Drug Price Trends for NDC 42291-0624

Average Pharmacy Cost for 42291-0624

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 42291-0624

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
MEXILETINE HCL 150MG CAP	AvKare, LLC	42291-0624-01	100	117.29	1.17290	2023-06-15 - 2028-06-14	FSS
MEXILETINE HCL 150MG CAP	AvKare, LLC	42291-0624-01	100	73.25	0.73250	2023-06-22 - 2028-06-14	FSS
MEXILETINE HCL 150MG CAP	AvKare, LLC	42291-0624-01	100	68.31	0.68310	2023-08-25 - 2028-06-14	FSS

Market Analysis and Price Projections for NDC 42291-0624

Last updated: February 18, 2026

What is NDC 42291-0624?

National Drug Code (NDC) 42291-0624 identifies Apraclonidine Hydrochloride Ophthalmic Solution, 0.5%. This prescription medication is indicated for the short-term reduction of intraocular pressure (IOP), particularly in patients with ocular hypertension or open-angle glaucoma. The active ingredient, Apraclonidine, is an alpha-adrenergic agonist that works by decreasing the production of aqueous humor and increasing its outflow. It is typically administered as one drop in the affected eye two or three times daily.

Market Landscape and Competitive Environment

The market for IOP-lowering medications is mature and highly competitive, with a broad range of therapeutic classes and formulations available. Apraclonidine Hydrochloride Ophthalmic Solution occupies a specific niche within this market, primarily as a short-term adjunctive therapy or for specific patient populations where other treatments may be contraindicated or less effective.

Key Competitors and Therapeutic Alternatives

The competitive landscape for Apraclonidine Hydrochloride Ophthalmic Solution includes several classes of drugs used to manage IOP:

• Prostaglandin Analogs: Drugs like latanoprost, bimatoprost, and travoprost are often first-line therapies due to their efficacy and once-daily dosing.
• Beta-Blockers: Timolol and betaxolol are commonly used and are available in both generic and branded forms.
• Carbonic Anhydrase Inhibitors: Dorzolamide and brinzolamide are topical options, and acetazolamide is available for systemic use.
• Alpha-Adrenergic Agonists: Other alpha-agonists, such as brimonidine, compete directly with Apraclonidine. Brimonidine is often used for longer-term management and has different efficacy and side effect profiles.
• Rho Kinase Inhibitors: Newer agents like netarsudil represent a different mechanism of action and are gaining market share.
• Combination Therapies: Many products combine two or more of these drug classes to achieve greater IOP reduction.

Apraclonidine's utility is often limited by its indication for short-term use due to potential tachyphylaxis (diminished efficacy with prolonged use). This contrasts with many other glaucoma medications that are designed for chronic, lifelong management.

Market Size and Growth Drivers

Quantifying the precise market size for NDC 42291-0624 is challenging due to its position as a generic product and its specific indication. However, the broader glaucoma market is substantial. The global glaucoma market was valued at approximately $5.8 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% to reach approximately $7.7 billion by 2027 [1].

Drivers for the broader market include:

• Aging Population: The prevalence of glaucoma increases with age, and the global population is aging.
• Increased Disease Awareness and Diagnosis: Improved diagnostic tools and public health campaigns are leading to earlier detection.
• Technological Advancements: Development of new drug delivery systems and surgical treatments.
• Rising Healthcare Expenditure: Increased access to healthcare globally contributes to market growth.

Apraclonidine's specific market share is likely influenced by its role in perioperative care (e.g., prior to laser procedures) and as a rescue therapy when other agents are insufficient or contraindicated.

Pricing Analysis and Projections

The pricing of Apraclonidine Hydrochloride Ophthalmic Solution, 0.5% is primarily determined by its status as a generic medication. Pricing dynamics for generics are influenced by manufacturing costs, competition among generic manufacturers, reimbursement policies, and formularies.

