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Drug Price Trends for NDC 58151-0155
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Average Pharmacy Cost for 58151-0155
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| LIPITOR 10 MG TABLET | 58151-0155-77 | 13.40569 | EACH | 2026-01-01 |
| LIPITOR 10 MG TABLET | 58151-0155-77 | 12.76732 | EACH | 2025-12-17 |
| LIPITOR 10 MG TABLET | 58151-0155-77 | 12.74709 | EACH | 2025-11-19 |
| LIPITOR 10 MG TABLET | 58151-0155-77 | 12.76311 | EACH | 2025-10-22 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 58151-0155
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Analysis of NDC 58151-0155: Market Dynamics and Price Projections
This analysis details the current market position and projected price trajectory for the drug identified by National Drug Code (NDC) 58151-0155. The assessment incorporates an evaluation of its therapeutic class, competitive landscape, patent status, and recent market performance to forecast future pricing and market access.
What is NDC 58151-0155?
NDC 58151-0155 is the unique identifier for a pharmaceutical product. The specific drug associated with this NDC is Duloxetine Hydrochloride Delayed-Release Capsules, 30 mg. This medication is an antidepressant belonging to the serotonin-norepinephrine reuptake inhibitor (SNRI) class. It is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), fibromyalgia, and neuropathic pain associated with diabetic peripheral neuropathy.
What is the Therapeutic Class and Mechanism of Action?
Duloxetine hydrochloride is an SNRI. It works by increasing the levels of serotonin and norepinephrine in the brain, neurotransmitters that play a role in mood regulation and pain perception. By inhibiting the reuptake of these neurotransmitters, duloxetine enhances their availability in the synaptic cleft, thereby alleviating symptoms of depression, anxiety, and pain.
Who are the Key Manufacturers and Marketers?
The primary manufacturer and marketer of the branded version of duloxetine hydrochloride is Eli Lilly and Company, marketed under the brand name Cymbalta.
Following patent expirations, numerous generic manufacturers have entered the market. Key generic players include:
- Teva Pharmaceuticals
- Mylan (now Viatris)
- Lupin Pharmaceuticals
- Sun Pharmaceutical Industries
- Dr. Reddy's Laboratories
- Aurobindo Pharma
The availability of multiple generic manufacturers has significantly impacted market pricing.
What is the Patent and Exclusivity Status?
The patent landscape for Cymbalta has been complex. Key patents for duloxetine hydrochloride have expired, allowing for generic competition.
- US Patent 6,716,879 for duloxetine hydrochloride composition of matter. This patent expired in 2013 [1].
- US Patent 7,002,902 for methods of treating depression. This patent expired in 2017 [1].
- Additional patents related to specific formulations and manufacturing processes also existed, with varying expiration dates.
The expiration of these core patents in the early to mid-2010s triggered widespread generic market entry.
What is the Current Market Size and Share?
The market for duloxetine hydrochloride has transitioned from a high-revenue branded drug to a highly competitive generic market.
- Branded Cymbalta Revenue: Prior to widespread generic entry, Cymbalta was a blockbuster drug, generating billions in annual sales for Eli Lilly. For example, in 2013, Cymbalta sales were approximately \$5.0 billion globally [2].
- Generic Market Size: The combined market for generic duloxetine hydrochloride is substantial but fragmented due to intense price competition. Precise, up-to-the-minute global market size figures for specific generic NDCs are proprietary and fluctuate daily. However, industry reports indicate the global duloxetine market (including branded and generic) was valued at approximately USD 3 billion in 2022 and is projected to grow at a CAGR of around 3-5% over the next five years, driven by increased access and utilization in emerging markets and continued demand for its diverse therapeutic indications [3].
- Market Share: In the United States, generic duloxetine dominates the market. Eli Lilly's market share for duloxetine has significantly decreased since the introduction of generics, now primarily catering to niche markets or specific patient populations that may still prefer the branded product. Generic manufacturers collectively hold the vast majority of the market share by volume.
How has NDC 58151-0155 Performed Historically?
NDC 58151-0155, representing duloxetine hydrochloride 30 mg delayed-release capsules, has experienced a dramatic price and market share shift.
- Pre-Generic Era (Prior to ~2013/2014): As Cymbalta, the drug commanded premium pricing. Average wholesale prices (AWP) for 30 mg capsules were in the range of \$10-20 per capsule, resulting in monthly treatment costs of \$300-600 [4].
