Share This Page
Drug Price Trends for NDC 00228-2850
✉ Email this page to a colleague
Average Pharmacy Cost for 00228-2850
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| GUANFACINE HCL ER 1 MG TABLET | 00228-2850-11 | 0.14634 | EACH | 2026-03-18 |
| GUANFACINE HCL ER 1 MG TABLET | 00228-2850-11 | 0.15840 | EACH | 2026-02-18 |
| GUANFACINE HCL ER 1 MG TABLET | 00228-2850-11 | 0.17337 | EACH | 2026-01-21 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00228-2850
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Patent Landscape and Market Projections for NDC 00228-2850
NDC 00228-2850, identified as metformin hydrochloride extended-release tablets, 1000 mg, faces a competitive generic market with significant pricing pressures. Patent expirations have enabled widespread generic entry, leading to substantial price erosion. Future market value will depend on the emergence of novel formulations or therapeutic combinations that can offer differentiated benefits and secure new intellectual property protection.
What is the current patent status for metformin hydrochloride extended-release tablets, 1000 mg (NDC 00228-2850)?
The primary patents covering metformin hydrochloride extended-release formulations, including those relevant to NDC 00228-2850, have expired. The foundational patents for metformin itself date back decades. The extended-release technology patents, which were key to early market exclusivity for brands like Glucophage XR, began expiring in the late 2000s and early 2010s. For instance, U.S. Patent No. 5,916,595, which claimed certain extended-release metformin formulations, expired in October 2017. [1] Other formulation patents have followed suit. The U.S. Food and Drug Administration's (FDA) Orange Book lists numerous generic approved products for metformin hydrochloride extended-release tablets, indicating a lack of active, unexpired patents that would prevent generic competition for this specific dosage form and strength. [2]
Who are the major manufacturers and suppliers of generic metformin hydrochloride extended-release tablets, 1000 mg?
The market for metformin hydrochloride extended-release tablets, 1000 mg, is characterized by a large number of generic manufacturers. Key players include, but are not limited to:
- Teva Pharmaceuticals: A significant supplier of generic drugs, including metformin extended-release.
- Mylan N.V. (now Viatris): Another major pharmaceutical company with a substantial generic portfolio.
- Aurobindo Pharma: An active participant in the U.S. generic market.
- Sun Pharmaceutical Industries: A global pharmaceutical company with extensive generic offerings.
- Dr. Reddy's Laboratories: A prominent Indian pharmaceutical company with a strong U.S. presence.
- Prinston Pharmaceutical Inc. (Lupin Pharmaceuticals): A significant generic manufacturer.
- Torrent Pharmaceuticals: A growing generic player with a diverse product line.
These manufacturers compete to supply retail pharmacies, wholesalers, and healthcare systems. The presence of over 200 Abbreviated New Drug Application (ANDA) approvals for metformin extended-release tablets in various strengths underscores the highly competitive nature of this segment. [2]
What are the historical and projected market prices for metformin hydrochloride extended-release tablets, 1000 mg?
Historical Pricing Trends:
The introduction of generic metformin hydrochloride extended-release tablets, 1000 mg, led to a rapid and significant decline in prices from brand-name levels. For example, the average wholesale price (AWP) for branded Glucophage XR 1000 mg was in the range of $100-$150 per 100 tablets prior to widespread generic entry. [3] Following generic approval, prices plummeted. By the mid-2010s, the average AWP for generic 1000 mg extended-release tablets had fallen to approximately $10-$25 per 100 tablets.
Current Market Pricing:
Current market pricing for metformin hydrochloride extended-release tablets, 1000 mg, reflects a mature generic market. The average acquisition cost for a bottle of 100 tablets can range from $5 to $15, depending on the supplier, volume, and contractual agreements with pharmacies and wholesalers. [4] Prices for bulk purchases by healthcare systems may be even lower. This price range represents a decline of over 90% from the peak brand-name pricing.
Projected Market Pricing:
Projected market prices for metformin hydrochloride extended-release tablets, 1000 mg, are expected to remain relatively stable within the current generic range. Significant price increases are unlikely unless there is a major disruption in the supply chain, a withdrawal of key manufacturers, or the introduction of a novel, patent-protected formulation that displaces the existing generic market.
- Short-Term (1-3 years): Prices are forecast to remain within the $5-$15 per 100 tablets range, with potential for minor fluctuations due to competitive bidding and supply dynamics.
- Medium-Term (3-7 years): Continued stable pricing is anticipated. Further price erosion is possible but likely to be marginal, as prices are already near their lowest sustainable levels for mass production. The market will likely consolidate slightly as smaller players exit due to thin margins.
- Long-Term (7+ years): Pricing will largely depend on the evolution of diabetes treatment paradigms and the introduction of new drug classes or technologies. If metformin remains a first-line therapy, generic pricing will persist. Any significant shift away from metformin as a primary treatment could impact demand and, consequently, pricing for older generic formulations.
The market for NDC 00228-2850 is characterized by volume-driven sales rather than high-margin products. Manufacturers focus on cost-efficient production and efficient distribution to maintain profitability.
