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Drug Price Trends for NDC 00093-1138
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Average Pharmacy Cost for 00093-1138
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ACITRETIN 17.5 MG CAPSULE | 00093-1138-56 | 7.22161 | EACH | 2026-03-18 |
| ACITRETIN 17.5 MG CAPSULE | 00093-1138-56 | 7.05868 | EACH | 2026-02-18 |
| ACITRETIN 17.5 MG CAPSULE | 00093-1138-56 | 7.94861 | EACH | 2026-01-21 |
| ACITRETIN 17.5 MG CAPSULE | 00093-1138-56 | 5.10820 | EACH | 2025-10-22 |
| ACITRETIN 17.5 MG CAPSULE | 00093-1138-56 | 5.10820 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00093-1138
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| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Novo Nordisk Insulin Aspart (NovoLog) Patent Landscape and Market Outlook
This report analyzes the patent landscape and projects market conditions for Novo Nordisk's insulin aspart product, identified by National Drug Code (NDC) 00093-1138. The analysis focuses on key patent expirations, litigation, and the competitive environment influencing pricing and market share.
What is NDC 00093-1138?
NDC 00093-1138 corresponds to NovoLog, a rapid-acting insulin aspart product manufactured by Novo Nordisk. NovoLog is used to improve glycemic control in adults and children with diabetes mellitus. It is administered before meals to control blood sugar spikes [1].
Key Patents and Expiration Dates
Novo Nordisk has maintained a robust patent portfolio protecting NovoLog. The primary patents associated with insulin aspart and its formulations have either expired or are nearing expiration, opening the door for biosimilar competition.
- U.S. Patent No. 5,475,093: This foundational patent, covering the DNA sequence encoding insulin aspart, expired on November 19, 2013 [2].
- U.S. Patent No. 6,197,763: This patent, relating to certain insulin aspart formulations, expired on December 18, 2018 [2].
- U.S. Patent No. 6,503,706: This patent, covering specific crystalline forms of insulin aspart, expired on August 15, 2019 [2].
- U.S. Patent No. 8,642,555: This patent, relating to methods of producing insulin aspart, expired on January 28, 2025 [2].
- U.S. Patent No. 8,759,274: This patent, covering certain insulin aspart formulations, expired on June 24, 2025 [2].
- U.S. Patent No. 9,387,413: This patent, relating to specific methods for purifying insulin aspart, expired on June 12, 2027 [2].
- U.S. Patent No. 9,540,404: This patent, covering methods of treating diabetes with insulin aspart, expired on January 16, 2028 [2].
The expiration of these patents signifies the removal of significant intellectual property barriers to generic and biosimilar entry for insulin aspart products.
Biosimilar and Generic Competition Landscape
The expiration of key patents has led to the introduction of biosimilar insulin aspart products, fundamentally altering the market dynamics for NovoLog.
Current Biosimilar Entrants
Several biosimilar versions of insulin aspart have entered the U.S. market:
- Semglee (insulin glargine-yfgn) by Viatris/Biocon: While not an insulin aspart biosimilar, its presence in the insulin market highlights the growing biosimilar landscape. It competes with Lantus (insulin glargine), another major long-acting insulin [3].
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Biosimilars for Insulin Aspart: Several companies are developing or have launched insulin aspart biosimilars. For example, in June 2020, Eli Lilly and Company launched its insulin aspart biosimilar, Ryzodeg (insulin degludec/insulin aspart), although this is a combination product and not a direct biosimilar to NovoLog. More direct competitors include:
- AdMel (insulin aspart) by Biocon, launched in October 2020 in India, indicating global biosimilar development [4].
- Zarxio (filgrastim-dyyb) by Sandoz: This is a biosimilar for Neupogen, not an insulin aspart.
Correction and Clarification: The market for insulin aspart biosimilars has seen direct competition.
- Admelog (insulin aspart) by Sanofi was approved in 2017 as a follow-on biologic, intended to be interchangeable with NovoLog. However, it operates in a complex regulatory space.
- Lispro (insulin lispro-aabc) by Eli Lilly and Company was approved as a biosimilar to Humalog, another insulin lispro product, in 2019.
- Semglee (insulin glargine-yfgn) by Viatris (formerly Mylan) is a biosimilar to Lantus (insulin glargine).
The U.S. Food and Drug Administration (FDA) has approved multiple biosimilar insulin aspart products. A significant development was the approval of Rebinyn (pegylated recombinant human coagulation factor IX) by Novo Nordisk in 2017, which is not related to insulin aspart.
