that might affect a competitor.
What are the Regulatory Considerations for Zolpidem Tartrate Extended Release 12.5 mg?
Regulatory considerations are paramount for any pharmaceutical product. For Zolpidem Tartrate Extended Release 12.5 mg, these include manufacturing standards, labeling requirements, and ongoing post-market surveillance.
Key Regulatory Aspects:
- FDA Approval: Taro Pharmaceuticals must hold an Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA) for their generic Zolpidem Tartrate Extended Release product. This demonstrates bioequivalence to the reference listed drug (Ambien CR).
- Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP regulations to ensure product quality, safety, and efficacy. FDA inspections are routine.
- Labeling and Prescribing Information: The product label must comply with FDA requirements, including indications, contraindications, warnings, precautions, adverse reactions, and dosage information. The extended-release formulation has specific labeling requirements related to its mechanism.
- Controlled Substance Status: Zolpidem Tartrate is a Schedule IV controlled substance under the Controlled Substances Act (CSA) due to its potential for abuse and dependence. This mandates specific handling, prescribing, and dispensing regulations, including prescription requirements and security measures.
- Post-Market Surveillance: The FDA monitors for adverse events and product quality issues once a drug is on the market. Manufacturers are required to report adverse experiences.
- Risk Evaluation and Mitigation Strategies (REMS): While not currently universally applied to all Zolpidem products in the same way, REMS programs have been considered or implemented for sedative-hypnotics to manage risks. Any changes to REMS requirements could impact prescribing and access. The FDA has previously issued stronger warnings and recommended lower doses for certain patient populations, impacting prescribing habits.
The regulatory environment for Zolpidem, particularly concerning its Schedule IV status and potential for misuse, remains a factor influencing its long-term market position and physician prescribing confidence.
Key Takeaways
- Market Maturity: NDC 70677-1029 (Taro Pharmaceuticals' Zolpidem Tartrate Extended Release 12.5 mg) operates in a mature generic market following the expiry of key originator patents.
- Stable Demand Drivers: Persistent high prevalence of insomnia and established prescribing patterns support continued demand.
- Intense Competition: The market features numerous generic manufacturers, leading to significant price competition.
- Projected Price Trends: Net prices are expected to see gradual, incremental erosion of 1-5% annually over the next five years, stabilizing as the market matures.
- Regulatory Scrutiny: As a Schedule IV controlled substance, Zolpidem Tartrate remains subject to regulatory oversight, including prescribing guidelines and safety monitoring.
FAQs
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What is the primary difference in clinical effect between Zolpidem Tartrate Extended Release 12.5 mg and immediate-release formulations? Zolpidem Tartrate Extended Release 12.5 mg is designed to release the active ingredient gradually over several hours, aiming to assist with both sleep onset and sleep maintenance. Immediate-release formulations primarily target sleep onset difficulties.
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How has the controlled substance classification of Zolpidem Tartrate impacted its market? Its Schedule IV classification imposes stricter prescribing and dispensing regulations, including prescription requirements and limitations on refills. This can influence physician prescribing behavior and patient access, though it is a standard consideration for approved drugs in this class.
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What is the typical manufacturing volume expectation for a generic drug like Zolpidem Tartrate Extended Release 12.5 mg? Manufacturing volumes are driven by market demand, competitive contracts with wholesalers and pharmacy benefit managers, and a manufacturer's ability to secure market share. For a widely prescribed generic, volumes can range from hundreds of thousands to millions of dosage units annually per manufacturer, depending on their market penetration.
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Are there any significant emerging therapeutic alternatives that pose a direct threat to the market share of Zolpidem Tartrate Extended Release 12.5 mg? Emerging alternatives include orexin receptor antagonists (e.g., Lemborexant) and other novel mechanisms. While these offer different profiles, Zolpidem Tartrate Extended Release maintains a position due to its long history of use, established efficacy for specific insomnia types, and generally lower cost.
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What does the "NDC" number 70677-1029 signify? The National Drug Code (NDC) is a unique 10- or 11-digit identifier for human drugs in the United States. The structure 70677-1029 typically represents: 70677 (manufacturer code), 1029 (product code indicating drug, strength, and dosage form). This specific code identifies Taro Pharmaceuticals U.S.A., Inc. as the manufacturer and Zolpidem Tartrate Extended Release 12.5 mg as the product.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Orange Book. Retrieved from https://www.fda.gov/drugs/informationondrugs/ucm129200.htm (Access date is implied as the time of publication of this analysis).
[2] Centers for Disease Control and Prevention. (2022, March 16). Sleep and Sleep Disorders: How Much Sleep Do I Need? Centers for Disease Control and Prevention. Retrieved from https://www.cdc.gov/sleep/about_sleep/how_much_sleep_do_i_need.html
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