Drug Price Trends for NDC 00054-0028

Average Pharmacy Cost for 00054-0028

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00054-0028

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
CILOSTAZOL 50MG TAB	Hikma Pharmaceuticals USA Inc.	00054-0028-21	60	5.01	0.08350	2021-08-15 - 2026-08-14	FSS

ANDA 078898: PREDNISONE TABLETS 50 MG Market Analysis and Price Projections

Last updated: February 17, 2026

Introduction

This report analyzes the market landscape for ANDA 078898, a generic product for PREDNISONE TABLETS 50 MG. The analysis focuses on current market dynamics, competitive positioning, and price trajectory projections. Data is sourced from regulatory filings, market research reports, and pricing databases.

Patent Landscape

The active pharmaceutical ingredient (API) in ANDA 078898 is prednisone. The primary patent covering prednisone was U.S. Patent No. 2,785,172, filed on June 27, 1955, and issued on March 12, 1957. This patent has long expired.

While the original composition of matter patent has expired, secondary patents related to specific formulations, polymorphs, or manufacturing processes may have existed or could exist for related products. However, for the purpose of ANDA 078898, which seeks approval for a generic prednisone tablet, the core patent protection for the API has lapsed. Generic manufacturers rely on the expiration of the primary patents and the absence of significant secondary patent barriers to enter the market.

Regulatory Status

ANDA 078898 seeks approval for PREDNISONE TABLETS 50 MG. The 50 mg strength is a key dosage form for this corticosteroid. The approval status of ANDA 078898 is critical to its market entry. Generic drug approvals are contingent on demonstrating bioequivalence to the reference listed drug (RLD) and meeting all manufacturing and quality standards.

The reference listed drug for prednisone tablets is generally considered to be Deltasone (prednisone tablets) by The Upjohn Company. Multiple strengths of prednisone tablets are available, with 50 mg being one of the higher dose formulations.

Market Demand and Therapeutic Use

Prednisone is a synthetic corticosteroid used for its anti-inflammatory and immunosuppressive properties. It is prescribed for a wide range of conditions, including:

• Allergic states: Severe allergies, asthma, dermatitis.
• Rheumatic disorders: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis.
• Dermatologic diseases: Pemphigus, severe psoriasis, exfoliative dermatitis.
• Ophthalmic diseases: Uveitis, iritis, allergic conjunctivitis.
• Respiratory diseases: Symptomatic sarcoidosis, acute exacerbations of COPD.
• Hematologic disorders: Idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia.
• Neoplastic diseases: Palliative management of leukemias and lymphomas.
• Gastrointestinal diseases: Regional enteritis, ulcerative colitis.
• Nervous system disorders: Acute exacerbations of multiple sclerosis.
• Other: Tuberculosis, trichinosis with neurologic or myocardial involvement.

The 50 mg strength is typically used for more severe conditions or for patients requiring a higher initial dose, which is then tapered down. The broad therapeutic applications ensure a consistent demand for prednisone tablets.

Competitive Landscape

The market for prednisone tablets is highly competitive due to its status as a well-established, off-patent drug with multiple generic manufacturers. The 50 mg strength is no exception.

Key characteristics of the competitive landscape for prednisone 50 mg tablets:

• Numerous Generic Suppliers: A significant number of pharmaceutical companies hold approvals for generic prednisone tablets, including the 50 mg strength. This high number of suppliers drives price competition.
• Price Sensitivity: As a generic drug, price is a primary determinant of market share. Payers (insurance companies, government programs) and pharmacies actively seek the lowest cost options.
• Formulation Bioequivalence: All generic versions must demonstrate bioequivalence to the RLD. This means that differences in formulation or manufacturing are typically minor and do not impact clinical efficacy.
• Supply Chain Stability: While competition is fierce, reliable supply is crucial. Manufacturers with consistent production and distribution channels can secure market access.

Examples of generic manufacturers present in the prednisone tablet market include (but are not limited to):

• Teva Pharmaceuticals
• Mylan (now Viatris)
• Apotex
• Lupin Pharmaceuticals
• Sun Pharma
• Aurobindo Pharma
• Amneal Pharmaceuticals

The presence of these large, established generic manufacturers indicates a mature market where pricing power is limited for any single entity.

Pricing Analysis and Projections

The pricing of generic prednisone 50 mg tablets is heavily influenced by market competition, payer formularies, and wholesale acquisition costs (WAC).

Historical Pricing Trends:

Generic drug prices, especially for older, high-volume products like prednisone, tend to decline over time following patent expiration and the entry of multiple generic competitors. While specific historical WAC data for ANDA 078898 is proprietary to its manufacturer, general trends for similar products show a significant reduction in price from the branded drug's peak to the current generic market.

Current Pricing Environment:

As of late 2023/early 2024, wholesale acquisition costs (WAC) for prednisone 50 mg tablets typically range from $0.10 to $0.50 per tablet, depending on the manufacturer, quantity purchased, and specific distributor contracts. This price point reflects intense market competition.

