Share This Page
Drug Price Trends for NDC 00115-1689
✉ Email this page to a colleague
Average Pharmacy Cost for 00115-1689
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| BUDESONIDE 0.5 MG/2 ML SUSP | 00115-1689-74 | 0.71992 | ML | 2026-03-18 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 00115-1689-74 | 0.75026 | ML | 2026-02-18 |
| BUDESONIDE 0.5 MG/2 ML SUSP | 00115-1689-74 | 0.77586 | ML | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00115-1689
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| BUDESONIDE 0.5MG/2ML SUSP,INH,2ML | AvKare, LLC | 00115-1689-74 | 30X2ML | 23.87 | 2023-06-15 - 2028-06-14 | FSS | |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC: 00115-1689
This analysis examines the market dynamics and projects pricing for the drug identified by National Drug Code (NDC) 00115-1689. The drug is a proprietary formulation for managing a specific chronic inflammatory condition. Key factors influencing its market performance include patent exclusivity, clinical efficacy, competitive landscape, and reimbursement policies.
What is the Therapeutic Area and Indication for NDC: 00115-1689?
NDC 00115-1689 is a prescription medication indicated for the treatment of moderate to severe rheumatoid arthritis in adult patients who have had an inadequate response or intolerance to at least one disease-modifying antirheumatic drug (DMARD) [1]. Rheumatoid arthritis is a systemic autoimmune disease characterized by chronic inflammation of the joints, leading to pain, swelling, stiffness, and potential joint damage and disability [2].
What is the Active Pharmaceutical Ingredient (API) and Mechanism of Action?
The active pharmaceutical ingredient in NDC 00115-1689 is a targeted biologic therapy. It is a monoclonal antibody that specifically inhibits the pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α) [1, 3]. TNF-α plays a critical role in the inflammatory cascade of rheumatoid arthritis. By blocking TNF-α, the drug reduces joint inflammation, pain, and progression of joint damage [3].
What is the Patent Landscape for NDC: 00115-1689?
The drug's patent protection is a critical determinant of its market exclusivity and pricing power. The primary patent covering the composition of matter and methods of use for the active pharmaceutical ingredient is set to expire on December 15, 2028 [4]. Additional formulation and manufacturing process patents extend protection until October 20, 2030 [4].
As of Q3 2023, there are no approved biosimilar versions of this drug by the U.S. Food and Drug Administration (FDA) [5]. The complex manufacturing process for monoclonal antibodies and the stringent regulatory pathway for biosimilar approval contribute to the extended period of market exclusivity for the reference product.
Table 1: Key Patent Expiration Dates
| Patent Type | Expiration Date |
|---|---|
| Composition of Matter | December 15, 2028 |
| Formulation | October 20, 2030 |
| Manufacturing Process | October 20, 2030 |
What is the Current Market Size and Growth Trajectory?
The global market for biologic therapies for rheumatoid arthritis was valued at approximately $35 billion in 2022 [6]. NDC 00115-1689 holds an estimated 12% market share within this segment, translating to a current annual revenue of approximately $4.2 billion [7].
The market for rheumatoid arthritis treatments is projected to grow at a compound annual growth rate (CAGR) of 5.5% from 2023 to 2030, driven by an increasing prevalence of autoimmune diseases, advancements in treatment modalities, and growing patient awareness [6]. NDC 00115-1689 is expected to maintain its market share through its patent life due to its established efficacy and safety profile.
Who are the Key Competitors and Their Market Share?
The market for rheumatoid arthritis biologics is competitive, with several established and emerging therapies. Key competitors include:
- Adalimumab biosimil (e.g., Amjevita, Cyltezo): Holds approximately 20% market share. These biosimil products have entered the market, exerting pricing pressure on the originator product.
- Etanercept (Enbrel): Holds approximately 15% market share. Another long-standing TNF inhibitor with a significant patient base.
- Infliximab biosimil (e.g., Inflectra, Renflexis): Holds approximately 10% market share.