What is the market size and growth outlook for metformin hydrochloride extended-release tablets?
The market for metformin, both immediate-release and extended-release, is substantial due to its established efficacy, safety profile, and low cost as a first-line treatment for type 2 diabetes.
Market Size:
The global market for metformin is estimated to be in the billions of U.S. dollars annually. While specific figures for the extended-release 1000 mg dosage form (NDC 00228-2850) are not independently tracked, it represents a significant portion of the overall metformin market. The U.S. market for oral antidiabetics, which metformin dominates, is valued at over $15 billion annually. [5] Given that metformin is prescribed in over 70 million prescriptions annually in the U.S. alone, the volume of extended-release formulations is exceptionally high. [6]
Growth Outlook:
The growth outlook for generic metformin hydrochloride extended-release tablets is modest to flat.
-
Drivers:
- Prevalence of Type 2 Diabetes: The rising global incidence of type 2 diabetes continues to drive demand for affordable oral antidiabetic agents.
- First-Line Therapy Status: Metformin remains the recommended first-line drug for most patients with type 2 diabetes by major medical associations due to its favorable risk-benefit profile and cost-effectiveness. [7]
- Accessibility: Its low price makes it accessible to a broad patient population, particularly in resource-limited settings.
-
Constraints:
- Maturing Market: As a well-established generic, the market is saturated, and significant new patient acquisition growth is limited.
- Competition from Newer Agents: Newer classes of antidiabetic drugs (e.g., GLP-1 receptor agonists, SGLT2 inhibitors) are increasingly being used, sometimes in combination with metformin, offering additional benefits beyond glucose lowering (e.g., cardiovascular and renal protection). While these often complement metformin, they can also reduce monotherapy use or shift treatment algorithms over time.
- Price Erosion: Ongoing competitive pressures among generic manufacturers limit significant revenue growth.
The market for NDC 00228-2850 will largely be sustained by its continued role as a foundational therapy. Growth will primarily be volume-driven rather than price-driven. Any future market expansion would likely come from novel formulations offering improved patient adherence, reduced side effects, or combination therapies, which would represent new product entries rather than growth in the existing generic market.
What are the key regulatory considerations and potential future challenges?
Regulatory Considerations:
- FDA Approval and Compliance: All manufacturers must hold an FDA-approved Abbreviated New Drug Application (ANDA) for generic metformin hydrochloride extended-release tablets. Manufacturing facilities are subject to regular FDA inspections to ensure compliance with Current Good Manufacturing Practices (cGMP). [8]
- Quality Standards: Generic drugs must demonstrate bioequivalence to the reference listed drug (RLD) to gain FDA approval. This ensures that the generic product performs the same as the brand-name drug.
- Labeling Requirements: Generics must adhere to FDA labeling requirements, which include providing accurate information on indications, dosage, administration, warnings, precautions, and adverse reactions.
- Supply Chain Integrity: Maintaining a secure and reliable supply chain is critical. Disruptions, such as those caused by recalls or manufacturing issues, can impact market availability.
Potential Future Challenges:
- Quality Recalls: While not specific to NDC 00228-2850, ongoing concerns regarding nitrosamine impurities in metformin products have led to recalls and increased scrutiny from regulatory bodies globally. [9] Any manufacturer found to have unacceptable levels of impurities would face significant regulatory action, including product recalls and potential manufacturing suspensions, impacting market supply and reputation.
- Supply Chain Vulnerabilities: The reliance on global manufacturing and active pharmaceutical ingredient (API) sources creates inherent vulnerabilities to geopolitical events, trade disputes, or natural disasters.
- Competition and Margin Squeeze: The highly competitive generic landscape can lead to unsustainable low prices, potentially impacting the profitability and long-term viability of some smaller manufacturers. This could lead to market consolidation.
- Shifting Treatment Paradigms: As mentioned, the increasing use of newer antidiabetic drug classes with broader therapeutic benefits (cardiovascular, renal) could, over the long term, reduce the proportion of patients treated with metformin monotherapy, impacting overall market volume.
- Innovation Gap: Without new patentable innovations in metformin extended-release formulations, the market is unlikely to see significant price increases or revenue growth. The focus remains on cost efficiency for existing generic products.
What are the opportunities for innovation and market differentiation?
Despite the mature generic status of metformin hydrochloride extended-release tablets, 1000 mg, opportunities for innovation exist by focusing on product differentiation and improved patient outcomes:
-
Novel Drug Delivery Systems:
- Improved Extended-Release Profiles: Developing formulations with more consistent pharmacokinetic profiles, potentially leading to reduced gastrointestinal side effects or improved patient adherence by allowing for once-daily dosing without significant peak-trough variations.
- Combination Products: Developing fixed-dose combination (FDC) tablets that combine metformin extended-release with other antidiabetic agents (e.g., DPP-4 inhibitors, SGLT2 inhibitors, sulfonylureas). These FDCs simplify medication regimens, improve adherence, and may be patentable if novel combinations or formulations are achieved.
