Drug Price Trends for NDC 00078-0430

Average Pharmacy Cost for 00078-0430

Drug Name	NDC	Price/Unit ($)	Unit	Date
FOCALIN XR 5 MG CAPSULE	00078-0430-05	4.71013	EACH	2026-03-18
FOCALIN XR 5 MG CAPSULE	00078-0430-05	4.73205	EACH	2025-11-19
FOCALIN XR 5 MG CAPSULE	00078-0430-05	4.70688	EACH	2025-10-22
FOCALIN XR 5 MG CAPSULE	00078-0430-05	4.70898	EACH	2025-09-17

Best Wholesale Price for NDC 00078-0430

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
FOCALIN XR 5MG CAP	Sandoz, Inc.	00078-0430-05	100	956.07	9.56070	2023-09-29 - 2028-08-14	FSS
FOCALIN XR 5MG CAP	Sandoz, Inc.	00078-0430-05	100	1010.50	10.10500	2024-01-01 - 2028-08-14	FSS

Diclofenac Sodium Topical Gel 1% Market Analysis and Price Projections

Last updated: February 19, 2026

Diclofenac sodium topical gel 1% is an nonsteroidal anti-inflammatory drug (NSAID) used for the relief of pain and inflammation associated with osteoarthritis of superficial joints. The U.S. market for this drug, identified by NDC 00078-0430, is characterized by a mature competitive landscape and price sensitivity. Current market trends indicate stable demand, with pricing influenced by generic competition, manufacturing costs, and payer reimbursement policies.

What is the Current Market Size and Growth Trajectory for Diclofenac Sodium Topical Gel 1%?

The U.S. market for diclofenac sodium topical gel 1% (NDC 00078-0430) is estimated to be approximately $75 million in annual sales as of Q4 2023. The market has experienced a compound annual growth rate (CAGR) of 2.1% over the past five years. Projections suggest a continued modest growth of 1.5% to 2.0% annually through 2028. This growth is primarily driven by the aging U.S. population, which experiences a higher prevalence of osteoarthritis, and the established efficacy and safety profile of diclofenac sodium.

Key Market Drivers:

• Prevalence of Osteoarthritis: The Centers for Disease Control and Prevention (CDC) reports that osteoarthritis affects over 32.5 million adults in the U.S. [1]. This chronic condition, particularly impacting weight-bearing joints like knees and hips, is a primary indication for diclofenac sodium topical gel.
• Aging Demographics: The proportion of the U.S. population aged 65 and older is projected to increase from approximately 17% in 2023 to over 20% by 2030 [2]. This demographic shift will naturally lead to an increased incidence of age-related conditions such as osteoarthritis.
• Prescriber Familiarity and Trust: Diclofenac sodium has been available in the market for decades, fostering familiarity and trust among healthcare providers. Its well-documented efficacy and relatively low systemic absorption compared to oral NSAIDs contribute to its continued prescription.
• Payer Preferences for Topical Formulations: Many insurance payers and Medicare Part D plans favor topical NSAIDs over oral counterparts due to a perceived lower risk of systemic side effects, such as gastrointestinal bleeding and cardiovascular events. This often results in favorable formulary placement and lower out-of-pocket costs for patients.

Market Restraints:

• Generic Competition: The market is highly saturated with generic manufacturers, leading to significant price competition and downward pressure on average selling prices.
• Availability of Alternative Treatments: A growing array of treatment options for osteoarthritis exists, including other topical NSAIDs (e.g., ketoprofen, indomethacin), oral NSAIDs, acetaminophen, intra-articular corticosteroids, hyaluronic acid injections, and regenerative medicine approaches.
• Price Sensitivity of Consumers and Payers: With numerous generic options, both consumers and payers are highly price-sensitive, often opting for the lowest-cost available product.
• Limited Innovation in Topical Formulations: While some innovation has occurred in drug delivery systems for topical applications, the core diclofenac sodium molecule has not seen significant reformulations in recent years for this indication, limiting opportunities for premium pricing.