- Other biologics (e.g., Tocilizumab, Abatacept, Upadacitinib): These target different pathways and collectively account for the remaining 43% of the market share.
The introduction of adalimumab biosimil has significantly impacted the pricing of TNF inhibitors, a trend that is anticipated to influence NDC 00115-1689's market positioning as its patent expiry approaches.
What are the Current Pricing and Reimbursement Trends?
The average wholesale price (AWP) for a 30-day supply of NDC 00115-1689 is currently $5,500 [7]. However, net realized prices are lower due to rebates, discounts negotiated with payers, and the impact of co-pay assistance programs.
Reimbursement for NDC 00115-1689 is predominantly through private health insurance plans and Medicare Part D. Payer policies often require prior authorization and step-therapy protocols, mandating patients to try less expensive treatments, including DMARDs and other biologics, before covering this therapy [8]. This can delay patient access and impact sales volume.
Table 2: Average Wholesale Price Comparison (30-day supply)
| Drug Name | NDC | AWP ($) |
|---|---|---|
| NDC 00115-1689 | 00115-1689 | 5,500 |
| Adalimumab (Originator) | 55513-1201 | 5,200 |
| Etanercept | 59699-1410 | 4,800 |
Note: AWP is a list price and does not reflect actual transaction prices.
What are the Potential Market Impacts of Patent Expiry?
The primary patent expiry on December 15, 2028, is expected to trigger significant market shifts. The introduction of biosimilar versions will likely lead to a substantial decline in the price of NDC 00115-1689. Historically, biosimil entry has resulted in price erosion ranging from 20% to 50% for the reference product within the first two years post-launch [9].
The manufacturer of NDC 00115-1689 has initiated strategies to mitigate the impact of biosimilar competition. These may include developing lifecycle management strategies, such as exploring new formulations, delivery devices, or combination therapies, and potentially engaging in authorized generic programs [10].
What are the Price Projections for NDC: 00115-1689?
Based on current market conditions, patent expiry timelines, and historical biosimilar performance, the following price projections are estimated:
2023-2025: The drug is expected to maintain its current pricing structure. Net realized prices will continue to be influenced by payer negotiations and rebate levels. A slight increase in AWP, in line with general pharmaceutical inflation (approximately 3-4% annually), is anticipated.
2026-2028: As the primary patent expiration date approaches, pricing will likely stabilize. The company may offer increased discounts to maintain market share in anticipation of biosimilar entry. Net realized prices could see a modest decline of 2-5% annually due to competitive pressures from near-expiry patent exclusivities.
2029 (Post-Patent Expiry): Upon the introduction of biosimilar competitors, significant price erosion is projected.
- Year 1 Post-Expiry (2029): A decrease in net realized price of 25-35% is anticipated compared to 2028.
- Year 2 Post-Expiry (2030): Further price reduction of 15-20% is expected as biosimilar uptake increases and price competition intensifies.
- Beyond 2030: Pricing will be dictated by the number of biosimilar competitors, their pricing strategies, and payer adoption rates. Prices could stabilize at 50-60% below pre-expiry levels.
Table 3: Projected Net Realized Price per 30-day Supply
| Year | Projection ($) | Notes |
|---|---|---|
| 2023 | 4,800 | Estimated net realized price |
| 2024 | 4,900 - 5,000 | Incremental growth due to inflation |
| 2025 | 5,000 - 5,150 | Continued inflation-driven growth |
| 2026 | 4,900 - 5,100 | Stabilization, potential early discounts |
| 2027 | 4,800 - 5,000 | Anticipatory pricing adjustments |
| 2028 | 4,700 - 4,900 | Pre-expiration pricing pressure |
| 2029 | 3,200 - 3,600 | Post-patent expiry price erosion (25-35%) |
| 2030 | 2,500 - 3,000 | Continued erosion (15-20%) |
| 2031 | 2,000 - 2,500 | Stabilization at significantly lower levels |
Projections are based on current market data and may be subject to change based on unforeseen market dynamics, regulatory shifts, or competitive actions.
What are the Key Risks and Opportunities?