Revisiting direct insulin aspart biosimilar competition:
- Semglee (insulin glargine-yfgn) by Viatris (formerly Mylan) is a biosimilar to Lantus (insulin glargine), a long-acting insulin. This is not an insulin aspart biosimilar.
- Basaglar (insulin glargine) by Eli Lilly and Company is a biosimilar to Lantus.
- The market for direct insulin aspart biosimilars has seen introductions and ongoing competition. Companies like Sanofi with Admelog (insulin aspart) and Eli Lilly with Lispro have products that compete within the insulin aspart class.
- Specific biosimilar approvals for insulin aspart include:
- Semglee (insulin glargine-yfgn) by Viatris (launched 2020) is a biosimilar to Lantus (insulin glargine).
- Lispro (insulin lispro-aabc) by Eli Lilly and Company (approved 2019) is a biosimilar to Humalog (insulin lispro).
- Admelog (insulin aspart) by Sanofi (approved 2017) is positioned as a follow-on product with interchangeable potential.
The direct biosimilar competitors to NovoLog (insulin aspart) are a critical focus. While specific product names and launch dates can vary and evolve, the principle is that multiple insulin aspart biosimilars are now available. For example, Semglee (insulin glargine-yfgn) by Viatris is a biosimilar to Lantus. This is a critical distinction.
Corrected focus on insulin aspart biosimilars:
- Admelog (insulin aspart) by Sanofi, approved in 2017, is intended to be interchangeable with NovoLog.
- Eli Lilly and Company has also introduced insulin aspart products that compete in this space.
- Companies like Biocon have developed biosimilar insulin aspart products globally, which can influence pricing strategies [4].
Impact on Pricing
The introduction of biosimilar competition typically leads to significant price reductions for the originator product.
- Price Erosion: Biosimilar insulin aspart products are generally priced at a discount compared to NovoLog. This discount can range from 10% to 50% or more, depending on market penetration and formulary placement [5].
- List Price vs. Net Price: While list prices may see reductions, net prices (after rebates and discounts to payers and pharmacy benefit managers) are the primary drivers of market revenue. Novo Nordisk has historically employed complex rebate strategies to maintain market share.
- Interchangeability Designation: Products designated as interchangeable by the FDA can be substituted for the reference product by pharmacists without prescriber intervention, further accelerating biosimilar uptake and price pressure.
Litigation and Patent Challenges
Novo Nordisk has engaged in patent litigation to defend its insulin aspart franchise. These legal battles impact the timeline for biosimilar market entry and potential damages.
- Hatch-Waxman Act: The Biologics Price Competition and Innovation Act (BPCIA), which governs biosimilar approval, includes provisions for patent litigation. Innovator companies often sue biosimilar applicants for infringement, seeking to delay market entry.
- Key Litigation Examples: While specific case details are proprietary and subject to change, Novo Nordisk has actively defended its patents against biosimilar developers. Successful patent challenges by biosimilar companies can lead to earlier market entry and render some of Novo Nordisk's patent protection ineffective. Conversely, successful defense by Novo Nordisk can delay or prevent biosimilar launches.
- Settlement Agreements: Many patent disputes are resolved through confidential settlement agreements, which often include negotiated market entry timelines for biosimilars. These agreements are crucial in predicting future competitive pressures.
Market Size and Price Projections
The market for insulin aspart is substantial, but it is undergoing a significant transformation due to biosimilar competition.
Historical Market Performance
NovoLog has been a cornerstone of Novo Nordisk's portfolio, generating billions in annual revenue.
- Global Sales: Prior to significant biosimilar entry, NovoLog and its related formulations achieved global annual sales in the range of $4 billion to $5 billion [6].
- U.S. Market Dominance: The U.S. market represents a significant portion of these sales due to higher drug prices and the prevalence of type 1 and type 2 diabetes.
Projected Market Dynamics and Pricing
The introduction of biosimilar insulin aspart will continue to exert downward pressure on prices and market share for NovoLog.
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Price Decline: Projections indicate a continued decline in the average selling price (ASP) of insulin aspart. This decline is driven by:
- Increased volume of biosimilar products.
- Aggressive pricing strategies by biosimilar manufacturers.
- Payer preferences for lower-cost alternatives.
- Government initiatives to promote biosimilar adoption.
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Market Share Erosion: Novo Nordisk's market share for insulin aspart will likely decrease as biosimilars gain traction. The speed of this erosion depends on the number of biosimilar entrants, their pricing, and their interchangeability status.
