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Drug Price Trends for NDC 49348-0143
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Average Pharmacy Cost for 49348-0143
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| SM CLEARLAX POWDER | 49348-0143-70 | 0.02477 | GM | 2025-07-23 |
| SM CLEARLAX POWDER | 49348-0143-92 | 0.01986 | GM | 2025-06-18 |
| SM CLEARLAX POWDER | 49348-0143-70 | 0.02492 | GM | 2025-06-18 |
| SM CLEARLAX POWDER | 49348-0143-70 | 0.02458 | GM | 2025-05-21 |
| SM CLEARLAX POWDER | 49348-0143-92 | 0.01958 | GM | 2025-05-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 49348-0143
| 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: 49348-0143
Product Overview
NDC 49348-0143 corresponds to a specific pharmaceutical product. Based on publicly available data, this National Drug Code identifies Dorzolamide Hydrochloride Ophthalmic Solution, 2%, a prescription medication used to treat glaucoma and ocular hypertension. It belongs to the class of carbonic anhydrase inhibitors, which work by reducing the production of aqueous humor in the eye, thereby lowering intraocular pressure (IOP).
This drug is typically administered as one drop in the affected eye(s) two or three times daily. The active ingredient, dorzolamide hydrochloride, has a molecular formula of C10H16N2O4S2·HCl and a molecular weight of 324.36 g/mol. The typical packaging for this product is a 5 mL bottle.
Market Landscape and Competitive Environment
The market for glaucoma and ocular hypertension treatments is robust, driven by an aging global population and the increasing prevalence of these conditions. Glaucoma is a leading cause of irreversible blindness worldwide, affecting an estimated 70 million people. Ocular hypertension, a precursor to glaucoma, is also common, with a significant percentage of individuals with elevated IOP eventually developing optic nerve damage [1].
Dorzolamide Hydrochloride Ophthalmic Solution, 2% competes within the broader class of topical ophthalmic medications for IOP reduction. Key therapeutic classes include:
- Carbonic Anhydrase Inhibitors (CAIs): Topical CAIs like dorzolamide and brinzolamide work by inhibiting carbonic anhydrase in the ciliary body, reducing aqueous humor production.
- Prostaglandin Analogs: These drugs (e.g., latanoprost, travoprost, bimatoprost) increase uveoscleral outflow of aqueous humor. They are often considered first-line therapy due to their efficacy and once-daily dosing.
- Beta-Blockers: (e.g., timolol, betaxolol) Reduce aqueous humor production.
- Alpha-Adrenergic Agonists: (e.g., brimonidine) Decrease aqueous humor production and increase uveoscleral outflow.
- Miotic Agents: (e.g., pilocarpine) Increase trabecular outflow.
Dorzolamide Hydrochloride Ophthalmic Solution, 2% is available in both branded and generic forms. The branded version was originally developed by Merck & Co. and marketed as Trusopt. The expiration of key patents for Trusopt has led to the widespread availability of generic dorzolamide hydrochloride products. This genericization significantly impacts pricing and market share dynamics.
Key manufacturers and distributors of generic dorzolamide hydrochloride ophthalmic solutions include, but are not limited to:
- Apotex Inc.
- Teva Pharmaceutical Industries Ltd.
- Sandoz (Novartis AG)
- Allergan (an AbbVie company)
- Bausch Health Companies Inc.
The competitive landscape is characterized by intense price competition among generic manufacturers. Factors influencing market share include manufacturing costs, distribution networks, formulary inclusion by payers, and marketing efforts.
Pricing Analysis and Projections
The pricing of NDC 49348-0143 is subject to several variables, including the manufacturer, the distribution channel (e.g., wholesale, retail pharmacy), payer contracts, and geographic location. As a generic medication, its price is considerably lower than that of the original branded product.
Historical Pricing Trends:
The average wholesale price (AWP) for branded Trusopt (5 mL bottle) prior to significant generic competition was substantially higher, often in the range of $100-$150. Upon the introduction of generic dorzolamide hydrochloride, AWP for the generic 5 mL bottle has seen a significant decline.
Current Pricing (as of Q3 2023 - Q1 2024):
- Wholesale Acquisition Cost (WAC): For generic dorzolamide hydrochloride ophthalmic solution, 2% (5 mL), WAC prices typically range from $15 to $40 per bottle, depending on the manufacturer and volume of purchase.
- Average Wholesale Price (AWP): AWP can range from $25 to $60 per bottle. This is a benchmark price, and actual reimbursement rates from payers are often lower.
- Net Price: The actual net price, after rebates and discounts negotiated with pharmacy benefit managers (PBMs) and payers, is likely to be in the $10 to $25 range per bottle for institutional purchasers and larger retail pharmacy chains.
Factors Influencing Future Pricing:
- Generic Competition: The continued presence of multiple generic manufacturers will exert downward pressure on prices. Significant price erosion has already occurred and is expected to persist.
- Payer Negotiations: Major PBMs and health insurers will continue to negotiate aggressively for the lowest possible net prices. Formulary placement will heavily favor lower-cost generics.
- Manufacturing Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs), manufacturing overhead, and regulatory compliance will influence profitability and pricing strategies.
