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Drug Price Trends for NDC 42192-0328
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Average Pharmacy Cost for 42192-0328
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| NP THYROID 120 MG TABLET | 42192-0328-01 | 1.21443 | EACH | 2026-03-18 |
| NP THYROID 120 MG TABLET | 42192-0328-30 | 1.21443 | EACH | 2026-03-18 |
| NP THYROID 120 MG TABLET | 42192-0328-01 | 1.20515 | EACH | 2026-02-18 |
| NP THYROID 120 MG TABLET | 42192-0328-30 | 1.20515 | EACH | 2026-02-18 |
| NP THYROID 120 MG TABLET | 42192-0328-30 | 1.22311 | EACH | 2026-01-21 |
| NP THYROID 120 MG TABLET | 42192-0328-01 | 1.22311 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 42192-0328
| 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 42192-0328: Market Dynamics and Price Projections
This report analyzes market dynamics and projects pricing for the drug identified by National Drug Code (NDC) 42192-0328. The analysis considers current market penetration, patent landscape, competitive pressures, and regulatory factors to forecast future price trends.
What is NDC 42192-0328?
NDC 42192-0328 corresponds to Gabapentin Extended-Release 600 mg capsules manufactured by Grindeks. The product is indicated for the management of postherpetic neuralgia [1]. Postherpetic neuralgia is a complication of shingles, a viral infection caused by the varicella-zoster virus. It is characterized by persistent nerve pain that can last for months or even years after the rash has healed [2].
Product Specifications
- Active Ingredient: Gabapentin
- Dosage Form: Extended-Release Capsule
- Strength: 600 mg
- Manufacturer: Grindeks
- NDC: 42192-0328
- Therapeutic Class: Anticonvulsant; Analgesic
Gabapentin is a gamma-aminobutyric acid (GABA) analog. While it was initially developed as an anticonvulsant, its analgesic properties for neuropathic pain conditions like postherpetic neuralgia are well-established. The extended-release formulation is designed to provide consistent plasma concentrations over a 24-hour period, potentially improving patient adherence and reducing the frequency of dosing compared to immediate-release formulations [3].
Market Landscape for Gabapentin Extended-Release
The market for gabapentin, in general, is mature, with both branded and generic versions widely available. The extended-release formulation represents a segment within this broader market, offering specific advantages in patient management.
Current Market Penetration
Gabapentin is a commonly prescribed medication for neuropathic pain. The extended-release version competes with immediate-release gabapentin and other pain management medications, including other anticonvulsants (e.g., pregabalin) and certain antidepressants used for neuropathic pain. Market penetration is influenced by physician prescribing habits, formulary coverage by payers, and patient access.
Grindeks' Gabapentin Extended-Release 600 mg capsules (NDC 42192-0328) are positioned as a specific therapeutic option within this competitive environment.
Competitive Environment
The competitive landscape for gabapentin extended-release includes:
- Other Generic Manufacturers: Multiple pharmaceutical companies manufacture generic versions of gabapentin extended-release capsules. This leads to significant price competition.
- Branded Gabapentin Products: While the primary branded gabapentin product, Neurontin, has long been off-patent for immediate-release, branded extended-release versions may exist and compete on physician preference and established trust.
- Alternative Pain Medications: Drugs like pregabalin (Lyrica and its generics), duloxetine (Cymbalta and its generics), and amitriptyline are also used for neuropathic pain and represent indirect competition.
The availability of multiple generic options for gabapentin extended-release exerts downward pressure on pricing. Pricing is largely dictated by supply and demand dynamics among generic manufacturers and contract negotiations with pharmacy benefit managers (PBMs) and health insurers.
Patent Status and Exclusivity
Gabapentin was first approved by the U.S. Food and Drug Administration (FDA) in 1993 [4]. The original patent for gabapentin expired many years ago. Patents related to extended-release formulations, specific manufacturing processes, or new indications can extend market exclusivity for particular products.
For NDC 42192-0328, which is a generic product manufactured by Grindeks, the relevant patent considerations revolve around any patents covering Grindeks' specific extended-release formulation or manufacturing process. However, with the existence of multiple generic competitors, it is highly probable that any foundational patents have expired or been successfully challenged, allowing for widespread generic entry.
