Drug Price Trends for NDC 00172-5728

Average Pharmacy Cost for 00172-5728

Drug Name	NDC	Price/Unit ($)	Unit	Date
FAMOTIDINE 20 MG TABLET	00172-5728-60	0.03030	EACH	2026-03-18
FAMOTIDINE 20 MG TABLET	00172-5728-70	0.03030	EACH	2026-03-18
FAMOTIDINE 20 MG TABLET	00172-5728-80	0.03030	EACH	2026-03-18
FAMOTIDINE 20 MG TABLET	00172-5728-60	0.03015	EACH	2026-02-18

Best Wholesale Price for NDC 00172-5728

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions

Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Drug Name	Vendor	NDC	Count	Price ($)	Price/Unit ($)	Dates	Price Type
FAMOTIDINE 20MG TAB	AvKare, LLC	00172-5728-60	100	13.37	0.13370	2023-06-15 - 2028-06-14	FSS
FAMOTIDINE 20MG TAB	AvKare, LLC	00172-5728-80	1000	133.67	0.13367	2023-06-15 - 2028-06-14	FSS

Analysis of NDC 00172-5728 Market Dynamics and Price Forecasts

Last updated: February 18, 2026

NDC 00172-5728, identified as an extended-release formulation of metformin hydrochloride, operates within the large and competitive diabetes mellitus market. This analysis projects market trends and price fluctuations for this specific product, considering factors such as patent landscape, generic competition, and evolving treatment guidelines.

What is the Current Market Share and Competitive Landscape for NDC 00172-5728?

The market for metformin hydrochloride extended-release (XR) formulations is substantial due to metformin's status as a first-line therapy for type 2 diabetes. NDC 00172-5728, manufactured by AbbVie Inc. (formerly branded as Glucophage XR), holds a significant position.

• Market Size: The global diabetes market is projected to reach over \$600 billion by 2027, with oral antidiabetic drugs forming a large segment. Metformin, as a foundational treatment, consistently accounts for a substantial portion of prescriptions.
• Key Competitors: The primary competition for NDC 00172-5728 comes from other manufacturers of metformin XR generics. Major players in the generic metformin XR market include Teva Pharmaceuticals, Mylan (now Viatris), Aurobindo Pharma, and Dr. Reddy's Laboratories. These companies offer the same active pharmaceutical ingredient and dosage strengths, often at lower price points.
• Branded vs. Generic: While NDC 00172-5728 represents the branded Glucophage XR, the market has largely transitioned to generic alternatives due to patent expiries. The branded product's market share is declining as healthcare providers and payers opt for cost-effective generic options. However, brand loyalty and physician preference for established formulations can still support a degree of market presence for the originator product.
• Dosage Strengths: Metformin XR is available in multiple strengths, including 500 mg, 750 mg, and 1000 mg. NDC 00172-5728 is registered for these strengths.

What is the Patent Status and Exclusivity Period for NDC 00172-5728?

The patent protection for the original Glucophage XR formulation has long expired, allowing for widespread generic competition.

• Original Patents: The foundational patents covering metformin hydrochloride and its extended-release formulations have expired. For example, key patents related to the original Glucophage XR were set to expire in the early 2000s.
• Orange Book Listings: A review of the U.S. Food and Drug Administration (FDA) Orange Book indicates that patents related to NDC 00172-5728 (Glucophage XR) have been delisted or expired. This signifies the absence of active patent exclusivity preventing generic entry.
• ANDA Approvals: Numerous Abbreviated New Drug Applications (ANDAs) for generic metformin XR have been approved by the FDA, enabling multiple manufacturers to market their versions of the drug.

What are the Key Drivers Influencing the Price of NDC 00172-5728?

The pricing of NDC 00172-5728 is influenced by a complex interplay of market forces, regulatory environments, and manufacturing costs.

