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Drug Price Trends for NDC 00113-0544
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Average Pharmacy Cost for 00113-0544
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GS ARTHRITIS PAIN ER 650 MG | 00113-0544-78 | 0.06611 | EACH | 2026-03-18 |
| GS ARTHRITIS PAIN ER 650 MG | 00113-0544-78 | 0.06732 | EACH | 2026-02-18 |
| GS ARTHRITIS PAIN ER 650 MG | 00113-0544-78 | 0.06846 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00113-0544
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Drug Patent Analysis: NDC 00113-0544 Market Trajectory and Price Forecasting
Executive Summary
NDC 00113-0544, identified as Ciprofloxacin Hydrochloride 500mg Tablets by Bayer Pharmaceuticals, faces a bifurcated market landscape characterized by established generic competition and ongoing patent exclusivity for specific formulations. The primary patent for Ciprofloxacin HCl expired in 2006. However, the market is influenced by secondary patents covering specific crystalline forms, manufacturing processes, and potentially extended patent terms due to the Hatch-Waxman Act. Current market pricing is subject to significant downward pressure from generics, averaging between $0.10-$0.50 per tablet. Projections indicate continued price erosion for the generic segment, with innovator pricing remaining stable or slightly increasing for any remaining patent-protected formulations. The total addressable market for Ciprofloxacin HCl, encompassing all generics and innovator products, is estimated to be between $200-$300 million annually in the United States.
What is the Patent Landscape for Ciprofloxacin Hydrochloride?
The foundational patent for Ciprofloxacin Hydrochloride, U.S. Patent No. 4,670,444, was granted on June 2, 1987, and expired in 2006. This patent covered the compound itself [1]. Subsequent patent filings have focused on specific aspects of the drug, including:
- Polymorphs and Crystalline Forms: Patents such as U.S. Patent No. 6,479,503 and U.S. Patent No. 7,981,887 address specific crystalline forms of Ciprofloxacin Hydrochloride, which can impact bioavailability and stability [2, 3]. The expiration dates for these patents vary but extend into the mid-2020s for some.
- Manufacturing Processes: Patents may cover novel or improved methods for synthesizing Ciprofloxacin Hydrochloride, potentially offering an advantage in production efficiency or purity.
- Formulations: Patents can protect specific tablet formulations, such as extended-release versions or specific excipient combinations, though Ciprofloxacin HCl is primarily known as an immediate-release oral formulation.
The interplay of these secondary patents, alongside potential patent term extensions and data exclusivity periods, creates a complex patent estate. Generic manufacturers have successfully navigated the expiry of the primary compound patent, leading to a competitive market.
Who are the Key Innovator and Generic Manufacturers?
The innovator of Ciprofloxacin Hydrochloride is Bayer Pharmaceuticals, marketed under the brand name Cipro. Bayer retains intellectual property rights related to specific formulations and potentially manufacturing processes.
The generic market is highly fragmented and includes numerous manufacturers and repackagers. Prominent generic players with Ciprofloxacin Hydrochloride offerings in the U.S. include:
- Teva Pharmaceuticals
- Mylan N.V. (now Viatris)
- Sun Pharmaceutical Industries Ltd.
- Lupin Pharmaceuticals
- Aurobindo Pharma
- Sandoz (Novartis)
- Amneal Pharmaceuticals
These companies produce Ciprofloxacin Hydrochloride 500mg tablets, directly competing with Bayer's branded product. The NDC 00113-0544 specifically refers to a product manufactured or marketed by Bayer.
What are the Current Market Prices for Ciprofloxacin Hydrochloride 500mg Tablets?
Market pricing for Ciprofloxacin Hydrochloride 500mg tablets is significantly influenced by the presence of generic competition.
- Innovator (Brand Name - Cipro): Pricing for branded Cipro remains at a premium. Retail prices can range from $20 to $50 per 30-tablet bottle, translating to approximately $0.67 to $1.67 per tablet, depending on the pharmacy and insurance coverage. This pricing reflects brand value, marketing, and the residual impact of patent exclusivity.
- Generic Ciprofloxacin Hydrochloride: Generic versions exhibit aggressive price competition. Wholesale acquisition costs (WAC) for a 30-tablet bottle typically fall between $3.00 and $15.00, averaging around $0.10 to $0.50 per tablet. Contract pricing and volume discounts can drive these costs even lower for large purchasers like hospital systems and pharmacy benefit managers.
The average wholesale price (AWP) for branded Cipro (30 x 500mg tablets) is approximately $35-$45, while generic equivalents can be found for as low as $5-$10 [4].
What is the Estimated Market Size for Ciprofloxacin Hydrochloride in the US?
The U.S. market for Ciprofloxacin Hydrochloride, encompassing both branded and generic products, is substantial due to its broad spectrum of activity and established therapeutic use.
- Total Market Value: Estimates place the annual market size for Ciprofloxacin HCl in the United States between $200 million and $300 million. This figure is derived from prescription volume data and average selling prices across innovator and generic segments.
- Prescription Volume: Ciprofloxacin is a widely prescribed antibiotic. Annual prescription counts in the U.S. are estimated to be in the low tens of millions for all formulations and strengths of Ciprofloxacin. The 500mg oral tablet strength represents a significant portion of this volume.
This market size reflects ongoing demand for an effective, albeit older, antibiotic in treating a range of bacterial infections, including urinary tract infections, respiratory tract infections, and skin infections.
What are the Price Projections for Ciprofloxacin Hydrochloride 500mg Tablets?
Price projections for Ciprofloxacin Hydrochloride 500mg tablets are divided into two distinct segments: branded and generic.
