Drug Price Trends for NDC 50474-0595

Average Pharmacy Cost for 50474-0595

Drug Name	NDC	Price/Unit ($)	Unit	Date
KEPPRA 500 MG TABLET	50474-0595-40	9.91977	EACH	2026-01-01
KEPPRA 500 MG TABLET	50474-0595-40	9.66839	EACH	2025-12-17
KEPPRA 500 MG TABLET	50474-0595-40	9.66821	EACH	2025-11-19
KEPPRA 500 MG TABLET	50474-0595-40	9.67175	EACH	2025-10-22
KEPPRA 500 MG TABLET	50474-0595-40	9.66877	EACH	2025-09-17
KEPPRA 500 MG TABLET	50474-0595-40	9.67258	EACH	2025-08-20

Best Wholesale Price for NDC 50474-0595

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

Patent Landscape and Market Projections for NDC 50474-0595

Last updated: February 19, 2026

This analysis examines the patent status and projects market pricing for the pharmaceutical product identified by National Drug Code (NDC) 50474-0595. The product, known generically as apremilast, is indicated for the treatment of moderate to severe plaque psoriasis and psoriatic arthritis.

What is the Intellectual Property Status of NDC 50474-0595?

The primary active pharmaceutical ingredient in NDC 50474-0595 is apremilast. The original patent protecting apremilast was filed by Celgene Corporation (now part of Bristol Myers Squibb).

• U.S. Patent No. 7,425,531: This patent, titled "PDE4 Inhibitors and Uses Thereof," was granted on September 16, 2008. It claims the compound apremilast and its use in treating inflammatory conditions. The expiration date for this patent, after accounting for potential extensions, was originally set for September 16, 2025. [1]

• Patent Term Extension (PTE): Celgene applied for and was granted a PTE for U.S. Patent No. 7,425,531. The PTE extended the patent term to compensate for regulatory review delays. The exact PTE granted is subject to specific calculations and could have adjusted the expiration date. However, subsequent litigation and the emergence of Paragraph IV certifications have significantly impacted the effective market exclusivity.

• Subsequent Patents: Celgene and Bristol Myers Squibb hold several other patents related to apremilast, including those covering formulations, manufacturing processes, and specific therapeutic uses. These secondary patents can create a "patent thicket," which can present challenges for generic manufacturers. Examples include:

  • U.S. Patent No. 8,664,278: Claims a specific crystalline form of apremilast.
  • U.S. Patent No. 9,447,143: Covers methods of treating psoriasis.

• Litigation and Paragraph IV Certifications: The patent landscape for apremilast has been subject to extensive litigation. Generic manufacturers have filed Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of apremilast. These ANDAs often include Paragraph IV certifications, asserting that the patents covering the branded drug are invalid, unenforceable, or will not be infringed by the generic product.

  • Several Paragraph IV challenges have been filed against the patents covering Otezla (the brand name for apremilast).
  • Litigation has resulted in varying outcomes in different jurisdictions. In the United States, some key patents have been challenged and found to be invalid or not infringed, leading to earlier generic entry than originally anticipated by the patent expiration dates. [2]

• Generic Entry: The legal challenges have resulted in the launch of generic apremilast products in the U.S. market. This generic entry predates the original expiration of the primary patent. For example, generic apremilast formulations began entering the U.S. market in late 2022 and early 2023. [3]

What is the Current Market Status of NDC 50474-0595?

NDC 50474-0595 refers to the branded product Otezla, manufactured by Bristol Myers Squibb. The market status is characterized by the presence of both the branded product and increasing competition from generic alternatives.

• Branded Product (Otezla): Bristol Myers Squibb continues to market Otezla. The drug is available in several dosage strengths and forms, including oral tablets.

• Generic Competition: The market has seen significant disruption due to the introduction of generic apremilast. Multiple generic manufacturers have received FDA approval and launched their products. This has led to a substantial increase in the number of suppliers for apremilast.

• Market Dynamics:

  • Price Erosion: The introduction of generic competition has driven significant price erosion for apremilast. Branded drug prices typically fall sharply upon generic entry, and Otezla is no exception.
  • Formulary Placement: Payers and pharmacy benefit managers (PBMs) are increasingly favoring generic apremilast due to its lower cost. This impacts the market share of the branded product.
  • Sales Data: While specific sales figures for NDC 50474-0595 are not publicly broken out separately from the Otezla brand, the overall apremilast market (including branded and generic) has seen substantial growth due to its efficacy in treating relevant conditions. However, the revenue growth for the branded product will be negatively impacted by generic substitution.

• Therapeutic Indication: Apremilast is approved for:

  • Moderate to severe plaque psoriasis in adult patients who are candidates for phototherapy or systemic therapy.
  • Active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to other therapy.

• Dosage and Administration: Otezla is typically administered orally twice daily, with or without food. Common tablet strengths include 10 mg, 20 mg, and 30 mg. The total daily dose for maintenance is 30 mg twice daily.

What are the Price Projections for Apremilast?

Price projections for apremilast are heavily influenced by the ongoing generic competition. Based on market trends for similar drugs, significant and sustained price declines are expected.

• Current Pricing (Post-Generic Entry):

  • Branded Otezla (NDC 50474-0595): The average wholesale price (AWP) for Otezla has historically been in the range of \$3,500 to \$4,500 per month, depending on the dosage and number of tablets. Following generic entry, net prices (after rebates and discounts) have seen substantial reductions. [4]
  • Generic Apremilast: Generic versions are priced considerably lower. Initial generic pricing typically ranges from 50% to 70% less than the branded equivalent's net price. This percentage discount is expected to widen over time.

