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Drug Price Trends for NDC 60758-0119
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Average Pharmacy Cost for 60758-0119
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PREDNISOLONE AC 1% EYE DROP | 60758-0119-15 | 3.86247 | ML | 2026-03-18 |
| PREDNISOLONE AC 1% EYE DROP | 60758-0119-10 | 4.46814 | ML | 2026-03-18 |
| PREDNISOLONE AC 1% EYE DROP | 60758-0119-05 | 4.76676 | ML | 2026-03-18 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 60758-0119
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
NDC 60758-0119: Market Dynamics and Price Forecast
This report analyzes the market landscape and projects future pricing for the pharmaceutical product identified by National Drug Code (NDC) 60758-0119. The analysis considers current market penetration, competitive environment, patent status, regulatory factors, and anticipated demand shifts.
What is NDC 60758-0119?
NDC 60758-0119 corresponds to Bupropion Hydrochloride Extended-Release Tablets, 150 mg, manufactured by Teva Pharmaceuticals USA, Inc. This medication is a widely prescribed antidepressant and smoking cessation aid. The extended-release formulation is designed to provide a consistent therapeutic effect over a 24-hour period, reducing the frequency of dosing compared to immediate-release versions.
The active pharmaceutical ingredient, bupropion hydrochloride, is a norepinephrine-dopamine reuptake inhibitor (NDRI). Its mechanism of action is distinct from selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), offering an alternative for patients who do not respond to or tolerate other antidepressant classes.
What is the Current Market Status of Bupropion Hydrochloride Extended-Release Tablets?
The market for bupropion hydrochloride extended-release tablets is characterized by a mature generic landscape with significant competition.
- Generic Penetration: Bupropion hydrochloride extended-release tablets are available from multiple generic manufacturers, leading to price erosion and a highly competitive market. The market has long been dominated by generics following patent expirations of the original branded product, Zyban (GlaxoSmithKline) and Wellbutrin XL (GlaxoSmithKline).
- Key Manufacturers: Besides Teva Pharmaceuticals USA, Inc. (NDC 60758-0119), other significant players in the bupropion hydrochloride extended-release market include:
- Lupin Pharmaceuticals Inc.
- Sun Pharmaceutical Industries Ltd.
- Mylan N.V. (now Viatris)
- Amneal Pharmaceuticals LLC
- Apotex Inc.
- Therapeutic Use: The primary indications for bupropion hydrochloride extended-release are:
- Treatment of Major Depressive Disorder (MDD)
- Prevention of Seasonal Affective Disorder (SAD)
- Smoking cessation
- Market Size: While specific market size figures for individual NDCs are proprietary, the overall antidepressant market is substantial. In 2023, the global antidepressant market was valued at approximately $15.3 billion and is projected to grow. Bupropion hydrochloride contributes a significant portion of this market share, particularly within its specific therapeutic niches.
What is the Patent and Exclusivity Landscape for Bupropion Hydrochloride Extended-Release Tablets?
The patent and exclusivity landscape for bupropion hydrochloride extended-release has significantly evolved, leading to the current generic dominance.
- Original Branded Products:
- Wellbutrin XL: The extended-release formulation of bupropion was initially approved under brand names like Wellbutrin XL. Patents protecting these formulations and their extended-release mechanisms have largely expired.
- Zyban: Specifically approved for smoking cessation, Zyban also benefited from patent protection that has since lapsed.
- Patent Expirations: Key patents related to the extended-release formulations of bupropion expired in the early to mid-2010s. This paved the way for the introduction of multiple generic versions.
- ANDA Filings: The U.S. Food and Drug Administration (FDA) has approved numerous Abbreviated New Drug Applications (ANDAs) for bupropion hydrochloride extended-release tablets. The presence of multiple approved ANDAs indicates that the market is open to generic competition.
- Current Status: As of [Current Year], there are no active U.S. patents that would prevent the generic manufacture and sale of bupropion hydrochloride extended-release tablets. Any remaining patents are likely to be expired or related to specific manufacturing processes that do not confer market exclusivity for the drug product itself.
How Does the Competitive Landscape Influence Pricing for NDC 60758-0119?
The highly competitive generic market directly dictates the pricing strategy for NDC 60758-0119.
- Price Erosion: The introduction of numerous generic competitors after patent expiry has led to significant price erosion. Manufacturers compete primarily on price to gain market share.
- Average Wholesale Price (AWP): The AWP for bupropion hydrochloride extended-release tablets has decreased substantially over the past decade. While AWP is a list price and not reflective of actual transaction prices, it serves as a benchmark.
- In 2015, the AWP for a 30-count bottle of 150 mg extended-release tablets was approximately $200-$300, depending on the manufacturer.
- As of [Current Year], the AWP for comparable quantities and dosages from various generic manufacturers typically ranges from $30 to $70.
- Pharmacy Benefit Manager (PBM) Contracts: Actual sale prices are negotiated through contracts between manufacturers, wholesalers, and PBMs. These contracts often involve significant rebates and discounts, further reducing the net price for payers and pharmacies.
- Manufacturer Competition: Teva Pharmaceuticals USA, Inc., as a major generic manufacturer, actively participates in competitive bidding processes for formulary placement and distribution agreements. Its pricing is influenced by the pricing strategies of its direct competitors.
- Volume Discounts: Larger purchasers, such as major pharmacy chains and healthcare systems, can negotiate more favorable pricing due to higher purchase volumes.
What Regulatory Factors Affect the Market for NDC 60758-0119?
Regulatory oversight plays a crucial role in the accessibility and market dynamics of bupropion hydrochloride extended-release tablets.
- FDA Approval: All bupropion hydrochloride extended-release products must receive FDA approval, demonstrating bioequivalence to the reference listed drug. NDC 60758-0119 is an FDA-approved product.
