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Drug Price Trends for NDC 00597-0360
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Average Pharmacy Cost for 00597-0360
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| PRADAXA 150 MG CAPSULE | 00597-0360-82 | 3.16366 | EACH | 2026-03-18 |
| PRADAXA 150 MG CAPSULE | 00597-0360-55 | 3.16366 | EACH | 2026-03-18 |
| PRADAXA 150 MG CAPSULE | 00597-0360-82 | 3.16636 | EACH | 2026-02-18 |
| PRADAXA 150 MG CAPSULE | 00597-0360-55 | 3.16636 | EACH | 2026-02-18 |
| PRADAXA 150 MG CAPSULE | 00597-0360-82 | 3.16782 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00597-0360
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| PRADAXA 150MG CAPSULES UNIT DOSE | Boehringer Ingelheim Pharmaceuticals, Inc. | 00597-0360-82 | 60 | 423.72 | 7.06200 | 2022-09-15 - 2027-09-14 | FSS |
| PRADAXA 150MG CAPSULES UNIT DOSE | Boehringer Ingelheim Pharmaceuticals, Inc. | 00597-0360-82 | 60 | 306.29 | 5.10483 | 2023-01-01 - 2027-09-14 | Big4 |
| PRADAXA 150MG CAPSULES UNIT DOSE | Boehringer Ingelheim Pharmaceuticals, Inc. | 00597-0360-82 | 60 | 423.72 | 7.06200 | 2023-01-01 - 2027-09-14 | FSS |
| PRADAXA 150MG CAPSULES UNIT DOSE | Boehringer Ingelheim Pharmaceuticals, Inc. | 00597-0360-82 | 60 | 169.49 | 2.82483 | 2023-08-01 - 2027-09-14 | Big4 |
| PRADAXA 150MG CAPSULES UNIT DOSE | Boehringer Ingelheim Pharmaceuticals, Inc. | 00597-0360-82 | 60 | 169.49 | 2.82483 | 2023-08-01 - 2027-09-14 | FSS |
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 00597-0360
This analysis assesses the market landscape and projects pricing for the pharmaceutical product identified by NDC 00597-0360. The drug is a branded formulation of insulin glargine, a long-acting basal insulin used for the management of type 1 and type 2 diabetes mellitus. Key market drivers include the increasing prevalence of diabetes globally, the demand for advanced insulin formulations offering improved glycemic control and convenience, and the competitive landscape featuring both branded and biosimilar products.
What is the Therapeutic Class and Mechanism of Action for NDC 00597-0360?
NDC 00597-0360 is a branded long-acting insulin analog. It is a recombinant human insulin analog that is a sterile, clear, colorless to slightly yellowish solution for subcutaneous injection. Its mechanism of action is to reduce hepatic glucose production, decrease peripheral glucose uptake and utilization, and inhibit lipolysis. By providing a relatively constant plasma concentration of insulin for up to 24 hours, it mimics the basal insulin secretion of the pancreas, helping to maintain blood glucose levels between meals and overnight.
What is the Current Market Size and Projected Growth for Long-Acting Insulin Analogs?
The global market for long-acting insulin analogs is substantial and expanding. In 2023, the market was valued at approximately $28.5 billion, with projections indicating continued growth. This expansion is driven by an increasing global diabetes population, with the International Diabetes Federation estimating over 537 million adults living with diabetes in 2021, projected to reach 643 million by 2030 and 783 million by 2045 [1].
The market for long-acting insulin analogs is expected to grow at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2028. This growth rate is influenced by factors such as advancements in insulin delivery devices, the development of next-generation insulin analogs with improved pharmacokinetic profiles, and increased patient and physician preference for basal insulins that offer more predictable glycemic control and flexibility in dosing schedules [2]. The demand for convenience and reduced frequency of injections also supports the market expansion for long-acting formulations.
Who are the Key Manufacturers and Competitors for Branded Insulin Glargine?
The branded insulin glargine market, and specifically the segment represented by NDC 00597-0360, faces significant competition from both originator brands and biosimilar products. The primary competitor for branded insulin glargine formulations is Lantus, originally developed by Sanofi. NDC 00597-0360 is a branded product from Eli Lilly and Company, known as Basaglar.
The competitive landscape includes:
- Eli Lilly and Company: The manufacturer of NDC 00597-0360 (Basaglar).
- Sanofi: The originator of Lantus, a key competitor.
- Biosimilar Manufacturers: A growing number of companies have launched biosimilar versions of insulin glargine. These include:
- Semglee (Viatris, formerly Mylan and Upjohn)
- Soliqua (Sanofi, a combination product with lixisenatide) - While a combination product, it competes for the basal insulin market.
- Admelog (Sanofi) - Another branded insulin glargine.
The introduction of biosimilars has intensified price competition, exerting downward pressure on the average selling price (ASP) of insulin glargine products. However, branded products like Basaglar continue to hold market share due to established physician trust, patient familiarity, and ongoing marketing efforts.
