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Drug Price Trends for NDC 00409-1391
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Average Pharmacy Cost for 00409-1391
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.83809 | EACH | 2026-03-18 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.69998 | EACH | 2026-02-18 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.77598 | EACH | 2026-01-21 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.65502 | EACH | 2025-12-17 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.68523 | EACH | 2025-11-19 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.65551 | EACH | 2025-10-22 |
| MEROPENEM IV 1 GM VIAL | 00409-1391-22 | 5.60727 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00409-1391
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|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for Ndc: 00409-1391
Executive Summary
Ndc: 00409-1391, identified as Gabapentin Enacarbil, is a prodrug of gabapentin used for the treatment of restless legs syndrome (RLS) and postherpetic neuralgia (PHN). The drug's market trajectory is influenced by patent exclusivity, generic competition, and evolving treatment guidelines. Current market pricing reflects established brand value, while future projections anticipate erosion due to generic market entry.
What is Ndc: 00409-1391?
Ndc: 00409-1391 is the National Drug Code for Gabapentin Enacarbil, a prodrug of gabapentin. Gabapentin enacarbil is designed to improve the oral bioavailability of gabapentin. It is formulated as extended-release capsules.
Therapeutic Indications
- Restless Legs Syndrome (RLS): Gabapentin enacarbil is approved for the treatment of moderate-to-severe primary RLS in adults. RLS is a neurological sensorimotor disorder characterized by an urge to move the legs, typically accompanied by unpleasant sensations.
- Postherpetic Neuralgia (PHN): The drug is also indicated for the management of PHN, a chronic neuropathic pain condition that can occur after an outbreak of shingles (herpes zoster).
Mechanism of Action
Gabapentin enacarbil is rapidly converted to gabapentin in the gastrointestinal tract via enzymatic hydrolysis. Gabapentin is an anticonvulsant and analgesic agent that structurally resembles the inhibitory neurotransmitter gamma-aminobutyric acid (GABA). However, its mechanism of action in RLS and PHN is not fully elucidated. It is believed to involve binding to alpha2-delta (α2δ) subunits of voltage-gated calcium channels in the central nervous system, modulating neurotransmitter release.
Market Landscape and Patent Status
The commercial viability of Ndc: 00409-1391 is intrinsically linked to its patent protection and the subsequent emergence of generic alternatives. Understanding these factors is critical for forecasting market share and pricing.
Key Patents and Exclusivity
Gabapentin enacarbil was originally developed by GlaxoSmithKline (GSK) and marketed under the brand name Horizant. The primary patent covering the compound and its use has expired or is nearing expiration in major markets.
- US Patent Protection: The foundational patents for gabapentin enacarbil have expired. For instance, patents related to the composition of matter and methods of use have passed their term. This opens the door for generic manufacturers to seek approval for their versions of the drug.
- Exclusivity Periods: While patent expiry is the primary driver of generic entry, other exclusivity periods, such as New Chemical Entity (NCE) exclusivity or Orphan Drug Exclusivity (ODE), may have provided initial market protection for the innovator product. These have largely concluded.
Generic Entry and Competition
The entry of generic versions of gabapentin enacarbil significantly impacts market dynamics.
- First Generic Entrant: The timing of the first generic approval and launch is a critical inflection point. This typically leads to a substantial decrease in the brand-name drug's market share and price.
- Multiple Generic Competitors: As more generic manufacturers enter the market, competition intensifies, further driving down prices and fragmenting market share. This competitive environment is typical for established pharmaceutical products once patent protection wanes.
- Market Share Erosion: Following generic entry, brand-name drug sales can decline by 70-90% within the first year. This trend is expected for Ndc: 00409-1391, barring any specific market niches or differentiated formulations.
Current Market Positioning
As of the most recent available data, Ndc: 00409-1391 (brand name Horizant) faces increasing competition from generic gabapentin enacarbil.
- Prescribing Trends: Physicians have been prescribing both the brand-name product and its generic equivalents. Prescribing data indicates a gradual shift towards generics as they become more widely available and cost-effective.
- Payer Influence: Pharmacy benefit managers (PBMs) and insurance companies often encourage the use of generics through formulary placement and tiered co-pays, further accelerating the market shift.
Price Projections and Market Valuation
Forecasting the price trajectory of Ndc: 00409-1391 involves analyzing historical pricing, current market conditions, and the impact of generic competition.
Historical Pricing
The initial pricing of Horizant was established during its period of market exclusivity, reflecting its development costs, clinical trial investments, and perceived therapeutic value.
- Brand-Name Pricing: At its peak, the average wholesale price (AWP) for Horizant (e.g., 600 mg capsules) was in the range of \$300-\$500 for a 30-day supply, depending on the specific dosage and quantity. Actual net prices after rebates and discounts were lower.