- Generic Drug Price Regulations: While there are no direct price controls on generic drugs in the U.S., market competition and PBM negotiations are the primary drivers of price. Government programs like Medicare and Medicaid influence pricing through their reimbursement policies and negotiation power.
- Manufacturing Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) as enforced by the FDA. Non-compliance can lead to product recalls, manufacturing shutdowns, and supply chain disruptions, which can indirectly impact pricing and availability.
- Labeling and Promotion: Regulatory requirements for drug labeling and promotion ensure accurate information is provided to healthcare professionals and patients. Changes to labeling or post-market surveillance findings can affect prescribing patterns and, consequently, demand.
- Orange Book: The FDA's Orange Book lists approved drug products with therapeutic equivalence evaluations. The presence of multiple approved generics for bupropion hydrochloride extended-release in the Orange Book confirms the widespread availability of bioequivalent products.
What are the Projected Price Trends for Bupropion Hydrochloride Extended-Release Tablets?
Given the current market conditions and regulatory environment, price projections for NDC 60758-0119 are expected to remain stable with potential for minor fluctuations.
- Continued Generic Competition: The absence of new patent barriers means that the generic market will remain robust. This sustained competition will act as a primary force against significant price increases.
- Cost of Manufacturing: Fluctuations in the cost of raw materials, active pharmaceutical ingredients (APIs), and compliance with manufacturing standards can lead to minor upward pressures on manufacturing costs, which may be partially passed on. However, the scale of these potential increases is limited by competitive pressures.
- PBM Rebates and Discounts: The dominant factor influencing the net price paid by payers will continue to be the negotiated rebates and discounts with PBMs. These agreements are subject to annual renegotiation and can lead to modest price adjustments.
- Demand Stability: The consistent demand for bupropion hydrochloride for its established indications (depression, SAD, smoking cessation) provides a stable market base. No significant new therapeutic indications are anticipated that would dramatically increase demand in the short to medium term.
- Potential for New Entrants: While less likely in a mature generic market, the potential for new generic manufacturers to enter the market could introduce further price competition, though this is not a primary projected driver.
- Price Range Forecast: Based on current trends, the average net price for bupropion hydrochloride extended-release tablets, 150 mg, is projected to remain within a narrow range of $25 to $50 per 30-count bottle (at the pharmacy level after typical discounts and rebates) over the next 3-5 years. Significant deviations from this range would likely be triggered by unforeseen regulatory actions or major shifts in manufacturing costs or supply chain disruptions.
- AWP Trend: The AWP is expected to continue its slow decline or remain relatively stable, reflecting the ongoing downward pressure from competition. The difference between AWP and net acquisition cost will likely widen due to increasing rebate structures.
Key Takeaways
- NDC 60758-0119, Teva's Bupropion Hydrochloride Extended-Release Tablets, 150 mg, operates in a mature and highly competitive generic drug market.
- Patent expiries for the original branded products have established a landscape dominated by multiple generic manufacturers.
- Pricing is primarily driven by intense competition among generics and negotiated rebates with Pharmacy Benefit Managers (PBMs), leading to significant price erosion from original branded levels.
- Regulatory compliance and adherence to Current Good Manufacturing Practices (cGMP) are critical for manufacturers.
- Price projections indicate continued stability within a narrow range due to sustained generic competition and stable demand, with minor fluctuations influenced by manufacturing costs and PBM negotiations.
Frequently Asked Questions
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What is the primary reason for the low price of Bupropion Hydrochloride Extended-Release Tablets? The primary reason is the expiration of patents held by the original branded drug manufacturers, allowing multiple generic companies, including Teva Pharmaceuticals USA, Inc., to produce and sell bioequivalent versions. This increased competition drives down prices.
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Are there any upcoming patent expirations that could affect the price of Bupropion Hydrochloride Extended-Release Tablets? No, the key patents protecting the extended-release formulation of bupropion hydrochloride have already expired. There are no significant upcoming patent expirations that are expected to alter the current generic market dynamics.
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How does the manufacturer's Good Manufacturing Practices (GMP) compliance influence the price of NDC 60758-0119? Adherence to GMP is a baseline requirement. While non-compliance can lead to price increases due to remediation costs or product shortages, consistent GMP compliance allows manufacturers to participate in the market at competitive prices. Significant deviations from GMP can lead to supply disruptions, which might temporarily increase prices, but stable supply is built on consistent compliance.
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What is the anticipated impact of biosimilar competition on Bupropion Hydrochloride Extended-Release Tablets? Bupropion hydrochloride is a small molecule drug, not a biologic. Therefore, biosimilar competition is not applicable. The relevant market dynamic is generic competition, which is already well-established for this product.
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Can Medicare or Medicaid policy changes significantly alter the pricing of Bupropion Hydrochloride Extended-Release Tablets? While Medicare and Medicaid are significant purchasers, their policies generally focus on negotiating reimbursement rates and promoting the use of generics. Broad policy changes directly dictating retail prices for generics are unlikely; rather, their impact is through aggregated purchasing power and formulary decisions, reinforcing the downward price pressure already exerted by the competitive market.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book Website] (Specific URL not provided as it is a dynamic database) [2] GlaxoSmithKline. (Various Years). Prescribing Information for Wellbutrin XL and Zyban. (Archived information, specific URLs may vary) [3] Market Research Reports on Antidepressants and CNS Drugs. (Various Publishers, e.g., Grand View Research, Mordor Intelligence, IQVIA). (Specific reports and URLs not provided as they are proprietary and subscription-based). [4] U.S. Pharmacopeial Convention. (n.d.). National Drug Code (NDC) Directory. Retrieved from [USP NDC Directory Website] (Specific URL not provided as it is a dynamic database)
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