Drug Price Trends for NDC 00143-9621

Average Pharmacy Cost for 00143-9621

Drug Name	NDC	Price/Unit ($)	Unit	Date
CYANOCOBALAMIN 1,000 MCG/ML VL	00143-9621-25	1.50210	ML	2026-03-18
CYANOCOBALAMIN 1,000 MCG/ML VL	00143-9621-25	1.52535	ML	2026-02-18
CYANOCOBALAMIN 1,000 MCG/ML VL	00143-9621-25	1.57560	ML	2026-01-21

Best Wholesale Price for NDC 00143-9621

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
CYANOCOBALAMIN 1000MCG/ML INJ	Hikma Pharmaceuticals USA Inc.	00143-9621-25	1ML	71.65	71.65000	2021-08-15 - 2026-08-14	FSS
CYANOCOBALAMIN 1000MCG/ML INJ	Hikma Pharmaceuticals USA Inc.	00143-9621-25	1ML	60.22	60.22000	2021-10-08 - 2026-08-14	FSS

Market Analysis and Price Projections for NDC 00143-9621

Last updated: February 19, 2026

NDC 00143-9621, Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL, manufactured by Alembic Pharmaceuticals, Inc., exhibits a stable market position with modest growth potential. Current pricing is competitive, driven by generic availability. Future price trajectory is expected to be influenced by manufacturing costs, regulatory shifts, and the emergence of potential therapeutic alternatives.

What is the Current Market Size and Segmentation for Clindamycin Hydrochloride Oral Solution (NDC 00143-9621)?

The market for Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL, is primarily segmented by therapeutic indication and payer type.

• Therapeutic Indications:

  • Bacterial infections: This is the dominant segment. Clindamycin is used to treat a range of bacterial infections, including those of the respiratory tract, skin and soft tissue, intra-abdominal infections, and bone and joint infections. Its efficacy against anaerobic bacteria and certain Gram-positive aerobes makes it a valuable agent.
  • Pneumocystis pneumonia prophylaxis: In immunocompromised patients, particularly those with HIV/AIDS, clindamycin can be used for prophylaxis.
  • Toxoplasmosis: In combination with pyrimethamine, clindamycin is an option for treating toxoplasmosis.

• Payer Type:

  • Commercial insurance: This segment represents a significant portion of market share, with private insurers covering a substantial volume of prescriptions.
  • Government programs (Medicare/Medicaid): These programs also contribute to market volume, particularly for pediatric populations and vulnerable adult groups.
  • Out-of-pocket: A smaller but consistent segment, comprising patients without insurance or those opting for direct purchase.

The specific market size for NDC 00143-9621 is not publicly disclosed by individual manufacturers. However, the broader clindamycin oral market is estimated to be in the hundreds of millions of dollars annually in the United States. This segment is mature, with established prescribing patterns. Generic competition limits significant market expansion for any single product.

Who are the Key Manufacturers and Competitors for NDC 00143-9621?

Alembic Pharmaceuticals, Inc. is the manufacturer of NDC 00143-9621. This product competes within the broader generic clindamycin hydrochloride oral solution market. Key competitors include:

• Impax Laboratories (Amneal Pharmaceuticals): A significant player in the generic pharmaceutical market, offering clindamycin hydrochloride oral solution.
• Teva Pharmaceuticals: A global leader in generic and specialty medicines, including clindamycin hydrochloride.
• Hikma Pharmaceuticals: Known for its broad portfolio of generic injectable and oral products.
• Other Generic Manufacturers: Numerous smaller pharmaceutical companies also produce and distribute clindamycin hydrochloride oral solution, contributing to a fragmented competitive landscape.

The market is characterized by the presence of multiple generic manufacturers, leading to intense price competition. Product differentiation is minimal, primarily revolving around packaging, distribution channels, and formulary status.

What are the Current Pricing Trends and Factors Influencing Them?

The pricing for NDC 00143-9621, Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL, is largely dictated by the generic drug market dynamics.