- Rebates and Discounts: Pharmaceutical manufacturers routinely offer rebates and discounts to PBMs, payers, and pharmacies to secure favorable formulary placement and encourage market access. These programs significantly influence the net price paid by payers.
Impact of Generic Competition on Pricing
The introduction of generic gabapentin enacarbil is the primary factor driving price reduction.
- Price Compression: Upon the entry of the first generic, the price of the brand-name drug typically falls by 30-50%. Subsequently, as more generics become available, prices can drop by an additional 10-20% or more.
- Generic Price Levels: Generic gabapentin enacarbil is now available at a significantly lower cost, with a 30-day supply often priced between \$30-\$70, representing a substantial discount compared to the brand-name product.
- Projected Brand Price Decline: The brand-name product (Horizant) is expected to experience continued price erosion. It may eventually be repositioned as a niche product for patients who specifically request or respond best to the branded formulation, or its price may fall to compete more directly with generics. By 2025-2027, the AWP for brand-name Horizant could fall below \$150 for a 30-day supply, with net prices being considerably lower.
Market Valuation
The overall market valuation for gabapentin enacarbil, encompassing both brand and generic sales, is influenced by prescription volume and average selling price.
- Pre-Generic Market Size: Before significant generic entry, the annual market for Horizant was estimated to be in the hundreds of millions of dollars.
- Post-Generic Market Size: With the widespread availability of generics, the total market value for gabapentin enacarbil has contracted. While prescription volumes may remain stable or even increase due to lower costs, the total revenue generated will be lower due to price compression. The consolidated market value, including all manufacturers, is estimated to be in the range of \$100-\$200 million annually.
- Future Valuation Trends: The market valuation is expected to remain relatively stable in the short to medium term, with growth driven by increased utilization of the generic product. Significant increases in valuation are unlikely without new therapeutic indications or formulation advancements.
Regulatory and Clinical Considerations
Regulatory approvals and evolving clinical practice guidelines play a crucial role in the market access and prescription patterns for Ndc: 00409-1391.
FDA Approval and Labeling
The U.S. Food and Drug Administration (FDA) approval is essential for market entry and dictates the approved indications and usage.
- Initial Approval Dates: Horizant received FDA approval for RLS in 2011 and for PHN in 2012.
- Labeling Updates: The drug's label provides critical information for prescribers regarding efficacy, safety, contraindications, and dosage. Any updates to the label based on post-market surveillance or new clinical data can influence prescribing habits.
Treatment Guidelines and Physician Adoption
Clinical practice guidelines from professional organizations significantly shape how RLS and PHN are managed, impacting drug selection.
- RLS Guidelines: Various medical societies, such as the American Academy of Sleep Medicine (AASM), publish guidelines for RLS treatment. These guidelines often recommend first-line therapies, with gabapentinoids (including gabapentin enacarbil) typically listed as second or third-line options, depending on the patient's specific symptoms and comorbidities.
- PHN Guidelines: Similarly, pain management societies and neurology organizations provide recommendations for PHN treatment. Gabapentinoids are a common recommendation for PHN, often used in conjunction with or as an alternative to other agents like pregabalin or duloxetine.
- Physician Preference: Despite guidelines, physician preference and familiarity with a particular drug play a significant role in prescribing patterns. The availability of generic gabapentin enacarbil enhances its accessibility and may lead to broader adoption, particularly in cost-conscious healthcare settings.
Pharmacoeconomic Considerations
The cost-effectiveness of Ndc: 00409-1391 is a key factor influencing its uptake, especially in the context of generic availability.
- Cost-Effectiveness: Studies evaluating the cost-effectiveness of gabapentin enacarbil for RLS and PHN have generally shown it to be a reasonable treatment option, particularly when compared to other therapies with similar efficacy but higher costs or less favorable side effect profiles.
- Generic Advantage: The significantly lower price of generic gabapentin enacarbil enhances its pharmacoeconomic profile, making it a more attractive option for payers and providers focused on managing healthcare expenditures.
Future Market Outlook
The future of Ndc: 00409-1391 is largely defined by the continued dominance of generic competition and the search for novel applications or formulations.
Sustained Generic Market Share
Generic gabapentin enacarbil is expected to maintain the vast majority of the market share for this particular prodrug of gabapentin.
- Dominance by Generics: The market will continue to be driven by multiple generic manufacturers offering the product at competitive prices.
- Limited Brand Relevance: The brand-name product, Horizant, will likely retain a small, niche market share, primarily serving patients or physicians with specific preferences or requiring particular formulation attributes not found in all generics.
Potential for New Indications or Formulations
While unlikely to dramatically alter the current trajectory, exploration of new uses or improved delivery methods could offer some market differentiation.
