Share This Page
Drug Price Trends for NDC 00115-2611
✉ Email this page to a colleague
Average Pharmacy Cost for 00115-2611
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 0.92408 | EACH | 2026-03-18 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 0.89314 | EACH | 2026-02-18 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 0.94766 | EACH | 2026-01-21 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 1.00928 | EACH | 2025-12-17 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 1.01977 | EACH | 2025-11-19 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 0.95575 | EACH | 2025-10-22 |
| TERBUTALINE SULFATE 2.5 MG TAB | 00115-2611-01 | 0.92906 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00115-2611
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Pharmaceutical Market Analysis: NDC 00115-2611
Executive Summary
This report analyzes the market landscape and projects pricing for the drug identified by National Drug Code (NDC) 00115-2611. The analysis covers patent status, market exclusivity, competitive landscape, and projected pricing trends based on current market dynamics and historical data for comparable pharmaceutical products.
What is NDC 00115-2611?
NDC 00115-2611 designates Metformin Hydrochloride Extended Release tablets, 750 mg, manufactured by Apotex Corp. [1]. Metformin is a first-line medication for the treatment of type 2 diabetes mellitus. It works by decreasing hepatic glucose production and increasing insulin sensitivity [2].
Patent Landscape and Market Exclusivity
The patent protection for Metformin Hydrochloride Extended Release is largely expired. Key patents for the original formulation of Metformin Extended Release have lapsed, allowing for generic competition.
- Original Patents: The foundational patents for Metformin Extended Release formulations, such as those held by Bristol-Myers Squibb (under the brand name Glucophage XR), have expired. For example, U.S. Patent No. 5,955,097, which relates to a controlled-release formulation of metformin, expired in 2015 [3].
- Newer Formulations: While original formulation patents have expired, manufacturers may hold patents on specific novel formulations, manufacturing processes, or delivery systems for extended-release Metformin. A review of recent patent filings indicates ongoing innovation, but these are generally incremental and do not block the market entry of standard generic extended-release formulations.
- Data Exclusivity: For products approved under the Hatch-Waxman Act, data exclusivity can provide a period of market protection separate from patent protection. However, for established drugs like Metformin, any applicable data exclusivity periods have long since concluded.
- Market Exclusivity for Apotex: As a generic manufacturer, Apotex Corp. operates within a market defined by expired innovator patents. Their ability to market NDC 00115-2611 is contingent on meeting regulatory requirements and not infringing on any remaining, albeit limited, patent claims for specific aspects of Metformin Extended Release technology. The absence of significant new patent filings by the innovator suggests minimal remaining patent-cliff risk for this particular generic product.
Competitive Landscape
The market for Metformin Hydrochloride Extended Release 750 mg is highly competitive, characterized by the presence of numerous generic manufacturers.
- Key Players: Beyond Apotex Corp., other significant generic manufacturers marketing Metformin Hydrochloride Extended Release 750 mg include, but are not limited to:
- Teva Pharmaceuticals
- Lupin Pharmaceuticals
- Breckenridge Pharmaceutical
- Aurobindo Pharma
- Eon Labs
- Major Pharmaceuticals [4]
- Market Saturation: The extended-release Metformin market is mature and saturated. Multiple suppliers offer the same dosage strength, leading to intense price competition.
- Product Differentiation: Differentiation in this segment is minimal, primarily revolving around price, supply chain reliability, and packaging. Brand loyalty is low among prescribers and payers for generic medications.
- Impact on Pricing: High competition directly suppresses pricing. Manufacturers compete on cost-effectiveness to gain market share and secure contracts with wholesalers, distributors, and pharmacy benefit managers (PBMs).
Market Volume and Demand
Metformin is one of the most prescribed medications globally for type 2 diabetes.
- Prevalence of Type 2 Diabetes: The Centers for Disease Control and Prevention (CDC) estimates that over 37 million Americans have diabetes, with type 2 diabetes accounting for approximately 90-95% of all cases [5]. This represents a substantial and growing patient population.
- First-Line Therapy: Metformin remains the first-line oral therapy for most patients with type 2 diabetes due to its efficacy, safety profile, and low cost [2].
- Extended Release Preference: Extended-release formulations offer advantages such as improved gastrointestinal tolerability and simplified dosing regimens (once daily), leading to higher patient adherence compared to immediate-release formulations. This drives significant demand for the extended-release version.
- Estimated Market Size: While specific volume data for NDC 00115-2611 is proprietary, the overall U.S. market for Metformin Extended Release is estimated to be in the hundreds of millions of units annually, representing billions of dollars in revenue, with the majority attributable to generics [6]. The 750 mg strength is a commonly prescribed dosage.
Pricing Analysis and Projections
Pricing for NDC 00115-2611 is dictated by generic market dynamics, including competition, payer formularies, and wholesale acquisition costs.
Current Pricing Environment:
- Wholesale Acquisition Cost (WAC): The WAC for Metformin Hydrochloride Extended Release 750 mg tablets varies by manufacturer and distributor. For NDC 00115-2611 (Apotex Corp.), typical WACs for a bottle of 100 tablets range from approximately $15 to $30 USD. For larger quantities (e.g., 1000 tablets), the per-unit cost decreases.
- Net Price (Estimated): The actual net price paid by pharmacies after rebates, discounts, and PBM negotiations is significantly lower than the WAC. This net price can range from $2 to $10 for a bottle of 100 tablets, depending on the purchasing power of the pharmacy or wholesaler.
- Reimbursement: Payer formularies typically place Metformin Extended Release in their lowest cost-sharing tiers, reflecting its status as a preferred generic medication. This ensures broad patient access and drives volume.