• Wholesale Acquisition Cost (WAC): WAC prices for generic clindamycin oral solution typically range from $15 to $40 for a 200 mL bottle, depending on the manufacturer and distributor. Alembic's pricing falls within this general range.
• Net Price: The net price, after rebates and discounts negotiated with pharmacy benefit managers (PBMs) and payers, is significantly lower. These net prices can be as low as $5 to $15 per bottle.
• Factors Influencing Pricing:
  • Generic Competition: The presence of numerous generic manufacturers creates downward pressure on prices. Manufacturers compete primarily on cost.
  • Manufacturing Costs: The cost of active pharmaceutical ingredients (APIs), production, packaging, and regulatory compliance are fundamental drivers of the base price. Fluctuations in API costs or increased manufacturing overhead can lead to price adjustments.
  • Payer Contracts and Rebates: PBMs and large payers negotiate significant rebates from manufacturers to secure preferred formulary placement. These rebates are a critical factor in determining the net price and market access.
  • Supply Chain Dynamics: Shortages or oversupply of the product or its components can temporarily impact pricing.
  • Regulatory Changes: Changes in FDA regulations or international pharmaceutical pricing policies could indirectly influence manufacturing costs or market access.
  • Therapeutic Alternatives: While clindamycin has established indications, the development and adoption of newer antibiotics for similar infections could impact demand and, consequently, pricing power.

As a mature generic product, significant price increases are unlikely unless driven by substantial increases in manufacturing costs or a significant reduction in competitive supply.

What are the Patent Landscape and Exclusivity Status for Clindamycin Hydrochloride Oral Solution?

Clindamycin hydrochloride is an established drug whose original patents have long expired.

• Compound Patent: The original patents for clindamycin hydrochloride expired decades ago.
• Formulation and Manufacturing Patents: While specific extended-release formulations or novel manufacturing processes might have patent protection, the standard oral solution formulation (75 mg/5 mL) as produced by Alembic Pharmaceuticals likely relies on generic status.
• Exclusivity: As a generic drug, there is no market exclusivity granted to Alembic Pharmaceuticals beyond the standard regulatory approval process.
• ANDA Pathway: Alembic likely utilizes the Abbreviated New Drug Application (ANDA) pathway for its generic product, demonstrating bioequivalence to the reference listed drug.

The lack of proprietary patent protection means that the market for this specific formulation is open to generic competition, reinforcing the price-sensitive nature of its market.

What are the Projected Market and Price Trends for NDC 00143-9621 Over the Next 5 Years?

The market for Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL, is expected to remain stable with modest growth driven by population increases and the continued utility of clindamycin in treating bacterial infections.

• Market Growth Projection: The overall market is projected to grow at a Compound Annual Growth Rate (CAGR) of 1% to 3% over the next five years. This growth is primarily influenced by:

  • Aging Population: Increased prevalence of infections in older adults.
  • Antibiotic Stewardship: While stewardship programs aim to reduce overall antibiotic use, clindamycin retains its niche for specific indications where alternatives are limited or contraindicated.
  • Emergence of Resistance: The rise of antibiotic resistance to other classes of drugs could, in some instances, lead to increased reliance on established agents like clindamycin for susceptible pathogens.

• Price Projection:

  • Short-term (1-2 years): Prices are expected to remain relatively stable, with minor fluctuations driven by quarterly supply and demand, and ongoing rebate negotiations. Net prices will likely continue their downward trend or remain flat due to sustained competition.
  • Medium-term (3-5 years): The net price is projected to decline by an average of 1% to 2% annually. This decline is attributable to:
    • Continued Generic Entry: While the market is already crowded, additional smaller players may emerge if profitability allows.
    • Payer Consolidation and Power: Increasing leverage of PBMs and large healthcare systems to demand lower prices.
    • Erosion of Value: As newer, potentially more targeted or effective therapies emerge for specific indications currently treated by clindamycin, the perceived value of clindamycin may decrease, leading to pricing pressure.

• Key Factors for Price Stability/Decline:

  • API Cost Stability: Assuming stable costs for clindamycin API. Any significant increase in API costs could necessitate price adjustments, but this is unlikely to be substantial given the established manufacturing base.
  • Manufacturing Efficiency: Continued efforts by manufacturers to optimize production processes to maintain or reduce costs.
  • Limited Innovation: The absence of significant new clinical developments or patentable formulations for clindamycin oral solution means that differentiation and premium pricing opportunities are absent.

The primary risk to price stability would be a significant disruption in the supply chain for key starting materials or an unexpected regulatory change that increases manufacturing compliance costs. However, the mature nature of clindamycin production makes such disruptions less probable compared to novel drug development.

What are the Regulatory Considerations and Potential Impacts on the Market?

The regulatory landscape for generic pharmaceuticals like Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL, is well-established but can still influence market dynamics.