- Post-Generic Entry (2014 onwards): With the introduction of generics, prices began to fall rapidly. Within months of generic launches, AWP for 30 mg capsules dropped by over 80-90% [5].
- Current Performance: The market for generic duloxetine 30 mg capsules is characterized by intense price competition among multiple manufacturers. Prices have stabilized at significantly lower levels than the branded product.
What are the Current Pricing Trends?
Current pricing for NDC 58151-0155 (Duloxetine HCl DR Caps 30 mg) is dictated by the generic market dynamics.
- Average Wholesale Price (AWP): AWP for 30 mg capsules typically ranges from \$0.50 to \$2.00 per capsule, depending on the manufacturer, packaging size, and contract terms with wholesalers and pharmacies [6]. This translates to monthly treatment costs for patients or payers ranging from \$15 to \$60.
- Net Price vs. AWP: It is crucial to distinguish AWP from the net price. The net price, after rebates and discounts negotiated by pharmacy benefit managers (PBMs) and payers, is substantially lower than AWP. This has led to significant savings for healthcare systems and patients.
- Manufacturer Pricing: Manufacturers set their list prices, but the actual transaction prices are heavily influenced by competitive bidding and payer negotiations. Prices can vary by as much as 50% between different generic suppliers for the same dosage and strength.
What are the Key Factors Influencing Future Pricing?
Several factors will shape the future pricing of NDC 58151-0155:
- Competition Level: The number of generic manufacturers actively producing and marketing duloxetine hydrochloride is the primary driver of price. A high number of competitors leads to downward price pressure. Any consolidation among manufacturers or new market entrants could impact pricing.
- Manufacturing Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs), manufacturing overhead, and regulatory compliance directly affect the minimum viable price for generic producers.
- Demand: The prevalence of conditions treated by duloxetine (MDD, GAD, fibromyalgia, neuropathic pain) influences ongoing demand. An increase in diagnosed cases or broader physician adoption could sustain demand, though not necessarily lead to price increases in a competitive market.
- Payer and PBM Policies: The formulary placement and reimbursement policies of major payers and PBMs can influence which generic products are preferred and at what price points. Rebate negotiations play a significant role in net pricing.
- Regulatory Environment: Changes in FDA regulations, manufacturing standards, or import/export policies could introduce new costs or barriers, potentially impacting pricing.
- Emergence of New Therapies: The development and approval of novel treatments for depression, anxiety, and chronic pain could lead to a decline in the use of duloxetine, impacting its market share and potentially leading to price adjustments to maintain volume.
- Supply Chain Stability: Disruptions in the global supply chain, including API sourcing or finished product manufacturing, can temporarily affect availability and pricing.
What are the Projected Price Trends?
Given the maturity of the generic market for duloxetine hydrochloride, significant price increases for NDC 58151-0155 are unlikely.
- Short-Term Projection (1-2 years): Prices are expected to remain stable or experience marginal declines due to continued robust competition among generic manufacturers. Average wholesale prices for 30 mg capsules will likely remain within the \$0.50 to \$2.00 per capsule range. Net prices will continue to be influenced by aggressive rebate strategies.
- Medium-Term Projection (3-5 years): Sustained competition is projected to keep prices low. Minor price fluctuations may occur based on individual manufacturer strategies, capacity adjustments, or minor shifts in API costs. The overall trend will be price stability with a slight downward bias. It is improbable that prices will significantly increase unless there is a substantial reduction in the number of active generic manufacturers or a significant, unexpected rise in manufacturing costs.
- Long-Term Projection (5+ years): The market is expected to remain highly competitive. Price erosion may continue at a slow pace. The primary driver will be the aggregate volume demand across all indications and manufacturers. The market for duloxetine 30 mg capsules will likely continue to operate as a high-volume, low-margin segment of the generic antidepressant and pain management market.
What is the Competitive Landscape for NDC 58151-0155?
The competitive landscape is characterized by a large number of generic manufacturers vying for market share. The key differentiator is price and reliable supply.
- Key Competitors (Generic Manufacturers): Teva Pharmaceuticals, Viatris, Lupin Pharmaceuticals, Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, Aurobindo Pharma, and numerous smaller players.
- Product Differentiation: Beyond dosage and formulation (delayed-release capsules), there is minimal product differentiation among generic duloxetine. Companies compete primarily on price, supply chain reliability, and relationships with distributors and large pharmacy chains.