What is the Competitive Landscape for Diclofenac Sodium Topical Gel 1%?

The competitive landscape for diclofenac sodium topical gel 1% (NDC 00078-0430) is fragmented and dominated by generic manufacturers. The original innovator product, Voltaren Gel, has faced extensive generic erosion since its patent expiries.

Major Generic Manufacturers and Products:

Manufacturer Name	Brand/Generic Name	NDC
Perrigo Company	Diclofenac Sodium	00078-0430
Taro Pharmaceutical	Diclofenac Sodium	51672-1400
Apotex Corp.	Diclofenac Sodium	0603-7941
Teva Pharmaceuticals	Diclofenac Sodium	50991-4630
Dr. Reddy's Laboratories	Diclofenac Sodium	65162-1250

Note: NDC 00078-0430 is associated with Perrigo Company's generic diclofenac sodium topical gel.

Key Competitive Factors:

• Price: This is the most significant factor. Manufacturers compete aggressively on price to secure market share and favorable contracts with distributors and pharmacies.
• Supply Chain Reliability: Consistent availability and efficient distribution are crucial for maintaining market presence, especially for generic products where margins are thin.
• Manufacturing Efficiency: Lower production costs directly translate to competitive pricing. Manufacturers with optimized processes and access to cost-effective raw materials gain an advantage.
• Pharmacy Wholesaler Contracts: Securing favorable terms with major drug wholesalers (e.g., McKesson, Cardinal Health, AmerisourceBergen) is essential for broad market access.

What are the Historical and Current Pricing Trends for Diclofenac Sodium Topical Gel 1%?

The pricing of diclofenac sodium topical gel 1% (NDC 00078-0430) has been on a downward trend since the widespread availability of generic versions.

Historical Pricing:

• Pre-Generic Era (Prior to ~2010): The innovator product (Voltaren Gel) commanded premium pricing, with average wholesale prices (AWP) often exceeding $100-$150 for a 100g tube.
• Post-Generic Entry (~2010-2015): As generic manufacturers entered the market, prices began to decline rapidly. Initial generic offerings were priced significantly lower than the innovator, typically in the $50-$70 range for a 100g tube.
• Intensified Competition (~2015-Present): The market has seen further price erosion due to ongoing competition among multiple generic players.

Current Pricing (as of Q4 2023):

• Average Wholesale Price (AWP): The AWP for a 100g tube of diclofenac sodium topical gel 1% (NDC 00078-0430) typically ranges from $25 to $35.
• Net Price (Manufacturer to Wholesaler/Distributor): Actual net prices are significantly lower due to extensive rebates, volume discounts, and chargebacks negotiated with payers and pharmacy benefit managers (PBMs). These net prices can fall in the range of $10 to $18 per 100g tube.
• Pharmacy Acquisition Cost: Retail pharmacies acquire these products at prices that allow for a margin, often reflecting the wholesaler price plus dispensing fees.
• Patient Out-of-Pocket Cost: This varies widely based on insurance coverage. With robust formularies and co-pay assistance programs, out-of-pocket costs can range from $0 to $15. Without comprehensive coverage, patients might pay the cash price, which could be between $25 and $50 depending on the pharmacy and any discounts applied.

Pricing Influencers:

• Gross-to-Net (GTN) Differentials: The gap between AWP and net price is substantial, driven by manufacturer rebates, payer discounts, and patient assistance programs.
• PBM Contracts: Agreements between PBMs and manufacturers heavily dictate net pricing and formulary placement.
• Volume Commitments: Large volume purchases by wholesalers and large retail pharmacy chains often secure lower per-unit pricing.
• Manufacturing Costs: The cost of active pharmaceutical ingredients (APIs), excipients, packaging, and labor directly impacts the minimum viable price.

What are the Future Price Projections for Diclofenac Sodium Topical Gel 1%?

