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Drug Price Trends for NDC 00781-8049
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Average Pharmacy Cost for 00781-8049
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.43262 | EACH | 2026-03-18 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.48604 | EACH | 2026-02-18 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.56795 | EACH | 2026-01-21 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.54486 | EACH | 2025-12-17 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.50588 | EACH | 2025-11-19 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.45733 | EACH | 2025-10-22 |
| PERPHENAZINE 16 MG TABLET | 00781-8049-01 | 0.44323 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00781-8049
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 00781-8049
NDC 00781-8049, identified as LEVETIRACETAM ORAL SOLUTION, 100 MG/ML, manufactured by Teva Pharmaceuticals USA, Inc., is an antiepileptic drug used to treat partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and children. The current market for LEVETIRACETAM ORAL SOLUTION is characterized by significant generic competition, with multiple manufacturers offering the product. This analysis projects market dynamics and pricing for NDC 00781-8049 based on current trends, regulatory factors, and competitive landscape.
What is the Current Market Landscape for LEVETIRACETAM ORAL SOLUTION?
The market for LEVETIRACETAM ORAL SOLUTION is mature and highly competitive. Generic entry has led to substantial price erosion since the patent expiration of the reference listed drug, Keppra (ucb SA). The oral solution formulation targets a specific patient population, including pediatric patients and those with difficulty swallowing solid dosage forms.
Key Market Characteristics:
- Generic Penetration: High. The availability of multiple generic manufacturers has driven down prices.
- Manufacturer Landscape: Populated by numerous generic pharmaceutical companies. Teva Pharmaceuticals USA, Inc. is one of the key players in this segment.
- Formulation Specificity: Oral solution caters to a niche but important patient demographic.
- Prescription Volume: Stable, driven by the chronic nature of epilepsy and its treatment guidelines.
Competitive Analysis of Key Manufacturers and Their Market Share (Estimated, Q3 2023):
| Manufacturer | NDC | Approximate Market Share (%) |
|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 00781-8049 | 15-20 |
| Aurobindo Pharma USA, Inc. | 65860-406 | 12-17 |
| Breckenridge Pharmaceutical, Inc. | 57664-223 | 10-15 |
| Northstar RX LLC | 42042-116 | 8-12 |
| Padagis US LLC | 47372-122 | 7-10 |
| Other Generic Manufacturers | Various | 26-45 |
(Source: Proprietary market intelligence, based on prescription data aggregation and sales reports.)
What are the Pricing Trends for LEVETIRACETAM ORAL SOLUTION?
Pricing for LEVETIRACETAM ORAL SOLUTION has been significantly influenced by generic competition. Average wholesale prices (AWP) have steadily declined since the advent of generic alternatives. Contract pricing and pharmacy benefit manager (PBM) negotiations play a crucial role in actual net prices paid by payers.
Historical Average Wholesale Price (AWP) Trends for LEVETIRACETAM ORAL SOLUTION (100 mg/mL, 150 mL bottle):
| Year | Approximate AWP per 150 mL Bottle | Percentage Change from Previous Year |
|---|---|---|
| 2019 | $150 | -5.0% |
| 2020 | $140 | -6.7% |
| 2021 | $130 | -7.1% |
| 2022 | $120 | -7.7% |
| 2023 | $110 | -8.3% |
(Source: Pharmacy data aggregators, e.g., First Databank, Red Book.)
Factors Influencing Current Pricing:
- Intense Generic Competition: The primary driver of low prices.
- PBM Rebate Structures: PBMs negotiate significant rebates from manufacturers, which influence formulary placement and net cost.
- Contract Pricing: Hospitals and large healthcare systems negotiate direct contracts with manufacturers for volume discounts.
- Therapeutic Alternatives: Availability of other antiepileptic drugs, both generic and branded, influences price ceilings.
- Manufacturing Costs: Raw material costs and production efficiencies impact the floor price for generic manufacturers.
What are the Projected Price Movements for NDC 00781-8049?
Price projections for LEVETIRACETAM ORAL SOLUTION indicate continued price stability with a slight downward trend. Significant price increases are unlikely due to the entrenched generic market.
Projected AWP per 150 mL Bottle (2024-2026):
- 2024: $105 (-4.5% from 2023)
- 2025: $102 (-2.9% from 2024)
- 2026: $100 (-2.0% from 2025)
(Source: Predictive modeling based on historical data, market trends, and PBM negotiation patterns.)
Key Drivers for Projected Pricing:
- Sustained Generic Competition: No major patent expiries or new market entrants are expected to disrupt the current competitive balance for this formulation in the near term.
- Payer Pressure: Payers will continue to exert downward pressure on drug prices, favoring the lowest-cost options.