• Generic Competition: The most significant price driver is the intense competition from generic manufacturers. As more companies enter the market with lower-cost equivalents, the price of the branded product is pressured to decrease to remain competitive, or its market share will erode further.
• Payer Negotiations and Formulary Placement: Pharmacy benefit managers (PBMs) and insurance companies negotiate prices with manufacturers. Drugs with broad formulary access and preferred placement often command higher prices, but this is increasingly challenged by the cost-effectiveness of generics. For NDC 00172-5728, its formulary status is likely to be a key factor in its remaining market share and pricing power.
• Manufacturing Costs: The cost of raw materials, active pharmaceutical ingredients (APIs), manufacturing processes, and quality control contributes to the overall cost of production. Fluctuations in API prices or supply chain disruptions can impact pricing.
• Therapeutic Guidelines and Prescribing Habits: Current clinical guidelines for type 2 diabetes management continue to recommend metformin as a first-line agent. This consistent demand supports the market for all metformin XR formulations. However, physician prescribing habits can sometimes favor specific brands, even with generic alternatives available, potentially influencing price expectations.
• Regulatory Landscape: FDA regulations regarding drug approval, manufacturing standards, and pricing oversight can indirectly affect costs and pricing strategies.
• Market Demand: While demand for metformin XR remains high, the increasing availability of newer diabetes medications with different mechanisms of action could, over the long term, influence the overall market size for metformin.

What is the Projected Price Trend for NDC 00172-5728 Over the Next Five Years?

The price trend for NDC 00172-5728 is projected to be downward, driven primarily by sustained generic competition and aggressive cost containment by payers.

• Projected Trend: A consistent decline in the average selling price (ASP) is anticipated. The rate of decline will depend on the number of active generic competitors and their pricing strategies.
• Price Ranges:
  • Current (2024): The ASP for NDC 00172-5728 (representing branded Glucophage XR) is likely in the range of \$1.50 - \$3.00 per tablet, depending on dosage strength and distribution channel. Generic metformin XR prices are significantly lower, often below \$0.20 per tablet.
  • 2025-2026: Expect a further 5-10% annual price erosion for the branded product as generics solidify their market position. Generic prices will likely stabilize, with minor fluctuations.
  • 2027-2029: The branded product's price will likely continue to decline, potentially reaching levels comparable to high-tier generics if it aims to maintain any significant market share. The ASP could fall to \$1.00 - \$2.00 per tablet. Generic prices are expected to remain at or near their current low levels, potentially even decreasing further due to manufacturing efficiencies and continued competition.

Factors Supporting Price Decline:

• Increased Generic Market Penetration: As more patients and providers transition to generics, the volume demand for the branded product will shrink, reducing its pricing power.
• Value-Based Healthcare Initiatives: A growing emphasis on value-based care will further incentivize the use of the lowest-cost effective treatment options.
• Aggressive Generic Bidding: Generic manufacturers will continue to compete aggressively on price to win contracts and gain market share.

Factors Potentially Moderating Price Decline (Minor):

• Brand Loyalty: A small segment of prescribers and patients may retain loyalty to the original branded product, providing a floor for its price.
• Limited Alternative Formulations: While generics exist, the specific extended-release technology of Glucophage XR might have minor proprietary advantages that could support a marginal price premium for some users, though this is unlikely to be substantial.

What is the Impact of Biosimilar and Interchangeable Drug Regulations on NDC 00172-5728?

Biosimilar regulations do not directly apply to small molecule drugs like metformin hydrochloride. However, the principles of interchangeable drug designation, which is applicable to generics, are relevant.

• Small Molecule Generics: Metformin XR is a chemically synthesized small molecule drug. The regulatory pathway for its generic versions is governed by ANDA submissions, which demonstrate pharmaceutical equivalence and bioequivalence to the reference listed drug. Biosimilar pathways, designed for large molecule biologics, are not applicable here.
• Interchangeability: While not explicitly termed "interchangeable" in the same way as biologics, generic metformin XR products approved by the FDA are considered therapeutically equivalent and can be substituted for the reference product (Glucophage XR) by pharmacists, subject to state laws and prescriber directions. This interchangeability is a core driver of generic market penetration and price competition.
• FDA Orange Book: The FDA's Orange Book lists approved drugs, including their patent and exclusivity information. It designates generics as "AB" rated, indicating they are bioequivalent and therapeutically equivalent to the reference product, reinforcing their interchangeable status in practice.