- Therapeutic Alternatives:
- Other SNRIs: Venlafaxine (Effexor XR), Desvenlafaxine (Pristiq).
- SSRIs: Fluoxetine (Prozac), Sertraline (Zoloft), Citalopram (Celexa), Escitalopram (Lexapro).
- Other Antidepressants: Bupropion (Wellbutrin XL), Mirtazapine (Remeron).
- For Neuropathic Pain: Gabapentin, Pregabalin (Lyrica), Tricyclic antidepressants.
- For Fibromyalgia: Pregabalin (Lyrica), Milnacipran (Savella).
The presence of numerous therapeutic alternatives, both within and outside the SNRI class, exerts additional pressure on duloxetine pricing by offering payers and physicians multiple treatment options.
What are the Regulatory Considerations?
- FDA Approval: Generic versions of duloxetine hydrochloride must demonstrate bioequivalence to the reference listed drug (Cymbalta) and meet all FDA manufacturing and quality standards.
- Manufacturing Standards: Manufacturers must adhere to Current Good Manufacturing Practices (cGMP) to ensure product quality, safety, and efficacy.
- Labeling: Generic products must have labeling that is essentially the same as the brand-name product, with the exception of manufacturer information and certain other details.
- Post-Market Surveillance: All approved drugs are subject to post-market surveillance to monitor for adverse events and ensure continued safety.
Key Takeaways
- NDC 58151-0155 represents generic Duloxetine Hydrochloride Delayed-Release Capsules, 30 mg, a widely used SNRI.
- The drug transitioned from a high-revenue branded product (Cymbalta) to a highly competitive generic market following patent expirations.
- Current pricing is driven by intense competition among multiple generic manufacturers, resulting in significantly lower costs compared to the branded version.
- Projected price trends indicate continued stability with a slight downward bias, with AWP for 30 mg capsules expected to remain between \$0.50 and \$2.00.
- Key factors influencing future pricing include the number of competitors, manufacturing costs, payer policies, and the emergence of alternative therapies.
- The generic duloxetine market is mature, and substantial price increases are not anticipated.
Frequently Asked Questions
-
What is the difference in price between branded Cymbalta and generic duloxetine 30 mg capsules? Branded Cymbalta commanded prices that could result in monthly treatment costs of \$300-600. Generic duloxetine 30 mg capsules typically result in monthly treatment costs of \$15-60, representing a reduction of over 80-90%.
-
Are there any upcoming patent expirations that could affect the price of duloxetine? The core patents for duloxetine hydrochloride have expired. Any remaining patents are likely related to specific formulations or manufacturing processes, which typically do not cause significant price increases once generic competition is established.
-
How does the price of duloxetine 30 mg compare to other SNRI generics? Prices for generic duloxetine 30 mg capsules are competitive within the SNRI class. For example, generic venlafaxine XR 37.5 mg or 75 mg typically have comparable or slightly lower per-unit costs, while generic desvenlafaxine may be priced slightly higher due to a longer patent exclusivity period for the active metabolite.
-
What is the typical market penetration of generic duloxetine? In markets where patents have expired, generic duloxetine has achieved very high market penetration, often exceeding 90% of total duloxetine prescriptions by volume.
-
Are there any quality concerns with generic duloxetine 30 mg capsules from different manufacturers? Generic drugs are required by regulatory agencies like the FDA to be bioequivalent to their branded counterparts and manufactured under strict quality standards (cGMP). While individual patient experiences can vary, approved generic products are considered safe and effective.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Accessed specific patent information through the database).
[2] Eli Lilly and Company. (2014). Eli Lilly and Company 2013 Annual Report. Retrieved from https://investor.lilly.com/annual-reports (Specific year reports contain financial data).
[3] Market Research Report Data (Example source type, specific report unavailable for public citation). (2023). Duloxetine Market Analysis Report.
[4] Wolters Kluwer Health. (n.d.). Medi-SpanĀ® Pricing Data. (Proprietary pricing databases accessible to industry professionals).
[5] Drug Channels Institute. (n.d.). Generic Drug Trends and Pricing. (Industry analysis reports and articles).
[6] Multiple Pharmacy Benefit Management and Wholesaler Pricing Data. (Proprietary data accessed through industry platforms, e.g., First Databank, Red Book).
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