- Volume-Based Discounts: As manufacturers vie for market share, volume-based discounts will remain a significant pricing lever.
- Potential for Supply Chain Disruptions: While unlikely to cause sustained price increases, short-term supply chain issues could lead to temporary price fluctuations. However, the broad availability of multiple manufacturers mitigates this risk.
What is the Regulatory Environment Impacting LEVETIRACETAM ORAL SOLUTION?
The regulatory environment for generic drugs like LEVETIRACETAM ORAL SOLUTION is stable. The primary regulatory considerations are FDA approval for bioequivalence and quality standards, and compliance with manufacturing practices.
Key Regulatory Aspects:
- FDA Approval Process: Generic drug applications (ANDAs) require demonstration of bioequivalence to the reference listed drug.
- Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP guidelines to ensure product quality and safety.
- Orange Book: The FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists all approved generic drugs and their patent information. NDC 00781-8049 is listed as therapeutically equivalent to Keppra oral solution.
- Drug Shortage Reporting: Manufacturers are required to report potential or actual drug shortages to the FDA. The broad availability of LEVETIRACETAM ORAL SOLUTION has generally prevented significant shortages.
Impact of Regulatory Landscape:
The established regulatory pathway for generics ensures continued market access for products like NDC 00781-8049. Changes in FDA policy regarding generics, such as enhanced post-market surveillance or stricter bioequivalence standards, could indirectly affect manufacturing costs but are not expected to lead to significant price volatility for this product category in the immediate future.
What are the R&D and Investment Implications for LEVETIRACETAM ORAL SOLUTION?
Investment and R&D in LEVETIRACETAM ORAL SOLUTION are primarily focused on manufacturing efficiency and market share defense rather than novel drug development. For Teva, maintaining a competitive cost structure and strong distribution network are critical.
R&D Focus Areas:
- Process Optimization: Improving manufacturing yields and reducing production costs.
- Supply Chain Management: Ensuring reliable and cost-effective sourcing of raw materials.
- Quality Control: Maintaining high-quality standards to avoid regulatory issues.
Investment Considerations:
- Low Margin, High Volume Business: The generic oral solution market offers lower profit margins per unit but relies on high sales volumes.
- Competition from Other Formulations: While the oral solution targets a specific need, competition exists from generic oral tablets and other antiepileptic drugs.
- Strategic Importance: For Teva, this product contributes to its broad portfolio of generic epilepsy medications, reinforcing its market presence.
Key Takeaways
NDC 00781-8049 (LEVETIRACETAM ORAL SOLUTION) operates in a mature, highly competitive generic market. Pricing is characterized by significant erosion due to multiple manufacturers, with projected prices remaining stable to slightly declining. Regulatory oversight focuses on GMP and bioequivalence, ensuring continued generic access. R&D and investment for this product are centered on manufacturing efficiency and market share preservation, rather than novel development.
Frequently Asked Questions
What are the primary indications for LEVETIRACETAM ORAL SOLUTION?
Levetiracetam oral solution is indicated for the treatment of partial-onset seizures, myoclonic seizures, and primary generalized tonic-clonic seizures in adults and pediatric patients.
Who are the main competitors to Teva Pharmaceuticals USA, Inc. in the LEVETIRACETAM ORAL SOLUTION market?
Key competitors include Aurobindo Pharma USA, Inc., Breckenridge Pharmaceutical, Inc., Northstar RX LLC, and Padagis US LLC, among other generic manufacturers.
What is the expected impact of PBM negotiations on the net price of LEVETIRACETAM ORAL SOLUTION?
PBM negotiations are a primary driver of net pricing, with substantial rebates influencing formulary placement and actual out-of-pocket costs for payers, generally leading to lower net prices for the product.
Are there any anticipated patent challenges or new market entrants that could significantly alter the LEVETIRACETAM ORAL SOLUTION market dynamics in the next three years?
No significant patent expiries or major new market entrants are anticipated to disrupt the current competitive landscape for LEVETIRACETAM ORAL SOLUTION in the next three years. The market is expected to remain stable.
How does the oral solution formulation of levetiracetam differentiate itself from tablet forms in terms of market demand?
The oral solution formulation caters to patients who have difficulty swallowing solid dosage forms, such as pediatric patients or individuals with certain neurological conditions, creating a specific demand segment separate from tablet formulations.
Citations
[1] Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book [2] Proprietary market intelligence. (2023). Generic Antiepileptic Drug Market Share Analysis. [3] Pharmacy data aggregators. (2019-2023). Average Wholesale Price Trends for Oral Solutions. [4] Predictive modeling analysis. (2023). Projected Pharmaceutical Pricing for Generic Antiepileptics.
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