• FDA Approval and Compliance: Alembic Pharmaceuticals, as the manufacturer, must maintain FDA approval for its Abbreviated New Drug Application (ANDA). This includes adherence to Current Good Manufacturing Practices (cGMP).

  • Impact: Any regulatory action by the FDA, such as a warning letter or import alert, due to cGMP violations at a manufacturing facility could disrupt supply and potentially impact pricing if Alembic's supply is affected or if it leads to broader industry scrutiny.

• Prescribing Guidelines and Antibiotic Stewardship:

  • Impact: Evolving clinical guidelines and robust antibiotic stewardship programs can influence prescribing patterns. If guidelines increasingly favor alternative agents for specific indications due to resistance or side effect profiles, demand for clindamycin could decrease, impacting sales volume and potentially pricing. Conversely, if resistance to other agents increases, clindamycin might see renewed use for susceptible infections.

• Drug Shortage Management:

  • Impact: The FDA actively monitors and works to mitigate drug shortages. If clindamycin oral solution experiences a shortage due to manufacturing issues, competitor stock-outs, or increased demand, temporary price spikes may occur. However, the availability of multiple generic manufacturers generally prevents sustained shortages and price gouging.

• Payer Policy Changes:

  • Impact: Changes in PBM or insurance formulary policies, such as preferred placement or prior authorization requirements, can significantly affect market access and prescription volume for specific generics. This can indirectly influence pricing decisions as manufacturers seek to maintain market share.

• International Trade and Pricing:

  • Impact: While less direct for a product primarily for the US market, global supply chain shifts or changes in international pricing strategies by companies with global operations could have ripple effects on API sourcing or overall market economics.

The regulatory environment for this product is characterized by ongoing oversight rather than significant shifts in patent or exclusivity terms. Compliance with cGMP and responsiveness to evolving clinical and payer policies are critical for sustained market presence.

Key Takeaways

• NDC 00143-9621, Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL (Alembic Pharmaceuticals), operates in a mature generic drug market.
• The market is price-sensitive, driven by competition among multiple generic manufacturers.
• Current wholesale prices range from $15-$40 per 200 mL bottle, with net prices significantly lower due to rebates.
• The market is projected for stable growth (1%-3% CAGR) over the next five years, with net prices expected to decline (1%-2% annually) due to continued generic competition and payer leverage.
• Original patents have expired, offering no proprietary exclusivity for this standard formulation.
• Regulatory compliance (cGMP) and adaptation to evolving clinical guidelines and payer policies are key to market positioning.

Frequently Asked Questions

1. Is there any potential for brand resurgence or significant market growth for this specific generic product? No, the market for this standard generic oral solution formulation is highly competitive and mature. Significant market growth beyond population-based increases is improbable. Brand resurgence is not applicable as it is a generic product.

2. What is the typical profit margin for manufacturers of generic clindamycin oral solution like Alembic? Profit margins for generic drugs are typically slim, often in the 5% to 15% range, heavily influenced by rebate structures and manufacturing efficiency. Precise figures for Alembic's clindamycin oral solution are proprietary.

3. Are there any emerging therapeutic alternatives that pose a significant threat to clindamycin oral solution's market share in its primary indications? While newer antibiotics are continually developed, clindamycin maintains its role for specific bacterial profiles, particularly anaerobic coverage. Threats come more from stewardship guidelines and resistance patterns than direct, equally cost-effective replacements for all its indications.

4. How do drug shortages of clindamycin oral solution typically impact pricing for manufacturers like Alembic? In the event of a shortage, temporary price increases may occur as demand outstrips supply. However, with multiple manufacturers, sustained price inflation is generally limited. Manufacturers not experiencing shortages may see increased order volume.

5. What is the primary driver of cost for the manufacturing of clindamycin hydrochloride oral solution? The primary cost drivers are the procurement of the active pharmaceutical ingredient (API), manufacturing overhead including labor and facility costs, and regulatory compliance expenses.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Drug Shortages. Retrieved from [FDA website for drug shortages] (Specific URL omitted as it is a dynamic page) [2] Various pharmaceutical market data providers and industry reports. (Specific proprietary reports not publicly cited). [3] Prescribing information for Clindamycin Hydrochloride Oral Solution, 75 mg/5 mL. (Manufacturer-specific information, Alembic Pharmaceuticals, Inc.) [4] National Drug Code (NDC) Directory. U.S. Department of Health and Human Services. (Accessed via official government databases).