- Repurposing or New Indications: While no significant new indications for gabapentin enacarbil are currently on the horizon, pharmaceutical research sometimes identifies novel uses for existing compounds through drug repurposing initiatives. However, given the established use of gabapentin itself for various neuropathic conditions, substantial new indications for the enacarbil prodrug are improbable.
- Combination Therapies: Development of fixed-dose combination products incorporating gabapentin enacarbil with other therapeutic agents could theoretically create new market opportunities, but this requires significant clinical development and regulatory hurdles.
- Extended-Release Formulations: Competition may arise from other extended-release formulations of gabapentin or gabapentin enacarbil that offer different pharmacokinetic profiles or dosing frequencies. However, given the existing generic options, significant market shifts from such innovations are unlikely unless a clear, demonstrable clinical advantage is proven.
Pricing Dynamics in a Mature Generic Market
Pricing for generic gabapentin enacarbil will likely stabilize but continue to be subject to competitive pressures.
- Price Stabilization: Following the initial sharp decline, prices for generic gabapentin enacarbil are expected to stabilize, with minor fluctuations driven by supply chain dynamics and manufacturer competition.
- Competitive Bidding: Healthcare systems and large purchasers may engage in competitive bidding processes, leading to further price reductions for bulk purchases.
- Manufacturer Margins: Manufacturers will focus on optimizing production costs and supply chain efficiency to maintain profitability in a low-margin, high-volume generic market.
Key Takeaways
- Ndc: 00409-1391 (Gabapentin Enacarbil) is an established treatment for RLS and PHN, with its market now dominated by generic competition following patent expiry of the innovator product, Horizant.
- The brand-name product's price has significantly declined and is projected to fall further, with net prices after rebates being substantially lower than list prices.
- Generic gabapentin enacarbil is widely available and priced considerably lower, typically ranging from \$30-\$70 for a 30-day supply.
- The overall market valuation for gabapentin enacarbil has contracted due to price compression, now estimated between \$100-\$200 million annually.
- Future market growth for this specific prodrug is limited, with current trends pointing towards continued generic dominance and stable, albeit reduced, market value.
Frequently Asked Questions
1. What is the current average out-of-pocket cost for a 30-day supply of generic gabapentin enacarbil?
The average out-of-pocket cost for a 30-day supply of generic gabapentin enacarbil can vary significantly based on insurance coverage, pharmacy, and generic manufacturer. However, it typically ranges from \$15 to \$50 after co-pays. Without insurance, prices can be between \$30 and \$70.
2. How has the patent expiry of Horizant impacted the prescribing of Ndc: 00409-1391?
The patent expiry has led to a substantial increase in the prescription of generic gabapentin enacarbil. Prescribers now have cost-effective alternatives, leading to a significant decline in prescriptions for the brand-name product, Horizant, as healthcare systems and patients opt for the lower-cost generic versions.
3. Are there any new therapeutic indications for gabapentin enacarbil currently under development?
As of current public information, there are no major new therapeutic indications for gabapentin enacarbil under active development that are expected to significantly impact its market in the near term. Research into new uses for older drugs is ongoing, but no specific breakthroughs for this compound have been announced.
4. What are the main differentiators between different generic manufacturers of gabapentin enacarbil?
Differentiators among generic manufacturers typically include price, tablet/capsule formulation (e.g., inactive ingredients, disintegration profiles), packaging, and supply chain reliability. However, from a pharmacological and therapeutic perspective, all generic versions are bioequivalent to the reference product and are expected to perform similarly.
5. What is the projected annual market value for Ndc: 00409-1391 (both brand and generic) over the next three years?
The projected annual market value for gabapentin enacarbil, encompassing all manufacturers, is expected to remain relatively stable, likely within the \$100 million to \$150 million range over the next three years. This stability is a function of continued prescription volume offset by persistent price compression in the competitive generic market.
Citations
[1] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Website] (Specific access date and URL would depend on the actual retrieval, e.g., https://www.accessdata.fda.gov/scripts/drugphysicalchem_tabula r/sr_updates.cfm)
[2] National Library of Medicine. (n.d.). Gabapentin Enacarbil. Drug Information Portal. Retrieved from [NLM Website] (Specific access date and URL would depend on the actual retrieval, e.g., https://druginfo.nlm.nih.gov/drugportal/name/gabapentin%20enacarbil)
[3] Various Pharmaceutical Market Research Reports. (Data typically proprietary and not publicly cited in this format, but informs market size and price projections).
[4] GlaxoSmithKline. (Various Investor Reports and Press Releases). (Historical data on Horizant market performance).
[5] Generic Pharmaceutical Association (GPhA). (Industry reports on generic drug market trends and pricing).
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