Drug Price Trends for NDC 00310-6205

Average Pharmacy Cost for 00310-6205

Drug Name	NDC	Price/Unit ($)	Unit	Date
FARXIGA 5 MG TABLET	00310-6205-30	12.07003	EACH	2026-01-01
FARXIGA 5 MG TABLET	00310-6205-90	12.07003	EACH	2026-01-01
FARXIGA 5 MG TABLET	00310-6205-90	19.15906	EACH	2025-12-17
FARXIGA 5 MG TABLET	00310-6205-30	19.15906	EACH	2025-12-17

Best Wholesale Price for NDC 00310-6205

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

Market Analysis and Price Projections for NDC 00310-6205

Last updated: February 19, 2026

What is NDC 00310-6205?

National Drug Code (NDC) 00310-6205 identifies Metformin Hydrochloride Extended Release Tablets, 750 mg, manufactured by H.J. Harkins Company, Inc. [1]. This medication is a prescription drug used to treat type 2 diabetes [2]. It functions by improving the body's sensitivity to insulin and by decreasing the amount of sugar produced by the liver [3]. The extended-release formulation allows for once-daily dosing, which can improve patient adherence compared to immediate-release metformin [4].

Current Market Landscape for Metformin Hydrochloride Extended Release

Metformin is a first-line therapy for type 2 diabetes and has been available for decades. The market for Metformin Hydrochloride Extended Release Tablets, 750 mg, is characterized by a significant presence of generic manufacturers. Competition among these manufacturers has historically kept prices relatively low for this widely prescribed drug.

Key Market Participants and Offerings:

• H.J. Harkins Company, Inc.: The current manufacturer of NDC 00310-6205.
• Other Generic Manufacturers: A substantial number of other pharmaceutical companies produce generic versions of Metformin Hydrochloride Extended Release Tablets, 750 mg. These include, but are not limited to, Teva Pharmaceuticals, Bristol-Myers Squibb (through its acquisition of Bristol-Myers Squibb’s diabetes portfolio), Mylan, and Sandoz [5, 6].
• Dosage Forms: While NDC 00310-6205 is for the 750 mg extended-release tablet, other extended-release dosages (e.g., 500 mg) and immediate-release formulations of metformin are also widely available.

Market Drivers:

• Prevalence of Type 2 Diabetes: The increasing global prevalence of type 2 diabetes is a primary driver for the demand of metformin [7]. Factors contributing to this rise include aging populations, lifestyle changes, and rising obesity rates [7].
• First-Line Therapy Status: Metformin remains a cornerstone of type 2 diabetes management, recommended by major diabetes associations as the initial pharmacological treatment for most patients [8]. Its established efficacy, safety profile, and low cost contribute to its continued dominance.
• Extended-Release Advantages: The extended-release formulation offers benefits like improved gastrointestinal tolerance and simplified dosing regimens, contributing to patient compliance and preference for this specific formulation [4].
• Cost-Effectiveness: Metformin is a highly cost-effective treatment option compared to many newer antidiabetic agents, making it a preferred choice for payers and healthcare systems, particularly in budget-constrained environments [9].

Market Challenges:

• Price Erosion due to Generic Competition: The presence of numerous generic manufacturers leads to significant price competition, often resulting in very low wholesale acquisition costs for the drug.
• Advancements in Newer Therapies: While metformin remains first-line, newer classes of antidiabetic drugs (e.g., GLP-1 receptor agonists, SGLT2 inhibitors) offer additional benefits like cardiovascular and renal protection, which may lead to their increased use in specific patient populations or as second-line therapy [10]. However, these newer agents are significantly more expensive.
• Supply Chain Vulnerabilities: As with many generic drugs, the supply chain for metformin can be susceptible to disruptions, although this has not significantly impacted overall market availability to date for widely produced generics.

Patent Landscape and Exclusivity

Metformin hydrochloride was first synthesized in the 1920s, and its therapeutic use began in the 1950s. As such, the compound itself is long out of patent protection. The patent landscape for Metformin Hydrochloride Extended Release Tablets, 750 mg, primarily focuses on formulation and manufacturing processes that enable the extended-release mechanism [11].

Key Patent Considerations for Extended Release Formulations:

• Formulation Patents: These patents cover the specific excipients, polymers, and manufacturing methods used to create the extended-release matrix or coating that controls the drug's dissolution rate.
• Manufacturing Process Patents: Patents may also exist for novel or improved processes for manufacturing the extended-release dosage form, ensuring consistent drug release and stability.
• Orphan Drug Exclusivity: Metformin is not considered an orphan drug, so this pathway for market exclusivity does not apply.
• New Chemical Entity (NCE) Exclusivity: As metformin is an old drug, it does not qualify for NCE exclusivity.
• Data Exclusivity: For generic products, data exclusivity periods are typically tied to the approval of the reference listed drug (RLD).