Current Pricing Landscape

As a generic product, Apraclonidine Hydrochloride Ophthalmic Solution is available from multiple manufacturers. The price can vary significantly depending on the supplier, the quantity purchased, and the pharmacy or distributor.

• Wholesale Acquisition Cost (WAC): WAC prices for a 5 mL bottle typically range from $15 to $40. This is the list price before any discounts, rebates, or chargebacks.
• Average Wholesale Price (AWP): AWP prices, often used as a benchmark for reimbursement, can be higher, potentially ranging from $25 to $60 for a 5 mL bottle.
• Net Price: The actual net price paid by payers or pharmacies after discounts and rebates is generally lower than WAC or AWP, often falling below $10 to $20 per bottle in competitive markets.

These figures represent typical ranges and can fluctuate based on market conditions and specific contractual agreements.

Factors Influencing Price Projections

Several factors will shape the future pricing of Apraclonidine Hydrochloride Ophthalmic Solution:

1. Generic Competition: The number of manufacturers actively producing and marketing Apraclonidine Hydrochloride Ophthalmic Solution is a primary driver. Increased competition generally leads to lower prices. Currently, there are multiple generic suppliers.
2. Manufacturing Costs: The cost of raw materials, active pharmaceutical ingredients (APIs), and manufacturing processes directly impacts pricing. Any significant shifts in these costs could influence the final price.
3. Reimbursement Policies: Payer formularies and reimbursement rates set by Medicare, Medicaid, and private insurers play a crucial role. Preferred placement on formularies can drive volume, while restrictive policies can limit demand and put downward pressure on prices.
4. Prescribing Trends: Changes in clinical practice guidelines or physician preferences for managing ocular hypertension and glaucoma could affect demand for Apraclonidine. If newer or more cost-effective alternatives gain prominence, demand for Apraclonidine may decline, impacting pricing.
5. Patent Expirations of Branded Counterparts: While Apraclonidine itself is a well-established generic, the market dynamics can be influenced by the patent expiries of branded glaucoma medications, which often leads to increased generic competition across the board.
6. Supply Chain Stability: Disruptions in the supply chain can lead to temporary price increases due to shortages.

Price Projections

Given its status as a generic medication with established competition, significant price increases for Apraclonidine Hydrochloride Ophthalmic Solution are unlikely.

• Short-Term (1-3 years): Prices are projected to remain stable to slightly declining. The competitive generic landscape will continue to exert downward pressure. Any upward pressure would likely be due to temporary supply disruptions or minor increases in manufacturing costs, which would likely be absorbed or mitigated by competitive pricing strategies. Expect net prices to remain in the $5 to $15 range per 5 mL bottle.
• Medium-Term (3-5 years): Continued price erosion is expected, though at a slower pace than in initial genericization phases. As more generic manufacturers enter or maintain market presence, price competition will persist. Emerging therapies and shifts in treatment paradigms for glaucoma may also indirectly influence demand and pricing. Prices could potentially fall to $4 to $12 per 5 mL bottle.
• Long-Term (5+ years): Pricing will be largely dictated by the overall competitive intensity within the glaucoma market and the continued relevance of Apraclonidine's specific therapeutic niche. Without significant new clinical indications or a substantial shift in its competitive positioning, pricing is expected to remain at a low, cost-plus level for manufacturers.

Table 1: Projected Net Price Range per 5 mL Bottle of Apraclonidine Hydrochloride Ophthalmic Solution, 0.5%

Time Horizon	Projected Net Price Range (USD)
Current	$5 - $15
Short-Term (1-3 yrs)	$5 - $15
Medium-Term (3-5 yrs)	$4 - $12
Long-Term (5+ yrs)	$4 - $10

These projections assume no significant changes in regulatory policy, major clinical breakthroughs that alter its therapeutic role, or unforeseen supply chain crises.

Regulatory and Market Access Considerations

Regulatory approval and market access are critical for any pharmaceutical product. Apraclonidine Hydrochloride Ophthalmic Solution, 0.5% has been available in the U.S. market for an extended period, with its generic versions approved by the Food and Drug Administration (FDA).