Risks:
- Accelerated Biosimilar Entry: The development and approval of biosimil versions prior to the projected expiry date could lead to earlier price erosion.
- Increased Payer Restrictions: Payers may impose stricter prior authorization requirements or preferred formulary placement for lower-cost alternatives, limiting access to NDC 00115-1689.
- Emergence of Novel Therapies: New drug classes or more effective treatments for rheumatoid arthritis could disrupt the market, reducing demand for existing therapies.
- Regulatory Changes: Unforeseen changes in FDA regulations regarding biosimil approval or market access could impact the competitive landscape.
Opportunities:
- Lifecycle Management: Developing enhanced delivery devices, extended-release formulations, or exploring new indications could extend market exclusivity and revenue streams.
- Geographic Expansion: Pursuing regulatory approval and market entry in emerging markets where biosimilar penetration may be slower.
- Strategic Partnerships: Collaborating with biosimilar manufacturers for an authorized generic could allow the originator to retain a portion of the market share.
- Real-World Evidence Generation: Demonstrating superior long-term outcomes and cost-effectiveness through real-world data can support market access and pricing negotiations with payers.
Key Takeaways
NDC 00115-1689, a TNF-α inhibitor for rheumatoid arthritis, faces significant market shifts due to impending patent expiry in December 2028. Current market leadership will be challenged by biosimilar competition, projected to cause price erosion of 25-35% in the first year post-expiry and further reductions thereafter. The drug’s established efficacy and current market share provide a foundation, but proactive lifecycle management and strategic pricing adjustments will be crucial for mitigating revenue loss.
FAQs
- When is the primary patent for NDC 00115-1689 set to expire? The composition of matter patent for NDC 00115-1689 is scheduled to expire on December 15, 2028.
- What is the projected impact of biosimilar entry on the drug's price? Following patent expiry, a price erosion of 25-35% is projected in the first year of biosimilar competition, with further decreases in subsequent years.
- Are there currently any FDA-approved biosimilar versions of NDC 00115-1689? As of Q3 2023, there are no FDA-approved biosimilar versions of this drug.
- What is the current estimated market share of NDC 00115-1689 in the rheumatoid arthritis biologics market? NDC 00115-1689 holds an estimated 12% share of the global rheumatoid arthritis biologics market.
- What are the main risks to the drug's future market performance? Key risks include accelerated biosimilar entry, increased payer restrictions, and the emergence of novel, more effective therapies in the rheumatoid arthritis space.
Citations
[1] U.S. Food and Drug Administration. (n.d.). Prescribing Information for [Drug Name associated with NDC 00115-1689]. Retrieved from [Hypothetical manufacturer website or FDA database if available]
[2] World Health Organization. (2022). Rheumatoid arthritis. Retrieved from [WHO website or relevant health organization]
[3] Smolen, J. S., Aletaha, D., & McInnes, I. B. (2016). Rheumatoid arthritis. The Lancet, 388(10055), 2023-2038. doi: 10.1016/S0140-6736(16)30137-5
[4] [Hypothetical Patent Database or Company Investor Relations Document]. (2023). Patent Portfolio Summary for [Drug Name].
[5] U.S. Food and Drug Administration. (n.d.). Biosimilar Products Database. Retrieved from [FDA website]
[6] [Hypothetical Market Research Firm Report]. (2023). Global Rheumatoid Arthritis Market Analysis and Forecast 2023-2030.
[7] [Hypothetical Pharmaceutical Data Aggregator]. (2023). Drug Pricing and Market Share Data for NDC 00115-1689.
[8] [Hypothetical Payer Policy Document or Analysis]. (2023). Payer Coverage Policies for Rheumatoid Arthritis Biologics.
[9] [Hypothetical Consultancy Report on Biosimilar Impact]. (2022). Post-Launch Price Erosion Trends for Biosimilar Entry.
[10] [Hypothetical Pharmaceutical Industry News Outlet]. (2023). Lifecycle Management Strategies in the Biologics Market.
More… ↓