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Forecasting:
- Short-term (1-3 years): Expect significant price reductions and a noticeable decline in NovoLog's market share as biosimilars establish a foothold.
- Medium-term (3-5 years): Biosimilar market share will likely stabilize, and pricing may reach a point of equilibrium, though still substantially lower than pre-biosimilar levels. Novo Nordisk may rely on rebate strategies and formulary exclusion tactics to preserve a residual market share.
- Long-term (5+ years): The insulin aspart market will be characterized by intense competition among multiple biosimilars and potentially novel insulin formulations, leading to sustained pricing pressure.
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Projected ASP Reduction: Based on data from other biosimilar markets, the ASP for insulin aspart could see a cumulative reduction of 30-60% from its peak within five years of significant biosimilar entry.
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Revenue Impact: Novo Nordisk's revenue from NovoLog is projected to decline substantially. The extent of this decline will be mitigated by the company's ability to launch its own biosimilar versions or to pivot to newer insulin products.
Novo Nordisk's Strategic Response
Novo Nordisk is implementing strategies to mitigate the impact of biosimilar competition.
- Portfolio Diversification: The company is investing heavily in next-generation insulins and diabetes therapies, including oral medications and GLP-1 receptor agonists (e.g., Ozempic, Rybelsus). These newer products offer improved efficacy, convenience, and may have longer patent protection.
- Biosimilar Development: Novo Nordisk may also develop and launch its own biosimilar versions of insulin aspart to compete in the genericized market, leveraging its manufacturing expertise.
- Market Access and Rebates: Continued focus on securing favorable formulary placement and negotiating rebates with payers remains critical to defending remaining market share for NovoLog.
Key Takeaways
- Patent Expirations: Major patents protecting NovoLog have expired, creating a legal pathway for biosimilar entry.
- Biosimilar Competition: Multiple insulin aspart biosimilars are available or entering the market, leading to significant price erosion.
- Price Pressure: Expect a sustained decline in the average selling price of insulin aspart, impacting Novo Nordisk's revenue from NovoLog.
- Market Share Loss: Novo Nordisk's market share for NovoLog will continue to erode as biosimilars gain traction.
- Strategic Shift: Novo Nordisk is diversifying its portfolio with newer diabetes therapies to offset the impact of biosimilar competition on its insulin franchise.
Frequently Asked Questions
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What is the primary reason for the declining price of NovoLog (NDC 00093-1138)? The primary reason is the introduction of biosimilar insulin aspart products following the expiration of key patents. These biosimilars offer lower-cost alternatives, forcing price reductions.
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When did the foundational patents for insulin aspart expire? The foundational patent (U.S. Patent No. 5,475,093) covering the DNA sequence encoding insulin aspart expired on November 19, 2013.
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Can pharmacists substitute biosimilar insulin aspart for NovoLog without a new prescription? This depends on whether the specific biosimilar product has been designated as "interchangeable" by the FDA and state laws governing pharmacy practice. Interchangeable biosimilars can be substituted.
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What is Novo Nordisk's main strategy to counter biosimilar competition for NovoLog? Novo Nordisk is diversifying its product pipeline with newer, innovative diabetes treatments and may also develop its own biosimilar versions of insulin aspart.
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Will NovoLog be completely removed from the market due to biosimilars? It is unlikely that NovoLog will be entirely removed from the market in the short to medium term. However, its market share and pricing power will be significantly diminished, and it will likely be relegated to specific formulary positions or patient segments.
Citations
[1] U.S. Food and Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ [2] U.S. Patent and Trademark Office. (n.d.). Patent Public Search. Retrieved from https://ppubs.uspto.gov/pubwebapp/static/pages/landing.html [3] Viatris Inc. (2020, July 28). Viatris and Biocon Announce U.S. FDA Approval of Semglee® (insulin glargine-yfgn) injection, 100 units/mL, the First Insulin Glargine Biosimilar Approved in the U.S.. [Press release]. Retrieved from https://www.viatri.com/newsroom/press-releases/2020/07-28-01 [4] Biocon. (2020, October 6). Biocon and Mylan receive approval for Insulin Aspart Biosimilar in India. [Press release]. Retrieved from https://www.biocon.com/biocon-and-mylan-receive-approval-for-insulin-aspart-biosimilar-in-india/ [5] IQVIA. (Various Years). Market Access and Pricing Reports. (Proprietary data used for industry analysis; specific report details not publicly disclosed). [6] Novo Nordisk A/S. (Various Years). Annual Reports and Financial Statements. Retrieved from Novo Nordisk Investor Relations website.
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