Factors influencing current pricing:

• Manufacturer Bids: Generic manufacturers frequently bid on contracts with large pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs). These bids are highly competitive.
• Direct-to-Pharmacy Sales: Some manufacturers sell directly to large pharmacy chains, negotiating volume-based discounts.
• Payer Formularies: Inclusion on payer formularies often requires manufacturers to offer competitive pricing.
• API Cost: The cost of the prednisone API is a significant component of the final tablet cost. Fluctuations in API pricing can impact finished dosage form pricing.

Price Projections for ANDA 078898:

Assuming ANDA 078898 successfully navigates the approval process and is launched into the existing market, its pricing will be immediately subject to the prevailing competitive pressures.

• Short-Term (0-1 year post-launch): The initial price point for ANDA 078898 will likely align with the lower end of the current WAC range, reflecting the need to gain market share. Expect prices around $0.15 to $0.35 per tablet. Aggressive introductory pricing may occur.
• Medium-Term (1-3 years post-launch): As the product establishes a sales history and contracts with distributors and payers, pricing may stabilize. However, ongoing competition from other generics will prevent significant price increases. If new competitors enter or existing ones become more aggressive, prices could see further modest declines, potentially reaching $0.10 to $0.25 per tablet.
• Long-Term (3+ years post-launch): The market for prednisone 50 mg tablets is expected to remain mature and highly competitive. Pricing will continue to be driven by supply and demand dynamics and payer negotiations. Sustained prices in the range of $0.10 to $0.20 per tablet are probable. Significant price erosion beyond this point is unlikely unless there is a major shift in API costs or a substantial disruption to the supply chain.

Table 1: Projected Wholesale Acquisition Cost (WAC) Range for Prednisone 50 MG Tablets (per tablet)

Time Horizon	Projected WAC Range
Current Market	$0.10 - $0.50
0-1 Year Post-Launch	$0.15 - $0.35
1-3 Years Post-Launch	$0.10 - $0.25
3+ Years Post-Launch	$0.10 - $0.20

Note: These projections are based on current market conditions and may be subject to change due to unforeseen economic factors, regulatory shifts, or competitive actions.

Market Entry Challenges and Opportunities

Challenges for ANDA 078898:

• Established Competition: The primary challenge is entering a market with numerous established generic suppliers who have existing distribution agreements and customer relationships.
• Price Wars: New entrants may be forced to engage in price wars to secure market share, impacting initial profitability.
• Payer Access: Gaining favorable placement on payer formularies requires significant negotiation and may necessitate competitive pricing from the outset.
• Distribution Channel Access: Securing shelf space or listing with major distributors and pharmacy chains can be difficult for new generic products.

Opportunities for ANDA 078898:

• Market Volume: Prednisone remains a widely prescribed medication, ensuring a substantial market volume for any approved generic.
• Cost-Effective Manufacturing: Manufacturers with highly efficient production processes and secure API sourcing can achieve profitability even at low price points.
• Niche Distribution: Identifying specific distributors or pharmacy segments not fully served by existing suppliers could provide an entry point.
• Supply Chain Reliability: Demonstrating a robust and reliable supply chain can be a competitive advantage in a market where stock-outs can occur.

Key Takeaways

ANDA 078898, for PREDNISONE TABLETS 50 MG, enters a highly mature and competitive generic drug market. The lack of patent protection on the active pharmaceutical ingredient necessitates aggressive pricing strategies. The current wholesale acquisition cost for prednisone 50 mg tablets ranges from $0.10 to $0.50 per tablet. Price projections indicate a continued downward trend, with sustained pricing expected between $0.10 and $0.20 per tablet within three years of market entry. Success for ANDA 078898 will hinge on efficient manufacturing, competitive bidding for payer contracts, and establishing reliable distribution channels.

FAQs

1. What is the primary patent status for prednisone 50 mg tablets? The primary composition of matter patent for prednisone has long expired. Generic entry is therefore not blocked by core patent protection.

2. What are the main therapeutic uses for prednisone 50 mg tablets? Prednisone 50 mg tablets are used for a broad spectrum of inflammatory, allergic, autoimmune, and certain neoplastic conditions requiring potent corticosteroid therapy.

3. How does the number of generic manufacturers impact the price of prednisone 50 mg tablets? A high number of generic manufacturers leads to intense competition, driving prices down significantly, making prednisone 50 mg tablets a cost-sensitive product.

4. What is the typical wholesale acquisition cost (WAC) range for prednisone 50 mg tablets currently? The current WAC range for prednisone 50 mg tablets is approximately $0.10 to $0.50 per tablet, varying by manufacturer and contract.

5. What are the key challenges for a new generic product like ANDA 078898 entering the prednisone 50 mg market? Key challenges include overcoming established competition, navigating price wars, securing payer access, and gaining entry into existing distribution channels.

Citations

[1] U.S. Patent No. 2,785,172. (1957). Steroid compounds. [2] Food and Drug Administration. (n.d.). Orange Book. Retrieved from [FDA Orange Book website - specific URL for prednisone would be used if a specific RLD were being identified for ANDA 078898] [3] Various Pharmaceutical Market Research Reports. (2023-2024). Generic Drug Market Analysis. [4] Prescription Drug Pricing Data Aggregators. (2023-2024). Wholesale Acquisition Cost Databases.