What are the Key Regulatory Considerations for Manufacturers and Marketers of NDC 00172-5728?

Manufacturers and marketers of NDC 00172-5728, both branded and generic, must navigate a stringent regulatory environment.

• FDA Oversight: The FDA is responsible for approving drug applications, ensuring manufacturing quality through Good Manufacturing Practices (GMP) inspections, and monitoring post-market safety via adverse event reporting systems.
• Labeling Requirements: All approved drug products, including generics, must adhere to FDA-approved labeling, which includes indications, contraindications, warnings, precautions, and dosage information. Any changes to labeling must be approved by the FDA.
• Manufacturing Compliance: Manufacturers must maintain facilities and processes that comply with GMP regulations to ensure product quality, purity, and potency. Failure to comply can result in warning letters, product recalls, and import alerts.
• Advertising and Promotion: Marketing and promotional activities are regulated by the FDA's Office of Prescription Drug Promotion (OPDP) to ensure that claims are truthful, not misleading, and consistent with the approved labeling.
• Drug Shortage Monitoring: The FDA monitors for potential drug shortages and works with manufacturers to mitigate supply disruptions. As a widely used medication, metformin XR is a critical drug where shortages can have significant public health implications.
• Pricing Regulations: While direct price controls are limited in the U.S. for pharmaceuticals, factors like Medicare/Medicaid rebate obligations and the increasing scrutiny of drug pricing by lawmakers and the public can indirectly influence pricing strategies.

Key Takeaways

• NDC 00172-5728, representing branded Glucophage XR, faces intense and persistent competition from numerous generic metformin hydrochloride extended-release formulations.
• The patent exclusivity for the original Glucophage XR formulation has expired, permitting widespread generic market entry.
• The primary price driver for NDC 00172-5728 is generic competition, which is projected to cause a steady decline in its average selling price over the next five years.
• Generic metformin XR products are considered therapeutically equivalent and interchangeable with the branded product, facilitating their widespread adoption.
• Manufacturers and marketers must adhere to strict FDA regulations concerning drug approval, manufacturing, labeling, and promotion.

Frequently Asked Questions

1. Will NDC 00172-5728 be discontinued? Discontinuation is unlikely in the short to medium term, given the continued demand for metformin as a first-line diabetes therapy. However, its market share will continue to diminish as generic alternatives capture more of the prescription volume.

2. What is the typical price difference between branded Glucophage XR and its generic equivalents? Generic metformin XR is typically priced 70-90% lower than the branded Glucophage XR, reflecting standard industry pricing dynamics for established generics.

3. Are there any new patent filings that could impact the market for NDC 00172-5728? Given the age of the original formulation, significant new patent filings that would provide substantial market exclusivity are improbable. Any new filings would likely pertain to minor formulation improvements or manufacturing processes, offering limited protection against existing generics.

4. How do payer formularies influence the price of NDC 00172-5728? Payer formularies heavily influence pricing. Drugs with preferred formulary status, particularly generics, achieve higher market penetration. The branded product will face pressure to align its price with or below generics to secure preferred formulary placement.

5. What impact will the development of novel diabetes medications have on metformin XR pricing? The introduction of new diabetes medications with novel mechanisms of action may gradually shift treatment paradigms, potentially reducing the overall volume demand for metformin XR over the long term. This could indirectly contribute to downward price pressure on all metformin XR products, including NDC 00172-5728.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ [2] Global Market Insights. (2023). Diabetes Market Analysis Report. [3] IQVIA. (2023). Global Pharmaceutical Market Trends. [4] U.S. Food and Drug Administration. (n.d.). Guidance for Industry and FDA Staff: ANDA Approvals for Generic Drugs.