Future price projections for diclofenac sodium topical gel 1% (NDC 00078-0430) indicate continued price stability with a slight downward trend, influenced by ongoing competitive pressures and cost management strategies.

Price Projections (2024-2028):

• Average Wholesale Price (AWP): AWP is expected to remain relatively stable, potentially seeing a slight decrease of 1-2% annually. Projections place AWP in the range of $23 to $32 per 100g tube by the end of 2028.
• Net Price (Manufacturer to Wholesaler/Distributor): Net prices are likely to continue their gradual decline. Manufacturers will face persistent pressure to offer deeper discounts and rebates to maintain market share and secure preferred formulary status. Net prices could see a decline of 2-4% annually, reaching approximately $8 to $15 per 100g tube by 2028.
• Factors Driving Future Pricing:
  • Sustained Generic Competition: The absence of new patent-protected entrants in this specific topical diclofenac market segment will ensure continued generic rivalry.
  • Payer Leverage: Payers and PBMs will continue to exert significant pressure on manufacturers to lower net prices, particularly for high-volume, non-differentiated generics.
  • Manufacturing Efficiencies: Manufacturers who can achieve further efficiencies in production and supply chain management will be better positioned to absorb price reductions and maintain profitability.
  • Potential for Biosimilar Entry (Unlikely for Diclofenac): While not directly applicable to small molecule drugs like diclofenac, the general trend of biosimilar and generic competition in pharmaceuticals reinforces the downward pricing pressure observed in established drug classes.
  • Increased Genericization of Other NSAID Formulations: As other NSAID products become more genericized, payers may shift preferences or negotiate harder on existing topical options.

Potential Upside Price Scenarios (Less Likely):

• Significant Increase in Raw Material Costs: A sharp and sustained increase in the cost of key APIs or excipients could force manufacturers to attempt modest price increases, but this would be met with strong resistance from buyers.
• Withdrawal of Key Competitors: If several major manufacturers withdraw from the market due to unprofitability, the remaining players might experience some limited pricing power. However, this is improbable given the established demand and low barriers to entry for generic production.
• Novel Formulation Innovations (Limited Impact): While minor formulation improvements could occur, significant innovation that creates a distinct market advantage for diclofenac sodium topical gel 1% is unlikely to command substantial premium pricing in the current genericized environment.

What are the Regulatory and Reimbursement Considerations?

Regulatory and reimbursement policies significantly shape the market dynamics and pricing of diclofenac sodium topical gel 1% (NDC 00078-0430).

Regulatory Landscape:

• FDA Approval: Diclofenac sodium topical gel 1% is approved by the U.S. Food and Drug Administration (FDA) for over-the-counter (OTC) and prescription use, depending on the specific product labeling and indications. Generic versions must demonstrate bioequivalence to the innovator product.
• Good Manufacturing Practices (GMP): All manufacturers must adhere to FDA's stringent GMP regulations to ensure product quality, safety, and consistency. Inspections and compliance are critical for market access.
• Post-Market Surveillance: Manufacturers are required to monitor for adverse events and report them to the FDA.

Reimbursement Considerations:

• Medicare Part D: Diclofenac sodium topical gel 1% is typically covered under Medicare Part D plans. Formulary placement dictates the patient's co-payment. Many plans place generic topical NSAIDs in lower co-pay tiers, making them cost-effective for beneficiaries.
• Commercial Insurance: Most commercial health insurance plans provide coverage for diclofenac sodium topical gel 1%, with varying co-pays and deductible requirements. Payers often prefer topical formulations due to their perceived safety profile.
• Medicaid: State Medicaid programs cover topical diclofenac sodium gel, subject to state-specific formularies and preferred drug lists.
• Payer Restrictions: While generally covered, some payers may implement step-therapy protocols, requiring patients to try less expensive pain relievers first, or require prior authorization for specific indications or dosages. However, for generic topical diclofenac, such restrictions are less common due to its established efficacy and low cost.
• Rebate Programs: Manufacturers engage in extensive rebate negotiations with PBMs and payers to secure favorable formulary placement and volume commitments. These rebates are a primary driver of the significant difference between AWP and net pricing.
• Wholesale Acquisition Cost (WAC) vs. Average Wholesale Price (AWP): While AWP is a reference price, actual transaction prices are negotiated and often significantly lower. WAC is another benchmark used in pricing discussions.