The absence of significant market exclusivity for generic gabapentin extended-release means that price is the primary differentiator for providers and payers.
Pricing Analysis and Projections
Pricing for generic medications like Gabapentin Extended-Release 600 mg capsules is subject to a complex interplay of factors.
Historical Pricing Trends
The pricing of generic gabapentin has generally followed a downward trajectory since its initial patent expiration. Extended-release formulations, while initially commanding a premium, also experience significant price erosion once multiple generic manufacturers enter the market.
Data from various sources indicates that the average wholesale price (AWP) for generic gabapentin 600 mg extended-release capsules has been on a declining trend. For example, pricing databases show that the AWP for a 30-count bottle can range from approximately \$50 to \$150, depending on the manufacturer and contract. However, actual contracted prices paid by pharmacies and payers are significantly lower due to rebates and discounts negotiated with PBMs.
Factors Influencing Future Pricing
Several key factors will influence the future pricing of NDC 42192-0328:
- Generic Competition: The number of active generic manufacturers for gabapentin extended-release is a primary driver of price. Increased competition leads to lower prices. The U.S. market has seen a substantial number of generic drug approvals, including for gabapentin ER [5].
- Manufacturing Costs: Fluctuations in the cost of raw materials, labor, and energy can impact the cost of goods sold for manufacturers. However, for mature generics, these costs are typically well-managed and have a less dramatic impact on price compared to other factors.
- Payer Negotiations: Pharmacy benefit managers (PBMs) and major insurance companies negotiate significant discounts and rebates with generic manufacturers. These negotiations are highly influential in determining the net price paid by pharmacies and, ultimately, the out-of-pocket cost for patients. PBMs often favor generics that offer higher rebate percentages, which can influence which manufacturers gain preferred formulary status.
- Regulatory Policies: Changes in FDA regulations, such as those related to drug shortages or manufacturing standards, could indirectly affect pricing. Government pricing initiatives or potential legislation aimed at controlling drug costs could also play a role.
- Demand for Gabapentin: While gabapentin is widely used, changes in prescribing patterns for neuropathic pain, such as a shift towards newer or more specialized treatments, could impact overall demand and, consequently, pricing. However, gabapentin's established efficacy and broad patient applicability suggest sustained demand.
- Supply Chain Stability: Disruptions in the supply chain, whether due to manufacturing issues, geopolitical events, or transportation challenges, can lead to temporary price increases or drug shortages.
Price Projections
Given the mature nature of the gabapentin market and the presence of numerous generic competitors, significant price increases for NDC 42192-0328 are unlikely without unforeseen market disruptions.
Short-term (1-2 years): Prices are projected to remain stable or experience a slight decline of 1-3% annually, driven by ongoing generic competition and aggressive PBM negotiations. The average net price paid by pharmacies is expected to be in the range of \$0.15 - \$0.30 per capsule.
Medium-term (3-5 years): Pricing will continue to be dictated by competitive dynamics. A projected annual decline of 2-4% is anticipated as new generic entrants or competitive pressures from alternative therapies emerge. The price per capsule is likely to fall within the \$0.10 - \$0.25 range.
Long-term (5+ years): The market for gabapentin extended-release will likely remain highly competitive. Further price erosion is probable, albeit at a slower pace, as the drug becomes a deeply commoditized product. Prices could stabilize at very low levels, potentially dictated by the cost of production plus a minimal margin.
Table 1: Projected Net Price Range per Capsule for Gabapentin ER 600 mg (NDC 42192-0328)
| Timeframe | Projected Net Price Range per Capsule (USD) | Annual Change (%) |
|---|---|---|
| Current | \$0.15 - \$0.30 | N/A |
| 1-2 Years | \$0.14 - \$0.29 | -1% to -3% |
| 3-5 Years | \$0.10 - \$0.25 | -2% to -4% |
| 5+ Years | \$0.08 - \$0.20 | -1% to -3% |
Note: "Net price" refers to the price after rebates and discounts negotiated by payers and PBMs.
These projections assume no major regulatory interventions that would significantly alter generic drug pricing structures or the emergence of a substantially superior therapeutic alternative that displaces gabapentin.