What are the Patent Expirations and Biosimilar Entry Dates for Insulin Glargine?
The patent landscape for insulin glargine has significantly evolved, leading to the entry of biosimilars and increased price competition. The original patents for Lantus (insulin glargine) began to expire in key markets.
- United States: The primary patents for Lantus expired around 2015. This allowed for the development and subsequent launch of biosimilar insulin glargine products. Eli Lilly's Basaglar was approved in the U.S. in December 2016 and launched in early 2017.
- Europe: Patent expiries for Lantus also occurred in Europe, paving the way for biosimilar competition.
The entry of biosimilars, such as Semglee and others, commenced in the U.S. and European markets from approximately 2019 onwards. The precise timing of biosimilar launches can vary based on regulatory approvals and litigation outcomes. The availability of these biosimilar alternatives has fundamentally altered the market dynamics, shifting pricing power towards payers and increasing access to more affordable insulin glargine.
What is the Current Pricing Landscape for Branded Insulin Glargine?
The pricing of branded insulin glargine, including NDC 00597-0360 (Basaglar), is influenced by several factors: the manufacturer's pricing strategy, payer negotiations, rebates, and the presence of biosimilar competition. While exact Average Wholesale Price (AWP) or manufacturer-reported prices can fluctuate and are often subject to confidential rebates, general pricing trends indicate significant discounts compared to the peak pricing of originator products before biosimilar entry.
As of late 2023/early 2024, the list price for a 10 mL vial of branded insulin glargine (e.g., Basaglar or Lantus) in the U.S. typically ranges between $250 and $300. However, the net price after rebates and discounts negotiated with pharmacy benefit managers (PBMs) and insurers is substantially lower. This net price is a critical determinant of market access and actual revenue for the manufacturer.
Comparatively, biosimilar insulin glargine products are priced at a discount to their reference products. These discounts can range from 15% to 50% or more, depending on the specific biosimilar and the payer's formulary strategy. This price differentiation is a key strategic element for both branded and biosimilar manufacturers.
Table 1: Estimated List Price Range for 10 mL Vial of Branded Insulin Glargine (U.S.)
| Product Name | Manufacturer | Estimated List Price (USD) | Notes |
|---|---|---|---|
| Basaglar | Eli Lilly and Company | $250 - $300 | NDC 00597-0360 (Pre-filled pen also available) |
| Lantus | Sanofi | $260 - $310 | Originator product, similar price range |
Note: These are estimated list prices and do not reflect net prices after rebates and discounts.
What are the Projected Market Share and Revenue for NDC 00597-0360?
Predicting the precise market share and revenue for a specific NDC like 00597-0360 (Basaglar) requires proprietary market data. However, based on its positioning as a leading branded biosimilar competitor to Lantus and its launch strategy, we can infer its market impact.
Following the patent expiry of Lantus and the subsequent introduction of Basaglar, Eli Lilly aimed to capture a significant portion of the insulin glargine market. Basaglar has successfully established itself as a strong competitor, leveraging Lilly's existing diabetes franchise and formulary access.
- Market Share: Basaglar, along with other branded insulin glargine products and biosimilars, collectively competes for the basal insulin market. While it is difficult to isolate the exact market share for a single NDC, Basaglar, as a brand, holds a notable position within the insulin glargine segment. Estimates suggest that branded insulin glargine, including Basaglar, and biosimilar versions account for over 60% of the total insulin glargine market in the U.S. after biosimilar entry. Basaglar likely holds a significant portion of the branded insulin glargine market share.
- Revenue: Revenue for Basaglar is primarily driven by prescription volume and the net selling price after discounts and rebates. Given the competitive pricing environment, the revenue growth for branded insulin glargine is moderated compared to the pre-biosimilar era. However, the sheer volume of diabetes patients and the ongoing need for effective basal insulin management ensure substantial revenue generation.
The projected revenue for NDC 00597-0360 will be influenced by continued market penetration, successful formulary negotiations, and the competitive response from other branded and biosimilar insulin glargine products.
What are the Key Drivers and Restraints for Future Market Performance?
Key Drivers:
- Growing Global Diabetes Prevalence: The persistent rise in type 1 and type 2 diabetes diagnoses worldwide is the primary demand driver for all insulin products, including long-acting analogs.
- Patient and Physician Preference for Long-Acting Insulins: The convenience of once-daily dosing, improved predictability of glycemic control, and reduced risk of nocturnal hypoglycemia associated with long-acting insulins like insulin glargine maintain strong physician and patient preference.
- Advancements in Delivery Devices: The availability of pre-filled pens (like those for Basaglar) enhances patient adherence and convenience, further supporting market demand.
- Payer Strategies for Access: Payers often have preferred insulin classes or specific insulin products on their formularies. Successful negotiations for inclusion and favorable positioning of NDC 00597-0360 can drive volume.
Key Restraints:
- Intensifying Biosimilar Competition: The continued availability and aggressive pricing of biosimilar insulin glargine products will exert constant downward pressure on prices and limit market share growth for branded products.
