Market Analysis and Price Projections for NDC 59651-0422: Cevimeline Hydrochloride
Introduction
Cevimeline Hydrochloride, identified by the National Drug Code (NDC) 59651-0422, is a medication manufactured by Aurobindo Pharma Limited. This drug is used primarily for the treatment of dry mouth (xerostomia) in patients with Sjögren's syndrome. Here, we will delve into the market analysis and price projections for this medication.
Market Context
Global Prescription Drug Market
The global prescription drug market has seen significant growth over the past few years. According to the ASPE issue brief, prescription drug sales revenues and volumes have increased across various geographic regions. However, the U.S. market stands out with a notable increase in sales revenues, largely driven by higher average prices per unit compared to other countries[3].
U.S. Market Trends
In the U.S., prescription drug prices have been a subject of concern due to their high and increasing costs. The average price per unit of prescription drugs in the U.S. has risen by 14% between 2017 and 2022, significantly higher than the decreases observed in other parts of the world and the OECD[3].
Drug Specifics: Cevimeline Hydrochloride
Manufacturer and NDC
Cevimeline Hydrochloride is manufactured by Aurobindo Pharma Limited and is identified by the NDC 59651-0422. This medication is part of Aurobindo's extensive portfolio of generic and specialty drugs[4].
Therapeutic Use
Cevimeline Hydrochloride is used to treat dry mouth in patients with Sjögren's syndrome, an autoimmune disorder that affects the glands that produce tears and saliva. The drug works by stimulating the salivary glands to produce more saliva.
Market Analysis
Competition
The market for medications treating dry mouth is relatively niche but competitive. Generic versions of drugs like Cevimeline Hydrochloride often face competition from other generic manufacturers and, in some cases, branded products. However, Aurobindo Pharma Limited's strong presence in the generic market and its extensive distribution network help maintain a competitive edge[4].
Pricing Dynamics
Pricing for generic drugs like Cevimeline Hydrochloride is generally more stable compared to branded or specialty drugs. However, the overall trend in the U.S. prescription drug market suggests that prices can fluctuate based on various factors such as production costs, regulatory changes, and market demand.
Regulatory Environment
The pricing and availability of Cevimeline Hydrochloride are influenced by regulatory factors, including FDA approvals and CMS pricing policies. For instance, the CMS ASP Pricing Files provide quarterly updates on the average sales price (ASP) for drugs, which can impact reimbursement rates and, consequently, the market price[5].
Price Projections
Current Trends
Given the current trends in the U.S. prescription drug market, it is likely that prices for generic drugs will remain relatively stable but could see minor adjustments. Vizient's Pharmacy Market Outlook projects a 3.8% overall increase in drug prices, driven mainly by specialty pharmaceuticals, but generic drugs are expected to see more modest changes[2].
Future Outlook
For Cevimeline Hydrochloride specifically, the price is expected to remain stable or see a slight increase. Here are a few key points to consider:
- Generic Market Stability: Generic drugs typically experience less price volatility compared to branded or specialty drugs.
- Regulatory Influence: Any changes in regulatory policies or reimbursement rates by CMS could impact the pricing.
- Market Demand: Changes in demand due to shifts in patient populations or treatment protocols could also influence pricing.
Statistical Insights
- The U.S. prescription drug market has seen an average price increase of 14% between 2017 and 2022, but this is more pronounced in the specialty drug segment[3].
- Generic drugs, including those from Aurobindo Pharma Limited, are expected to see a more modest price increase, if any, due to their competitive nature and regulatory oversight.
Key Takeaways
- Stable Pricing: Cevimeline Hydrochloride is likely to maintain stable pricing due to its generic status and the competitive nature of the market.
- Regulatory Impact: Any significant changes in regulatory policies or CMS pricing files could impact the drug's price.
- Market Trends: The overall trend of increasing drug prices in the U.S. may have a minor impact on generic drugs like Cevimeline Hydrochloride.
FAQs
What is Cevimeline Hydrochloride used for?
Cevimeline Hydrochloride is used to treat dry mouth (xerostomia) in patients with Sjögren's syndrome.
Who manufactures Cevimeline Hydrochloride with the NDC 59651-0422?
Aurobindo Pharma Limited manufactures Cevimeline Hydrochloride with the NDC 59651-0422.
What are the current trends in the U.S. prescription drug market?
The U.S. prescription drug market is experiencing a 3.8% increase in prices, driven mainly by specialty pharmaceuticals, while generic drugs are expected to see more modest changes[2].
How does the regulatory environment impact the pricing of Cevimeline Hydrochloride?
The pricing of Cevimeline Hydrochloride is influenced by regulatory factors such as FDA approvals and CMS pricing policies, which can impact reimbursement rates and market prices[5].
What are the projected price changes for Cevimeline Hydrochloride?
The price of Cevimeline Hydrochloride is expected to remain stable or see a slight increase, influenced by the overall stability of generic drug prices and regulatory oversight.
Sources
- CDC - IIS Code Sets: Table Shows the relationships of vaccine packaging NDCs and provides related info for use as reference data for solutions that leverage NDCs[1].
- Vizient Inc.: Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals[2].
- ASPE Issue Brief: International Market Size and Prices of Prescription Drugs[3].
- FindACode: Aurobindo Pharma Limited - List of Drugs - NDC Labeler/Manufacturer[4].
- CMS: ASP Pricing Files[5].