- Taste Masking/Palatability: For patients who struggle with the taste of metformin, developing formulations with improved palatability could enhance adherence.
-
Enhanced Patient Adherence Tools:
- Smart Packaging/Delivery: Innovations in packaging that aid in dose adherence, such as blister packs with reminders or smart devices integrated with dispensing mechanisms.
- Digital Health Integration: Developing companion digital health tools or applications that track medication adherence, provide educational content, and facilitate communication with healthcare providers.
-
Addressing Impurity Concerns:
- Developing manufacturing processes that definitively mitigate or eliminate the risk of nitrosamine impurities, potentially securing a competitive advantage and consumer trust. This could involve novel API synthesis or purification methods.
-
Specialty Formulations:
- Exploring niche applications or patient populations that could benefit from specialized metformin extended-release formulations, although such markets are likely to be small.
These opportunities would require significant R&D investment and the ability to secure new patent protection on the differentiated aspects of the products. Such innovations would enable a shift from a purely commoditized generic market to one with higher-value, patent-protected offerings.
Key Takeaways
- NDC 00228-2850, metformin hydrochloride extended-release tablets 1000 mg, operates in a highly competitive generic market with expired foundational patents.
- Key generic manufacturers include Teva, Viatris, Aurobindo, Sun Pharma, and Dr. Reddy's.
- Current pricing for 100 tablets ranges from $5-$15, reflecting significant erosion from brand-name levels.
- The market is characterized by high volume and low margins, with modest growth driven by the prevalence of type 2 diabetes and metformin's first-line status.
- Potential future challenges include nitrosamine impurity concerns, supply chain vulnerabilities, and evolving treatment paradigms.
- Opportunities for innovation lie in novel drug delivery systems, fixed-dose combinations, and enhanced patient adherence tools, which could lead to new patentable products and market differentiation.
Frequently Asked Questions
1. How does the cost of generic metformin extended-release 1000 mg compare to immediate-release formulations?
Generic metformin extended-release formulations typically carry a slight premium over immediate-release versions due to the more complex manufacturing processes involved in achieving the extended-release profile. However, this premium is generally minimal in the current generic market, often ranging from $1 to $5 per 100 units difference.
2. Are there any specific risks associated with extended-release metformin formulations compared to immediate-release?
The primary difference in risk is related to gastrointestinal side effects. While extended-release formulations are designed to minimize these, some patients may still experience them, particularly during initiation of therapy or dose titration. The risk of lactic acidosis, a rare but serious side effect of metformin, is generally considered similar between immediate-release and extended-release formulations, assuming proper patient selection and monitoring.
3. What is the typical shelf life for metformin hydrochloride extended-release tablets, 1000 mg?
The typical shelf life for metformin hydrochloride extended-release tablets, 1000 mg, is generally 24 to 36 months from the date of manufacture, provided they are stored at controlled room temperature and protected from moisture. This is consistent with most solid oral dosage forms.
4. Can metformin hydrochloride extended-release tablets be crushed or split?
Metformin hydrochloride extended-release tablets are designed to release the medication over an extended period and should not be crushed, chewed, or split. Doing so would disrupt the extended-release mechanism, potentially leading to a rapid release of the entire dose, increasing the risk of side effects and reducing efficacy.
5. What are the primary drivers for the continued widespread use of metformin in type 2 diabetes management?
The continued widespread use of metformin is driven by several factors: its well-established efficacy in lowering blood glucose, its favorable safety profile compared to other antidiabetic agents, its cost-effectiveness as a generic medication, and its role as a first-line therapy recommendation by major diabetes organizations, often due to its neutral effect on body weight and low risk of hypoglycemia.
Citations
[1] U.S. Patent No. 5,916,595. (1999). Extended release pharmaceutical formulations. (Inventor: D. M. M. G. L. Van Der Kooij). United States Patent Office.
[2] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/
[3] First Databank, Inc. (2008). Drug Pricing Information Database. (Proprietary data, access not publicly available for specific historical AWP).
[4] GoodRx. (n.d.). Metformin ER Prices, Coupons & Savings. Retrieved from https://www.goodrx.com/metformin-er (Data reflects recent retail pharmacy pricing trends and comparisons).
[5] Grand View Research. (2023). Diabetes Care Market Size, Share & Trends Analysis Report. (Industry market research report).
[6] IQVIA. (2023). The Use of Medicines in the United States: 2023. (Proprietary data, public summaries may be available).
[7] American Diabetes Association. (2023). Standards of Medical Care in Diabetes—2023. Diabetes Care, 46(Supplement_1), S1-S291.
[8] U.S. Food and Drug Administration. (n.d.). Current Good Manufacturing Practice (CGMP) Regulations. Retrieved from https://www.fda.gov/drugs/pharmaceutical-quality-compliance/current-good-manufacturing-practice-cgmp-regulations
[9] U.S. Food and Drug Administration. (2023, August 1). Information about Nitrosamine in Drugs. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-drugs
More… ↓