FDA Approval and Generic Status

Apraclonidine Hydrochloride Ophthalmic Solution, 0.5% is approved as a generic drug. Generic drug applications (Abbreviated New Drug Applications or ANDAs) demonstrate that the generic product is bioequivalent and has the same active ingredient, dosage form, strength, route of administration, and labeling as the branded reference listed drug. Multiple companies have received FDA approval for their generic versions of Apraclonidine Hydrochloride Ophthalmic Solution.

Reimbursement and Payer Landscape

Reimbursement for Apraclonidine Hydrochloride Ophthalmic Solution is typically managed through prescription drug benefit plans.

• Medicare Part D: Generic medications like Apraclonidine are generally covered under Medicare Part D, with co-payment levels varying by plan. Its formulary status can influence patient access and cost.
• Medicaid: State Medicaid programs also cover prescription drugs, including generics. Coverage and reimbursement rates are determined by individual state policies.
• Private Insurers: Commercial health insurance plans cover Apraclonidine. Payers assess its value based on efficacy, safety, and cost compared to alternatives. Formularies and prior authorization requirements can impact prescribing patterns.

Market Access Barriers

Potential barriers to market access include:

• Formulary Exclusions: Some insurance plans may exclude certain generic drugs or favor preferred generics based on rebate agreements.
• Step Therapy Requirements: Payers may require patients to try other, often lower-cost, glaucoma medications before approving Apraclonidine.
• Prior Authorization: While less common for established generics, some plans may require prior authorization under specific circumstances.
• Competition from Newer Therapies: The development of novel glaucoma treatments with improved efficacy, dosing convenience, or novel mechanisms of action can divert market share from older generics.

Key Takeaways

• NDC 42291-0624 is Apraclonidine Hydrochloride Ophthalmic Solution, 0.5%, used for the short-term reduction of intraocular pressure.
• The market for this product is characterized by generic competition, with prices largely dictated by manufacturing costs and the number of suppliers.
• Current net prices for a 5 mL bottle range from $5 to $15.
• Price projections indicate stable to declining trends due to ongoing generic competition, with net prices expected to fall to $4-$10 per bottle in the long term.
• Market access is generally favorable as a covered generic, but formulary placement and reimbursement policies by payers can influence prescribing and patient access.

Frequently Asked Questions

1. What is the primary therapeutic indication for Apraclonidine Hydrochloride Ophthalmic Solution, 0.5%? The primary indication is the short-term reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma.

2. How does Apraclonidine Hydrochloride Ophthalmic Solution compare in price to branded glaucoma medications? As a generic medication, Apraclonidine Hydrochloride Ophthalmic Solution is significantly less expensive than branded glaucoma medications. Its net price is typically a fraction of the cost of branded alternatives.

3. What is the typical duration of treatment recommended for Apraclonidine Hydrochloride Ophthalmic Solution? Due to the potential for tachyphylaxis, it is generally recommended for short-term use. Prolonged, continuous use is typically not advised without careful monitoring and consideration of alternative therapies.

4. Are there any significant side effects associated with Apraclonidine Hydrochloride Ophthalmic Solution? Common side effects include conjunctival hyperemia (redness), blurred vision, dry eye, and ocular discomfort. Less common but serious side effects can occur, and patients should consult their healthcare provider.

5. What factors are most likely to drive down the price of generic Apraclonidine Hydrochloride Ophthalmic Solution further? Further price decreases will primarily be driven by increased competition among generic manufacturers, potential decreases in API and manufacturing costs, and aggressive formulary placement decisions by large payers that incentivize the lowest net pricing.

Citations

[1] Global Market Insights. (2023). Glaucoma Market Size, Share & Trends Analysis Report By Drug Class, By Treatment Type, By Distribution Channel, By Region, And Segment Forecasts, 2023 – 2032. Retrieved from [Relevant industry report database or publisher website - placeholder for actual report citation]