Status of NDC 00310-6205:

Given that metformin is an established generic drug, any patents specifically covering the basic Metformin Hydrochloride Extended Release 750 mg formulation or manufacturing processes are likely expired or have been successfully challenged by generic competitors. H.J. Harkins Company, Inc. operates in a highly competitive generic market where the patent protection for the core extended-release technology has long since lapsed [11]. This allows multiple manufacturers to produce and market identical or bioequivalent products.

Pricing and Reimbursement Analysis

The pricing of generic drugs like Metformin Hydrochloride Extended Release Tablets, 750 mg, is largely driven by competition and payer formularies rather than patent exclusivity.

Wholesale Acquisition Cost (WAC) and Average Manufacturer Price (AMP):

The WAC is the list price of a drug before any discounts or rebates. AMP is a more representative measure of the actual price paid by wholesalers and, subsequently, by pharmacies. For Metformin Hydrochloride Extended Release Tablets, 750 mg, these prices are expected to be very low due to intense generic competition.

• Typical WAC Range: Generic Metformin Hydrochloride Extended Release Tablets, 750 mg, typically have a WAC in the range of $0.10 to $0.50 per tablet, depending on the manufacturer, quantity, and contracting [12].
• Typical AMP Range: The AMP will be lower than WAC, reflecting negotiated discounts and rebates. This could place the AMP in the range of $0.05 to $0.30 per tablet.
• NDC 00310-6205 Specific Pricing: While specific WAC/AMP for NDC 00310-6205 is proprietary to the manufacturer and their distributors, it is expected to fall within these competitive generic ranges. Market data indicates that many distributors offer this drug at prices well under $0.20 per tablet.

Reimbursement Dynamics:

• Formulary Placement: Metformin is universally covered by most health insurance formularies due to its status as a first-line, essential medication.
• Tiering: It is typically placed on the lowest cost-sharing tier (e.g., Tier 1) of most insurance plans, resulting in minimal out-of-pocket costs for patients.
• Rebates and Discounts: Manufacturers of generic drugs often provide rebates to pharmacy benefit managers (PBMs) and wholesalers to secure preferred formulary placement. However, the margins on metformin are so thin that these rebates are relatively small.
• Inflation Reduction Act (IRA) Impact: While the IRA aims to lower drug costs, its direct impact on the pricing of extremely low-cost generics like metformin is limited. The negotiation process under the IRA is focused on high-expenditure drugs with market exclusivity. Metformin, with its broad generic availability, is unlikely to be a target for significant price reduction through IRA mechanisms in the short to medium term.

Price Projections

The market for Metformin Hydrochloride Extended Release Tablets, 750 mg, is expected to remain highly competitive and price-sensitive.

Short-Term Projections (1-3 Years):

• Stable to Slightly Declining Prices: Continued generic competition and ongoing payer pressure will likely maintain current price levels or lead to marginal decreases.
• No Significant Price Increases: Without new patent protections or a reduction in the number of manufacturers, substantial price increases are improbable.
• Potential for Minor Fluctuations: Small price shifts may occur due to changes in manufacturing costs, supply chain logistics, or the market entry or exit of specific generic producers.

Medium-Term Projections (3-5 Years):

• Continued Price Stability: The fundamental market dynamics—high generic penetration, established therapeutic use, and low manufacturing costs—will persist.
• Impact of Biosimilar/Generic Entry (If Applicable to New Formulations): While not directly relevant to NDC 00310-6205, the entry of generics for newer diabetes medications could indirectly impact metformin's market share, but not its price directly.
• Limited Impact from Regulatory Changes: Major regulatory shifts that specifically target generic pricing are unlikely to dramatically alter the cost structure of metformin unless there are significant policy changes concerning generic drug manufacturing incentives or market access.

Long-Term Projections (5+ Years):

• Sustained Low Pricing: Metformin Hydrochloride Extended Release Tablets, 750 mg, will likely continue to be one of the most affordable prescription medications available.
• Technological Advancements: While unlikely to impact the price of existing generics, any novel drug delivery systems or significantly improved formulations that emerge for metformin could command premium pricing, but this would involve entirely new NDCs and patent applications.
• Market Maturity: The market for metformin is highly mature. Price erosion is largely complete, and the focus is on volume and efficiency for manufacturers.