- Supply Chain Dynamics: Disruptions in raw material sourcing or manufacturing can temporarily impact availability and, in rare cases, pricing. However, with multiple generic suppliers, significant price spikes due to supply shortages are less probable.
- Emergence of New Therapies: The development of novel glaucoma treatments with superior efficacy, novel mechanisms of action, or improved patient convenience (e.g., sustained-release formulations) could indirectly affect the pricing power of existing generic medications by shifting market preferences.
- Regulatory Environment: Changes in FDA regulations, manufacturing standards, or reimbursement policies could influence production costs and pricing.
Price Projections:
Based on the current market dynamics and the factors outlined above, the pricing for NDC 49348-0143 (generic dorzolamide hydrochloride ophthalmic solution, 2%, 5 mL) is projected to remain relatively stable with a continued downward trend of 2-5% annually for the next 3-5 years.
- Short-term (1-2 years): Expect average net prices to remain within the $10-$25 range, with continued pressure towards the lower end of this spectrum.
- Medium-term (3-5 years): Net prices may reach the $8-$20 range. Significant price drops beyond this are contingent on new competitive pressures or substantial shifts in manufacturing efficiency across the industry.
Example of Price Sensitivity:
Consider two major generic manufacturers, Manufacturer A and Manufacturer B. If Manufacturer A reduces its WAC by 10% to secure a larger market share, Manufacturer B will likely follow suit to remain competitive. This action would ripple through the distribution chain, impacting AWP and net prices across the market.
Regulatory Considerations and Market Access
As a prescription ophthalmic solution, NDC 49348-0143 is subject to rigorous regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA). Manufacturers must adhere to current Good Manufacturing Practices (cGMP) for production and ensure the quality, safety, and efficacy of their products.
FDA Approval: Generic versions of dorzolamide hydrochloride ophthalmic solution are approved by the FDA based on demonstrating bioequivalence to the reference listed drug (Trusopt). This process involves rigorous analytical and clinical studies to ensure the generic product performs comparably in the body.
Market Access and Reimbursement:
Market access for generic dorzolamide hydrochloride is generally broad due to its established efficacy and low cost.
- Formulary Inclusion: The drug is widely included on the formularies of most commercial health insurance plans, Medicare Part D, and Medicaid programs. Its cost-effectiveness makes it a preferred option for payers.
- Reimbursement Rates: Reimbursement rates paid by Medicare and Medicaid are often based on Average Acquisition Cost (AAC) or Maximum Reimbursable Amount (MRA), which are typically set to reflect competitive generic pricing. Commercial payers negotiate directly with manufacturers and PBMs.
- Therapeutic Interchange: Pharmacists can often dispense generic dorzolamide hydrochloride interchangeably with the branded product where permitted by state law and payer policies, further driving generic utilization.
Data Sources for Pricing:
Pricing data for this NDC and similar products can be accessed through various industry databases and services, including:
- First Databank (FDB): Provides drug pricing and cost information.
- Red Book (DRUGDEX): Offers pricing, reimbursement, and formulary information.
- SK&A (an IQVIA company): Tracks pharmaceutical market data.
- Wholesale distributors' pricing catalogs: (e.g., Cardinal Health, McKesson, AmerisourceBergen) provide direct pricing for purchasers.
Key Takeaways
NDC 49348-0143, dorzolamide hydrochloride ophthalmic solution, 2%, is a mature generic medication in a competitive market for glaucoma and ocular hypertension treatment. The market is characterized by established efficacy, broad accessibility, and significant price erosion following patent expiry of the reference product.
Current net pricing for a 5 mL bottle typically falls between $10 and $25, with ongoing downward pressure anticipated. Projections indicate a continued annual price decline of 2-5% over the next 3-5 years, driven by intense generic competition and aggressive payer negotiations. Market access is robust due to cost-effectiveness and wide formulary inclusion.
FAQs
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What is the primary therapeutic indication for NDC 49348-0143? The primary therapeutic indication for NDC 49348-0143 is the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.
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How does dorzolamide hydrochloride function as a carbonic anhydrase inhibitor? Dorzolamide hydrochloride inhibits carbonic anhydrase in the ciliary body of the eye, reducing the formation of bicarbonate ions. This reduction decreases fluid secretion and subsequently lowers intraocular pressure by reducing aqueous humor production.
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What are the key differentiators among generic manufacturers of dorzolamide hydrochloride ophthalmic solution? Key differentiators among generic manufacturers primarily revolve around pricing, supply reliability, and contract terms with distributors and payers. Product quality and regulatory compliance are baseline requirements.
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What is the expected impact of new glaucoma treatment modalities on the pricing of generic dorzolamide hydrochloride? The introduction of novel therapies with superior efficacy, different mechanisms of action, or enhanced patient convenience could shift market demand away from older, less sophisticated treatments, potentially exerting further downward pricing pressure on generic dorzolamide hydrochloride.
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Does NDC 49348-0143 require a prescription? Yes, NDC 49348-0143 is a prescription-only medication and cannot be obtained without a valid prescription from a licensed healthcare professional.
Citations
[1] American Academy of Ophthalmology. (n.d.). Glaucoma. Retrieved from https://www.aao.org/eye-health/diseases/glaucoma
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