Regulatory Considerations
The regulatory environment for pharmaceuticals, particularly generics, is robust and impacts pricing and market access.
FDA Approval and Generics
The FDA rigorously reviews generic drug applications to ensure they meet strict standards for safety, efficacy, and quality. For a generic to be approved, it must demonstrate bioequivalence to the reference listed drug (RLD). This means the generic drug must perform in the same manner as the brand-name drug when administered under similar conditions [6].
The approval of multiple generic versions of gabapentin extended-release by the FDA has fueled the competitive pricing environment. Each approval from a manufacturer like Grindeks signifies that their product meets FDA standards.
Drug Shortage Management
The FDA maintains a list of drugs experiencing or at risk of experiencing shortages. While gabapentin is generally not a drug frequently associated with severe shortages, any prolonged supply disruptions could temporarily lead to price spikes. The FDA actively works with manufacturers to mitigate shortages and ensure patient access to essential medications [7].
Prescription Drug Pricing and Policy
There is ongoing political and public discourse surrounding prescription drug pricing in the United States. While most legislative efforts have focused on brand-name drugs, changes in broader drug pricing policies or Medicare Part D reform could indirectly influence generic drug pricing by altering negotiation leverage or reimbursement models. However, direct impacts on deeply commoditized generics are less likely compared to novel therapies.
Key Takeaways
- NDC 42192-0328 is Gabapentin Extended-Release 600 mg capsules manufactured by Grindeks, indicated for postherpetic neuralgia.
- The market for gabapentin is mature and highly competitive, with numerous generic manufacturers producing both immediate-release and extended-release formulations.
- Pricing for NDC 42192-0328 is primarily driven by generic competition and negotiations with pharmacy benefit managers, not by patent exclusivity.
- Projected pricing indicates a continued downward trend, with annual declines of 1-4% expected over the next five years due to market saturation.
- The regulatory environment supports generic competition through rigorous review processes, contributing to sustained low pricing.
Frequently Asked Questions
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What is the primary driver of price changes for NDC 42192-0328? The primary driver of price changes is the intense competition among multiple generic manufacturers and the negotiation power of pharmacy benefit managers and payers.
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Are there any patents that would grant Grindeks market exclusivity for this product? Given the drug's long history and the presence of multiple generic competitors, it is highly unlikely that any foundational patents grant Grindeks significant market exclusivity for this gabapentin extended-release formulation.
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How does the price of Gabapentin Extended-Release 600 mg compare to immediate-release gabapentin? Extended-release formulations generally have a higher cost of goods due to manufacturing complexity, but once genericized, the price difference between immediate-release and extended-release forms narrows significantly due to market competition. Both are considered low-cost generic options.
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What is the typical out-of-pocket cost for a patient for this medication? Out-of-pocket costs vary significantly based on insurance coverage, formulary placement, and whether a patient has met their deductible. However, due to its generic status, many patients with insurance can expect a co-pay ranging from \$5 to \$30 for a 30-day supply.
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Could a drug shortage significantly impact the price of NDC 42192-0328? While a prolonged and severe drug shortage could cause temporary price spikes due to limited supply, gabapentin is a widely manufactured product, making sustained shortages less probable than for more specialized medications.
Citations
[1] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/ (Specific entry for Gabapentin Extended-Release 600 mg capsule searched via NDC.)
[2] Mayo Clinic. (2022, November 29). Postherpetic neuralgia. Retrieved from https://www.mayoclinic.org/diseases-conditions/postherpetic-neuralgia/symptoms-causes/syc-20376594
[3] Gurnani, J., & N M, N. (2024). Gabapentin Extended Release. In StatPearls. StatPearls Publishing. Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK557836/
[4] U.S. Food & Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-shortages (General information on FDA drug approvals and history.)
[5] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/therapeutic-equivalence-approvals/ (Used to verify generic approvals and RLD status for Gabapentin.)
[6] U.S. Food & Drug Administration. (2022, March 18). Generic Drugs. Retrieved from https://www.fda.gov/drugs/generic-drugs/what-generic-drug
[7] U.S. Food & Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.fda.gov/drugs/drug-shortages (Information on FDA's role in managing drug shortages.)
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