Last updated: January 2, 2025
Introduction to the Drug
The drug with the NDC code 25021-0813 is identified as Gemcitabine Hydrochloride, a chemotherapeutic agent used in the treatment of various cancers. It is an intravenous injection, powder, lyophilized, for solution, and is labeled and marketed by Sagent Pharmaceuticals[1].
Market Context
Current Market Trends
The pharmaceutical market, particularly for specialty and oncology drugs, is experiencing significant changes. According to Vizient's Pharmacy Market Outlook, drug price inflation is projected to grow at 3.8% in 2024, driven in part by the increasing utilization of specialty pharmaceuticals, including weight loss drugs and gene therapies[3].
Competition and Market Share
Gemcitabine Hydrochloride, being a generic drug, faces competition from other generic versions as well as from the original branded product. However, generic drugs like Gemcitabine Hydrochloride often gain market share due to their cost-effectiveness. For instance, biosimilars, which are biologic equivalents of branded drugs, are expected to increase their market share, although they are projected to see only a 0.55% price increase[3].
Pricing Projections
General Trends
Given the overall trend of increasing drug prices, it is likely that Gemcitabine Hydrochloride will see some level of price inflation. However, as a generic drug, its price increases are generally more modest compared to branded or specialty drugs.
Specific Projections
Vizient's projections indicate that while there will be an overall increase in drug prices, generic and biosimilar drugs are expected to have more stable pricing. This suggests that the price of Gemcitabine Hydrochloride may not rise as sharply as some other pharmaceuticals. A projected increase of around 1-2% could be anticipated, aligning with the broader trend of modest increases for generic medications.
Supply Chain and Availability
Drug Shortages
Drug shortages can significantly impact pricing and availability. While Gemcitabine Hydrochloride itself is not currently listed as being in shortage, other drugs in the same category or from the same manufacturer can face supply chain issues. For example, labetalol injection, another product from Sagent Pharmaceuticals, has faced shortages due to manufacturing delays and discontinuations by other manufacturers[5].
Impact on Pricing
Shortages in related drugs can sometimes drive up prices due to increased demand and reduced supply. However, since Gemcitabine Hydrochloride is not currently in shortage, its pricing is less likely to be directly affected by such factors.
Regulatory Environment
FDA Oversight
The FDA plays a crucial role in regulating drug prices and availability. Drugs like Gemcitabine Hydrochloride, which are approved through the Abbreviated New Drug Application (ANDA) process, are subject to FDA oversight to ensure quality and safety. This regulatory environment helps maintain a stable market but can also influence pricing through approval and manufacturing standards[1].
Economic Factors
Hospital and Healthcare Costs
Hospitals and healthcare providers are under increasing pressure to manage pharmacy expenditures due to rising drug costs. This can lead to more stringent formulary management and a greater emphasis on cost-effective treatments, which could influence the pricing and market share of drugs like Gemcitabine Hydrochloride[3].
Consumer and Patient Impact
Access to Care
The pricing of Gemcitabine Hydrochloride can significantly impact patient access to care. Higher prices can make the drug less accessible to patients, especially those without comprehensive insurance coverage. Conversely, stable or modest price increases can help maintain access to this critical treatment.
Industry Expert Insights
Carina Dolan, associate vice president of clinical oncology, pharmacoeconomics, and market insights at Vizient, highlights the challenges faced by hospitals in managing pharmacy expenditures and the importance of strengthening the supply chain. This underscores the need for careful price management and supply chain optimization for drugs like Gemcitabine Hydrochloride[3].
Illustrative Statistics
- The projected 3.8% increase in drug prices is the highest since July 2019[3].
- Biosimilars made up 24.93% of purchasing volume for originator products and their corresponding biosimilars in 2023[3].
Key Takeaways
- Gemcitabine Hydrochloride is a generic chemotherapeutic agent with a stable market presence.
- The drug is expected to see modest price increases, likely in the range of 1-2%, aligning with broader trends for generic medications.
- Supply chain stability and regulatory oversight are crucial in maintaining the drug's availability and pricing.
- Economic pressures on hospitals and healthcare providers may influence formulary decisions and pricing strategies.
FAQs
Q: What is Gemcitabine Hydrochloride used for?
A: Gemcitabine Hydrochloride is used in the treatment of various cancers, including pancreatic cancer, breast cancer, ovarian cancer, and non-small cell lung cancer.
Q: Who is the manufacturer of Gemcitabine Hydrochloride with NDC 25021-0813?
A: The manufacturer is Sagent Pharmaceuticals.
Q: What is the projected price increase for Gemcitabine Hydrochloride in 2024?
A: The projected price increase is likely to be modest, around 1-2%, following the broader trend for generic medications.
Q: How do drug shortages affect the pricing of Gemcitabine Hydrochloride?
A: While Gemcitabine Hydrochloride itself is not in shortage, shortages in related drugs can sometimes drive up prices due to increased demand and reduced supply.
Q: What role does the FDA play in regulating the pricing of Gemcitabine Hydrochloride?
A: The FDA ensures the quality and safety of the drug through the ANDA approval process, which helps maintain a stable market but can also influence pricing through regulatory standards.
Sources
- FDA.report: NDC 25021-235 - Gemcitabine Hydrochloride.
- SEER Cancer: 25021-0826 Zoledronic Acid.
- Vizient Inc.: Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals.
- DailyMed: LEUCOVORIN CALCIUM injection, powder, lyophilized, for solution.
- ASHP: Drug Shortage Detail: Labetalol Injection.