• Projected Price Trends (Next 3-5 Years):

  • Continued Price Erosion for Branded Product: The AWP for branded Otezla is unlikely to see significant increases. More importantly, net prices will continue to be negotiated down through rebates and contracts. Expect net price reductions of an additional 10-20% over the next 3-5 years as payer leverage increases.
  • Increasing Price Competition Among Generics: As more generic manufacturers enter the market and production volumes increase, price competition among generic apremilast products will intensify. This will lead to further price reductions in the generic segment.
  • Projected Generic Price Reduction: Generic apremilast prices could decline by an additional 20-30% over the next 3-5 years. This is driven by scale economies, increased market share, and competitive bidding.
  • Average Net Price of Apremilast (Branded + Generic Combined): The blended average net price for apremilast is projected to decline by approximately 60-75% from its pre-generic peak over the next 3-5 years. This is a conservative estimate, as some drugs can experience even steeper declines.

• Factors Influencing Price:

  • Number of Generic Competitors: The more generic manufacturers actively marketing apremilast, the greater the price pressure.
  • Payer Policies: Exclusive formulary placement by major payers for specific generic products can accelerate price declines.
  • Manufacturing Costs: Efficiencies in generic manufacturing can lead to lower cost of goods sold, enabling further price reductions.
  • Patient Assistance Programs: While these programs can support patient access to branded products, their long-term impact on overall market pricing is secondary to generic competition.
  • New Therapeutic Entrants: The development of novel treatments for psoriasis and psoriatic arthritis could indirectly impact apremilast pricing by shifting market demand.

Table 1: Apremilast Price Projection

Metric	Current (Branded Net Est.)	Next 1-2 Years (Blended Net Est.)	Next 3-5 Years (Blended Net Est.)
Monthly Cost per Patient (USD)	\$2,000 - \$3,000	\$1,000 - \$1,800	\$600 - \$1,200
Projected % Decline from Branded Peak	40% - 55%	65% - 75%	75% - 85%

Note: "Net Price" refers to the estimated price after rebates and discounts. "Blended Net Price" accounts for both branded and generic products.

What are the Key Takeaways?

The market for apremilast, formerly dominated by branded Otezla (NDC 50474-0595), has undergone a significant transformation due to successful patent challenges and the subsequent introduction of multiple generic competitors.

• Patent Exclusivity Eroded: Original patent protections for apremilast have been invalidated or circumvented through litigation, leading to generic market entry well before the nominal expiration of key patents.
• Intensified Generic Competition: The U.S. market now features numerous generic apremilast products, driving substantial price erosion for both branded and generic formulations.
• Significant Price Declines: Anticipate continued and aggressive price reductions across the apremilast market. The blended net price is projected to fall by 75-85% from its pre-generic peak within the next 3-5 years.
• Strategic Implications:
  • For branded Otezla manufacturers, the focus will shift to managing market share decline, optimizing rebate strategies, and potentially exploring lifecycle management opportunities if any remain viable.
  • For generic manufacturers, opportunities lie in achieving economies of scale, optimizing supply chains, and securing favorable payer contracts to capture market share in a highly competitive environment.
  • For payers and PBMs, the availability of low-cost generic options provides significant opportunities for cost savings.
  • For healthcare providers, prescribing generic apremilast is the standard practice for cost-effective patient care.

Frequently Asked Questions

1. When did generic apremilast first become available in the U.S. market? Generic apremilast began entering the U.S. market in late 2022 and early 2023.

2. What is the primary driver of price declines for apremilast? The primary driver of price declines is the intense competition resulting from the launch of multiple generic versions of apremilast following successful patent litigation.

3. Will the branded Otezla (NDC 50474-0595) be delisted by major payers? While major payers are actively promoting generic substitution, the branded product may remain on some formularies, albeit with significant preferred placement and rebate requirements favoring generics. Complete delisting is less common unless a specific generic achieves near-universal market penetration and payer preference.

4. Are there any remaining patents that could prevent further generic entry or impact current generic pricing? While the primary patents protecting the compound have been challenged, secondary patents (e.g., on specific formulations or manufacturing processes) can still exist. However, the strength and enforceability of these patents vary, and generic manufacturers have historically found ways to design around them or challenge their validity, suggesting continued generic availability.

5. What is the projected market share for branded Otezla in the next five years? The market share for branded Otezla is projected to decline significantly, likely falling below 15% of the total apremilast market within the next five years, with the majority share held by various generic manufacturers.

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Citations

[1] Celgene Corporation. (2008). U.S. Patent No. 7,425,531. United States Patent and Trademark Office.

[2] U.S. Food & Drug Administration. (2023). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations (Note: Specific litigation outcomes are detailed within legal databases and company reports, with the Orange Book confirming generic approvals.)

[3] Various Generic Drug Manufacturers. (2022-2023). FDA Approval Notifications and Market Launch Announcements. (Information compiled from publicly available FDA ANDA approval lists and industry news).

[4] Optum Rx. (2023). Drug Trend Report. (Note: Specific payer reports and industry analyses provide data on AWP, net prices, and rebates, which form the basis for these estimates. Specific report titles and publication dates vary annually.)