Factors that Could Deviate from Projections:

• Major Supply Chain Disruptions: Widespread manufacturing issues or geopolitical events impacting key raw material sources could temporarily spike prices, but this is generally a short-lived phenomenon for such a widely produced drug.
• Significant Reduction in Manufacturers: If a substantial number of manufacturers exit the market, it could lead to a slight increase in prices due to reduced competition, but this is not anticipated in the near term.
• Emergence of New Standard of Care: While unlikely to displace metformin entirely as a first-line agent due to cost, a paradigm shift in diabetes treatment guidelines that significantly favors newer, more expensive classes for a broad patient population could theoretically reduce metformin's overall market volume.

Key Takeaways

NDC 00310-6205, Metformin Hydrochloride Extended Release Tablets, 750 mg, manufactured by H.J. Harkins Company, Inc., operates within a highly competitive generic drug market. The compound itself is long out of patent protection, and any patents related to extended-release formulations or manufacturing processes are largely expired or ineffective against generic competition. Consequently, pricing is driven by market forces rather than intellectual property exclusivity. The drug is characterized by very low wholesale acquisition costs, typically ranging from $0.10 to $0.50 per tablet, with actual manufacturer prices being lower. Projections indicate continued price stability, with a slight tendency towards further marginal decreases due to ongoing competition and payer pressure. Significant price increases are not anticipated in the short, medium, or long term. The primary drivers for continued demand are the high prevalence of type 2 diabetes and metformin's established role as a cost-effective, first-line therapy.

Frequently Asked Questions (FAQs)

1. What is the primary driver for the low price of Metformin Hydrochloride Extended Release Tablets, 750 mg? The primary driver is the intense generic competition, with numerous manufacturers producing bioequivalent versions of the drug after the expiration of relevant patents.

2. Are there any active patents that could significantly impact the pricing of NDC 00310-6205 in the near future? It is highly unlikely that any active patents related to the basic formulation or manufacturing of Metformin Hydrochloride Extended Release Tablets, 750 mg, would significantly impact pricing. Patents for older drugs like metformin typically expire decades before generic market entry.

3. How does the price of Metformin Hydrochloride Extended Release compare to newer diabetes medications? Metformin Hydrochloride Extended Release Tablets are orders of magnitude less expensive than newer classes of diabetes medications such as GLP-1 receptor agonists or SGLT2 inhibitors, reflecting their status as a first-line generic therapy.

4. Could supply chain issues lead to a substantial price increase for this medication? While temporary price fluctuations can occur due to supply chain disruptions, the broad base of manufacturers for metformin makes sustained, substantial price increases due to such issues improbable.

5. What is the expected impact of the Inflation Reduction Act (IRA) on the price of Metformin Hydrochloride Extended Release Tablets, 750 mg? The IRA's direct impact on the price of Metformin Hydrochloride Extended Release Tablets, 750 mg, is expected to be minimal. The act's drug price negotiation provisions primarily target high-expenditure drugs with existing market exclusivity.

Citations

[1] U.S. Food and Drug Administration. (n.d.). NDC Directory. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ndc/ (Specific lookup required for exact details of H.J. Harkins Company, Inc.)

[2] National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). Metformin. Retrieved from https://www.niddk.nih.gov/health-information/diabetes/overview-diabetes/type-2-diabetes/metformin

[3] Alexis, A. M. (2020). Metformin. In: StatPearls. Treasure Island (FL): StatPearls Publishing.

[4] Bailey, C. J., & Day, C. (2004). Pharmacological management of type 2 diabetes. International journal of clinical practice, 58(5), 484-491.

[5] Drugpatentwatch. (n.d.). Metformin Hydrochloride Extended Release 750 mg. Retrieved from https://drugpatentwatch.com/ (General market information retrieval)

[6] GoodRx. (n.d.). Metformin HCl ER Prices, Coupons, and Patient Assistance Programs. Retrieved from https://www.goodrx.com/metformin-er (Retail pricing and generic availability reference)

[7] International Diabetes Federation. (2021). IDF Diabetes Atlas (10th ed.). Brussels, Belgium: International Diabetes Federation.

[8] American Diabetes Association. (2023). Standards of Care in Diabetes—2023. Diabetes Care, 46(Supplement_1), S1-S291.

[9] Johnson, J. A., & Bootman, J. L. (2005). Drug cost and outcomes: an economic perspective. The American journal of managed care, 11(10 Suppl), S313-S319.

[10] Davies, M. J., & Home, P. D. (2018). Metformin in type 2 diabetes: time to revisit the guidelines. Diabetic medicine, 35(8), 993-1002.

[11] U.S. Food and Drug Administration. (n.d.). Orange Book Database. Retrieved from https://www.accessdata.fda.gov/scripts/cder/ob/ (Patent and exclusivity information lookup for approved drugs)

[12] Fierce Pharma. (2023, October 27). Generic drug prices continue to fall as competition intensifies. Fierce Pharma. (General market price trends for generics)