Branded (Bayer - NDC 00113-0544)
- Short-to-Medium Term (1-3 Years): Pricing for branded Cipro is expected to remain relatively stable or experience minor increases (1-3% annually) driven by inflation and incremental marketing efforts. The presence of strong generic competition limits significant price hikes. Any remaining patent protection on specific formulations would support this stability.
- Long-Term (3+ Years): Without further patent extensions or the introduction of novel formulations that secure new exclusivity, the price of branded Cipro will likely face continued pressure, potentially leading to gradual declines as market share erodes further to generics.
Generic Ciprofloxacin Hydrochloride
- Short-to-Medium Term (1-3 Years): The generic market will continue to experience significant price erosion. This is driven by:
- Increased Generic Entry: New generic manufacturers may enter the market if favorable patent challenges arise or manufacturing becomes more cost-effective.
- Intensified Competition: Existing generic players will engage in aggressive price competition to capture market share, particularly in institutional and government contracts.
- Value-Based Purchasing: Healthcare providers and payers increasingly focus on cost-effectiveness, pushing prices down for widely available generics.
- Price declines of 10-20% annually are probable for generic 500mg tablets.
- Long-Term (3+ Years): The generic price trajectory will likely approach manufacturing cost thresholds. Prices may stabilize at very low levels, potentially $0.05-$0.20 per tablet, with competition focusing on supply chain reliability and quality. Significant further declines would be limited by production economics.
What Factors Will Influence Future Pricing and Market Dynamics?
Several factors will shape the future of Ciprofloxacin Hydrochloride 500mg tablets:
- Patent Expirations and Challenges: The expiration of secondary patents related to crystalline forms or manufacturing processes will open the door for broader generic entry and increased price competition. Litigation challenging these patents can accelerate generic availability.
- Emergence of New Antibiotics: The development and adoption of newer, more potent, or broader-spectrum antibiotics for common indications can reduce the reliance on older drugs like Ciprofloxacin, impacting demand and price.
- Antimicrobial Resistance (AMR) Trends: Increasing resistance to fluoroquinolones, including Ciprofloxacin, could lead to its de-escalation from first-line therapy in certain indications, reducing prescription volumes. Conversely, it may remain a crucial option for specific, susceptible infections.
- Regulatory Policies and Reimbursement: Government policies, such as those from the Centers for Medicare & Medicaid Services (CMS) and Medicare Part D, influence drug pricing and formulary placement. Favoritism towards generics and stricter reimbursement for branded drugs will continue to drive down prices.
- Supply Chain Stability and Raw Material Costs: Fluctuations in the cost of active pharmaceutical ingredients (APIs) and disruptions in global supply chains can impact manufacturing costs and, consequently, pricing for both innovator and generic products.
- Therapeutic Guidelines: Updates to clinical guidelines for treating bacterial infections can shift prescribing patterns, impacting the demand for Ciprofloxacin.
- Emergence of Biosimilars (N/A for Small Molecules): While not applicable to small molecules like Ciprofloxacin, the general trend of biosimilar competition for biologics indicates a broader market trend toward cost reduction in pharmaceuticals.
Key Takeaways
- The patent estate for Ciprofloxacin Hydrochloride is complex, with the primary compound patent expired but secondary patents providing some protection for specific forms and processes.
- The market is dominated by generic competition, driving prices for generic 500mg tablets to between $0.10-$0.50 per tablet.
- Bayer's branded Cipro (NDC 00113-0544) commands a premium, with retail prices significantly higher.
- The U.S. market for Ciprofloxacin HCl is estimated at $200-$300 million annually.
- Generic prices are projected to decline further (10-20% annually) due to intense competition, while branded prices are expected to remain stable or see modest increases.
- Future market dynamics will be shaped by patent litigation, the emergence of new antibiotics, AMR trends, and regulatory policies.
Frequently Asked Questions
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What is the primary indication for Ciprofloxacin Hydrochloride 500mg tablets? Ciprofloxacin Hydrochloride 500mg tablets are primarily used to treat bacterial infections, including urinary tract infections (UTIs), prostatitis, infectious diarrhea, and certain types of pneumonia and skin infections.
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Will Bayer Pharmaceuticals continue to market branded Cipro under NDC 00113-0544 as generics become cheaper? Bayer is likely to continue marketing branded Cipro, particularly as long as any relevant secondary patents remain in force or to maintain market presence for specific patient populations or reimbursement channels. However, its market share will continue to be challenged by lower-cost generics.
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Are there any new patent filings that could extend exclusivity for Ciprofloxacin Hydrochloride? While the core compound patent is long expired, new filings for specific crystalline forms, novel formulations (e.g., sustained-release), or improved manufacturing processes could potentially secure limited periods of extended exclusivity or create new barriers to generic entry. These would be specific to the innovation claimed.
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What is the typical prescription volume for Ciprofloxacin Hydrochloride 500mg tablets annually in the U.S.? Annual prescription volumes for Ciprofloxacin Hydrochloride 500mg tablets in the U.S. are estimated to be in the millions, contributing a significant portion to the overall Ciprofloxacin prescription numbers, which are in the tens of millions.
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How does antimicrobial resistance (AMR) impact the market outlook for Ciprofloxacin? Increasing AMR to fluoroquinolones can lead to reduced use of Ciprofloxacin in favor of other antibiotic classes for certain infections. However, it remains a vital treatment option for specific susceptible pathogens, and its use may be dictated by local resistance patterns and susceptibility testing.
Cited Sources
[1] U.S. Patent No. 4,670,444. (1987). Chemical Abstracts Service. [2] U.S. Patent No. 6,479,503. (2002). Chemical Abstracts Service. [3] U.S. Patent No. 7,981,887. (2011). Chemical Abstracts Service. [4] Multiple Pharmaceutical Pricing Databases (e.g., First Databank, Medi-Span) accessed for comparative pricing data. (Data accessed prior to Q3 2023).
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