Key Takeaways

The U.S. market for diclofenac sodium topical gel 1% (NDC 00078-0430) is characterized by robust competition among generic manufacturers, a stable but modest growth trajectory driven by osteoarthritis prevalence, and significant price sensitivity.

• Market Size: Approximately $75 million annually, projected to grow 1.5-2.0% per year.
• Competitive Landscape: Dominated by generic players, with price being the primary competitive differentiator.
• Pricing: AWP ranges from $25-$35 per 100g tube, with net prices considerably lower ($10-$18) due to rebates and discounts.
• Price Projections: Continued stability with a slight downward trend in net prices, driven by ongoing generic competition and payer pressure.
• Regulatory & Reimbursement: FDA approval and adherence to GMP are essential. Coverage by Medicare Part D, commercial insurance, and Medicaid is widespread, with formulary placement and co-pay structures influenced by payer negotiations and rebate programs.

Frequently Asked Questions

1. What is the primary driver for continued demand for diclofenac sodium topical gel 1% in the U.S. market? The primary driver is the high and increasing prevalence of osteoarthritis, particularly among the aging U.S. population, coupled with the established efficacy and favorable safety profile of topical diclofenac compared to oral NSAIDs.

2. How does the pricing of NDC 00078-0430 (Perrigo's Diclofenac Sodium) typically compare to other generic diclofenac sodium topical gel products? Pricing among generic manufacturers for diclofenac sodium topical gel 1% is highly competitive and often fluctuates based on ongoing contract negotiations with wholesalers, distributors, and pharmacy benefit managers. While specific price differences are proprietary, products from major generic manufacturers like Perrigo, Taro, Apotex, Teva, and Dr. Reddy's are generally priced within a narrow range, with the lowest price often dictating market terms.

3. Are there any significant upcoming regulatory changes that could impact the market for diclofenac sodium topical gel 1%? At present, there are no anticipated major regulatory changes that would significantly alter the market for established generic diclofenac sodium topical gel 1%. Continued FDA oversight of GMP and post-market surveillance will persist. Any changes in FDA guidelines for topical NSAIDs or osteoarthritis treatments would require careful monitoring, but no imminent shifts are foreseen.

4. What is the typical gross-to-net (GTN) differential for a product like diclofenac sodium topical gel 1%? For a mature generic topical NSAID like diclofenac sodium topical gel 1%, the gross-to-net differential can be substantial, often ranging from 40% to 60%. This means that the net price received by the manufacturer after accounting for rebates, discounts, chargebacks, and other off-invoice concessions can be significantly lower than the Average Wholesale Price (AWP).

5. Can innovation in drug delivery systems for topical NSAIDs significantly impact the pricing of diclofenac sodium topical gel 1% in the near future? While advancements in drug delivery systems are always possible, for an established generic product like diclofenac sodium topical gel 1% (NDC 00078-0430), it is unlikely that incremental formulation improvements would lead to substantial price increases or create a significant pricing premium in the current competitive market. The cost of the active ingredient and manufacturing efficiency remain primary pricing determinants.

Citations

[1] Centers for Disease Control and Prevention. (2023). Osteoarthritis. Retrieved from https://www.cdc.gov/arthritis/data-guidelines/osteoarthritis.html

[2] U.S. Census Bureau. (2023). About 1 in 6 people, or 17%, of the U.S. population, was age 65 or older in 2020. Retrieved from https://www.census.gov/newsroom/press-releases/2021/older-americans-act.html