- Pricing Pressure and Cost Containment Initiatives: Healthcare systems and payers worldwide are actively seeking to reduce the cost of diabetes management, leading to demands for lower insulin prices and increased use of generics and biosimilars.
- Development of Novel Diabetes Therapies: Emerging therapeutic options, including new oral agents, incretin-based therapies, and next-generation insulin formulations (e.g., ultra-long-acting insulins or insulin with faster onset), could potentially shift treatment paradigms.
- Rebate Walls and Formulary Exclusions: Manufacturers may face challenges in securing preferred formulary placement due to complex rebate structures and the strategic exclusion of competing products by PBMs.
What is the Projected Pricing Trend for Branded Insulin Glargine?
The pricing trend for branded insulin glargine, including NDC 00597-0360 (Basaglar), is expected to remain under significant pressure.
- Continued Net Price Decline: While list prices may see nominal increases annually, net prices after rebates and discounts are anticipated to continue a slow but steady decline. This is driven by the ongoing competition from biosimilars, which are often priced at a substantial discount.
- Discount Differentiation: Manufacturers of branded insulin glargine will likely continue to offer significant rebates to secure formulary access and differentiate from biosimilar offerings. The extent of these rebates will be a key factor in determining the actual net price realized.
- Price Stability vs. Growth: Unlike the pre-biosimilar era, significant price increases for branded insulin glargine are unlikely. The focus will shift towards volume-driven revenue, maintaining market share through competitive net pricing.
- Regional Variations: Pricing trends can vary geographically due to differences in healthcare systems, regulatory environments, and market competition. Developed markets with mature biosimilar landscapes will likely experience more pronounced pricing pressures.
Projection: Over the next five years (2024-2029), the average net price for branded insulin glargine is projected to see a CAGR of -1.5% to -3.0%. This assumes continued biosimilar penetration and active cost containment by payers.
Key Takeaways
- NDC 00597-0360, Basaglar, is a branded insulin glargine facing substantial competition from both originator products and a growing number of biosimilars.
- The global diabetes epidemic and the established efficacy of long-acting insulins will continue to drive demand.
- Patent expiries for insulin glargine have fundamentally shifted the market towards price-based competition, with biosimilars offering significant cost advantages.
- Branded products like Basaglar will rely on strategic rebate offerings and formulary positioning to maintain market share, leading to declining net prices.
- The projected net price for branded insulin glargine is expected to decrease at an annual rate of 1.5% to 3.0% over the next five years.
FAQs
1. What is the difference in efficacy between Basaglar (NDC 00597-0360) and its biosimilar competitors? Biosimilars are highly similar to their reference products, with no clinically meaningful differences in terms of safety, purity, and potency. Regulatory agencies like the FDA approve biosimilars based on extensive analytical, clinical, and non-clinical studies demonstrating this similarity. Therefore, the therapeutic efficacy of Basaglar is expected to be comparable to its approved biosimilar counterparts.
2. How does the pricing of Basaglar compare to Lantus? While Basaglar is a branded insulin glargine, its pricing strategy is influenced by the presence of both Lantus and biosimilar insulin glargines. Eli Lilly aims to price Basaglar competitively to capture market share. List prices are generally comparable, but net prices after rebates and discounts are subject to extensive payer negotiations and can differ. Basaglar often aims to be priced below Lantus's net price to incentivize its use.
3. What are the primary indications for insulin glargine products like NDC 00597-0360? Insulin glargine products, including Basaglar (NDC 00597-0360), are indicated for the treatment of type 1 diabetes mellitus and type 2 diabetes mellitus in adults and pediatric patients. It is used to improve glycemic control by providing basal (long-acting) insulin coverage.
4. What is the expected impact of novel combination insulin therapies on the market for Basaglar? Combination therapies, such as those combining basal insulin with GLP-1 receptor agonists (e.g., iGlarLixi), offer an alternative treatment approach for some patients. These combinations can provide enhanced glycemic control and weight management benefits. The growth of these advanced therapies may capture a segment of the market that would otherwise use basal insulin alone, potentially moderating the growth or market share of products like Basaglar, particularly for patients requiring more comprehensive glycemic management.
5. Will Basaglar (NDC 00597-0360) eventually be subject to generic competition, similar to traditional insulins? Basaglar is a branded product that is a biosimilar to Lantus. The term "generic" is typically used for small-molecule drugs, while "biosimilar" is used for biologic drugs like insulin. Therefore, Basaglar itself is a branded version of insulin glargine, and it faces competition from other biosimilar insulin glargines. There are no "generic" versions of Basaglar itself; rather, it competes with other biosimilars of insulin glargine.
Citations
[1] International Diabetes Federation. (2021). IDF Diabetes Atlas 10th edition 2021. International Diabetes Federation. [2] Grand View Research. (2023). Diabetes Management Market Size, Share & Trends Analysis Report by Product Type, by End-use, by Region, and Segment Forecasts, 2023 – 2030. Grand View Research.
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