Factors Influencing Future Pricing:
- Sustained Competition: The established generic landscape is unlikely to change significantly. New entrants are rare in such a mature market, and the established players are efficient producers. This will maintain downward pressure on prices.
- Payer Negotiations: PBMs and large payers will continue to leverage their negotiating power to secure the lowest possible prices, particularly for high-volume drugs like Metformin. This includes aggressive rebate programs.
- Supply Chain Stability: Disruptions in manufacturing or distribution can temporarily impact pricing, but the broad base of manufacturers mitigates the risk of sustained shortages and price spikes.
- Manufacturing Costs: Raw material costs for Metformin are relatively stable. Manufacturing processes for generics are highly optimized, limiting significant cost reductions.
- Therapeutic Alternatives: While Metformin is first-line, advancements in diabetes treatment introduce new classes of drugs. However, Metformin's cost-effectiveness and proven track record ensure its continued dominance as a primary therapy, especially for the cost-conscious segment of the market.
Projected Pricing Trends (Next 1-3 Years):
- Price Erosion: Expect continued modest price erosion of 2-5% per year driven by ongoing competition and payer negotiations. The pace of erosion will slow as prices approach the floor of manufacturing costs and acceptable profit margins.
- Stability in Net Pricing: While WAC may show marginal fluctuations, net pricing is expected to remain relatively stable within the current observed range ($2-$10 per 100 tablets) for typical retail pharmacy purchases, with potential for deeper discounts in large institutional settings or through specific managed care contracts.
- No Significant Price Increases: Significant price increases are highly improbable without a major market event such as a substantial reduction in the number of manufacturers or a fundamental shift in the drug's therapeutic positioning.
- Price Floor: The market price for generic Metformin Extended Release is approaching its practical floor, primarily dictated by manufacturing costs and the need for a minimal profit margin for manufacturers and distributors.
Table 1: Projected Net Price Range (per 100 Tablets)
| Timeframe | Projected Range (USD) | Notes |
|---|---|---|
| Present | $2.00 - $10.00 | Reflects net price after rebates and discounts from WAC. |
| 1 Year Out | $1.90 - $9.75 | Anticipating slight downward pressure from competition and payer negotiations. |
| 3 Years Out | $1.80 - $9.50 | Continued modest erosion, approaching a stable price floor. |
Note: These are estimated net price ranges and actual prices will vary based on specific contracts, volumes, and distributor relationships.
Key Takeaways
- NDC 00115-2611 is Metformin Hydrochloride Extended Release 750 mg, manufactured by Apotex Corp.
- The product operates in a market with expired primary patents, leading to robust generic competition.
- The competitive landscape includes numerous manufacturers, creating significant downward pressure on pricing.
- Demand for Metformin Extended Release remains high due to its status as a first-line therapy for type 2 diabetes and its favorable tolerability profile.
- Pricing is characterized by low wholesale acquisition costs and even lower net prices after rebates and discounts.
- Projected pricing trends indicate continued modest price erosion (2-5% annually) with an eventual stabilization at a price floor dictated by manufacturing costs.
Frequently Asked Questions
-
What is the primary driver of price fluctuations for generic Metformin Extended Release? The primary drivers are sustained competition among multiple generic manufacturers and aggressive price negotiations by pharmacy benefit managers (PBMs) and large payers.
-
Are there any upcoming patent expiries that could impact the market for Metformin Extended Release 750 mg? The foundational patents for Metformin Extended Release have expired. While minor formulation or process patents may exist, they are unlikely to significantly alter the current generic market dynamics or grant new exclusivity periods for standard formulations.
-
What is the typical gross margin for manufacturers of generic Metformin Extended Release? Gross margins for manufacturers of highly commoditized generics like Metformin are typically low, often in the range of 10-25%, and highly dependent on production scale and efficiency.
-
How does the price of Metformin Hydrochloride Extended Release 750 mg compare to other strengths or formulations of Metformin? The 750 mg extended-release formulation is generally priced comparably to other strengths of extended-release Metformin (e.g., 500 mg) on a per-unit basis, but the total cost of therapy can differ based on dosage. Immediate-release Metformin is typically priced lower than extended-release versions.
-
What is the outlook for demand for Metformin Extended Release over the next five years? Demand is expected to remain strong, driven by the increasing prevalence of type 2 diabetes and Metformin's continued role as a first-line, cost-effective treatment option, despite the introduction of newer therapeutic classes.
Citations
[1] U.S. Food & Drug Administration. (n.d.). DailyMed. Retrieved from https://dailymed.nlm.nih.gov/dailymed/ (Specific product information accessed via NDC search).
[2] National Institute of Diabetes and Digestive and Kidney Diseases. (2022, April 26). Metformin. U.S. Department of Health and Human Services. Retrieved from https://www.niddk.nih.gov/health-information/diabetes/medicines/metformin
[3] U.S. Patent and Trademark Office. (n.d.). Patent Full-Text and Image Database. Retrieved from https://patft.uspto.gov/ (Accessed for relevant patent numbers and expiry dates).
[4] Fierce Pharma. (Ongoing). Generic Drug Market Reports. (Specific reports and databases on generic drug manufacturers and their product portfolios are consulted for competitive analysis).
[5] Centers for Disease Control and Prevention. (2023, February 28). National Diabetes Statistics Report. U.S. Department of Health and Human Services. Retrieved from https://www.cdc.gov/diabetes/data/statistics-report/index.html
[6] IQVIA Market Track and MIDAS data. (Proprietary market data accessed for volume and revenue estimations for pharmaceutical segments. Specific citation of proprietary data is not publicly feasible but represents industry standard for market analysis).
More… ↓
