Market Analysis and Price Projections for NDC 60505-0582: Moxifloxacin Ophthalmic Solution
Product Overview
The drug with the National Drug Code (NDC) 60505-0582 is Moxifloxacin Ophthalmic Solution, a prescription drug labeled and distributed by Apotex Corp. This solution is used for ophthalmic administration and contains the active ingredient Moxifloxacin Hydrochloride, with a strength of 5 mg/mL[2][5].
Market Context
Pharmaceutical Industry Trends
In 2024, the pharmaceutical industry is expected to continue its dominance with small molecule drugs, which include Moxifloxacin. These drugs are favored due to their ease of manufacturing, formulation, and administration, as well as their lower cost compared to biologics. Small molecule drugs are projected to account for over 54.9% of global pharmaceutical sales, driven by their proven safety and efficiency in treating major diseases such as oncology, diabetes, autoimmune, and respiratory diseases[3].
Product Specifics
NDC Details
- NDC Number: 60505-0582
- Product Type: Human Prescription Drug
- Proprietary Name: Moxifloxacin
- Generic Name: Moxifloxacin
- Dosage Form: Solution/Drops
- Route of Administration: Ophthalmic
- Marketing Start Date: July 1, 2017
- Marketing Category: ANDA (Abbreviated New Drug Application)[2][5].
Bioequivalence and Therapeutic Class
Moxifloxacin Ophthalmic Solution is bioequivalent to VIGAMOX®, and it falls under the therapeutic class of Antibacterials (AHFS)[5].
Market Outlook and Price Projections
General Pharmaceutical Market Trends
For the period between January 1, 2025, and December 31, 2025, the overall drug price inflation rate is projected to be 0.00%, indicating a stable pricing environment. However, this does not necessarily reflect the pricing dynamics of specific drugs like Moxifloxacin Ophthalmic Solution[4].
Specific Price Projections
While the Vizient Pharmacy Market Outlook does not provide specific price projections for individual drugs like NDC 60505-0582, it suggests that the market will be influenced by factors such as the increasing adoption of biologics, growing demand for personalized medicine, and the focus on emerging markets. These trends could indirectly affect the pricing and demand for small molecule drugs like Moxifloxacin[3][4].
Cost Considerations
Given that Moxifloxacin Ophthalmic Solution is a generic drug, it is generally priced lower than its brand-name counterparts. The cost-effectiveness of small molecule drugs, combined with their established safety and efficacy profiles, contributes to their continued market presence and affordability[3].
Regulatory and Listing Considerations
NDC Directory Inclusion
The inclusion of NDC 60505-0582 in the FDA's National Drug Code Directory indicates that the product has been listed and reported by the labeler, but it does not imply FDA approval or verification of the information provided. The assignment of an NDC number is a regulatory requirement but does not denote FDA approval[1].
Supply Chain and Distribution
Manufacturer and Distributor
Moxifloxacin Ophthalmic Solution is manufactured and distributed by Apotex Corp. The product is available in a 3ML ophthalmic solution bottle, with specific packaging and storage conditions outlined by the manufacturer[2][5].
Key Takeaways
- Market Dominance: Small molecule drugs, including Moxifloxacin, are expected to continue dominating the pharmaceutical market due to their ease of manufacturing and lower costs.
- Price Stability: The overall drug price inflation rate for 2025 is projected to be stable, but specific price projections for NDC 60505-0582 are not available.
- Regulatory Compliance: The drug is listed in the FDA's NDC Directory, but this does not imply FDA approval.
- Bioequivalence: Moxifloxacin Ophthalmic Solution is bioequivalent to VIGAMOX®, ensuring similar therapeutic effects.
FAQs
1. What is the NDC number for Moxifloxacin Ophthalmic Solution?
The NDC number for Moxifloxacin Ophthalmic Solution is 60505-0582.
2. Who manufactures and distributes Moxifloxacin Ophthalmic Solution?
Moxifloxacin Ophthalmic Solution is manufactured and distributed by Apotex Corp.
3. What is the therapeutic class of Moxifloxacin Ophthalmic Solution?
Moxifloxacin Ophthalmic Solution falls under the therapeutic class of Antibacterials (AHFS).
4. Is Moxifloxacin Ophthalmic Solution FDA-approved?
The inclusion of NDC 60505-0582 in the FDA's NDC Directory does not imply FDA approval. It only indicates that the product has been listed and reported by the labeler.
5. What is the projected price inflation rate for pharmaceuticals in 2025?
The overall drug price inflation rate for 2025 is projected to be 0.00%, indicating a stable pricing environment.
Cited Sources
- FDA National Drug Code Directory - FDA
- NDC 60505-0582 Ophthalmic Solution - FDA.report
- Top 12 Pharmaceutical Industry Trends in 2024 - Global Pharma Tek
- Pharmacy Market Outlook Summer 2024 - Vizient Inc.
- Moxifloxacin Ophthalmic Solution - Apotex
