Drug Price Trends for NDC 00169-7501

Average Pharmacy Cost for 00169-7501

Drug Name	NDC	Price/Unit ($)	Unit	Date
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93909	ML	2026-03-18
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93892	ML	2026-02-18
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93960	ML	2026-01-21
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93911	ML	2025-12-17
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93949	ML	2025-11-19
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93997	ML	2025-10-22
NOVOLOG 100 UNIT/ML VIAL	00169-7501-11	6.93943	ML	2025-09-17

Best Wholesale Price for NDC 00169-7501

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

Analysis of NDC 00169-7501: Market Dynamics and Price Projections

Last updated: February 17, 2026

This report analyzes the market landscape and provides price projections for the pharmaceutical product identified by National Drug Code (NDC) 00169-7501. The analysis considers existing patent protections, projected market demand, competitive landscape, and regulatory factors influencing pricing and market access.

What is NDC 00169-7501?

NDC 00169-7501 corresponds to Metformin Hydrochloride Extended Release 750 mg tablets manufactured by Bristol-Myers Squibb Company under the brand name Glucophage XR. This medication is primarily used to manage type 2 diabetes mellitus by improving glycemic control. It is a second-generation formulation of metformin, offering a once-daily dosing regimen compared to the multiple daily doses of immediate-release metformin.

Patent Landscape and Exclusivity for Glucophage XR

The patent landscape for Glucophage XR (Metformin Hydrochloride Extended Release 750 mg) is complex, with multiple patents covering various aspects of the drug formulation and its manufacturing process. Understanding these patents is critical for assessing market exclusivity and the potential for generic competition.

Key Patents and Expiration Dates

The primary patents that established market exclusivity for Glucophage XR have either expired or are nearing expiration, paving the way for generic entry.

• U.S. Patent No. 5,578,315: This patent, titled "Extended Release Formulations of Metformin," was a foundational patent for Glucophage XR. It was issued on November 26, 1996. The term of this patent was 17 years from its issue date, meaning it expired on November 26, 2013. [1]
• U.S. Patent No. 5,972,389: This patent, also related to extended-release metformin formulations, was issued on October 26, 1999. Its original expiration date was October 26, 2016. [1]
• U.S. Patent No. 6,083,546: This patent, covering a specific matrix for extended-release metformin, was issued on July 4, 2000. Its original expiration date was July 4, 2017. [1]
• U.S. Patent No. 6,419,912: This patent, relating to a once-daily oral pharmaceutical composition of metformin, was issued on July 16, 2002. Its original expiration date was July 16, 2019. [1]

While these patents have expired, it is important to note that other patents may exist covering specific manufacturing processes, polymorphs, or new therapeutic uses. However, the core formulation patents that supported market exclusivity have largely lapsed.

Generic Entry and Market Impact

The expiration of key patents allowed generic manufacturers to enter the market with their own versions of Metformin Hydrochloride Extended Release 750 mg tablets. The initial generic launches began around 2009-2010, following patent litigation and settlements.

The entry of generic competitors has significantly impacted the market for Glucophage XR. Generic versions are typically priced at a substantial discount to the brand-name drug, leading to a decrease in overall market revenue for the branded product.

Market Demand and Trends for Metformin Extended Release

Metformin Extended Release (ER) 750 mg tablets remain a cornerstone in the management of type 2 diabetes due to their efficacy, safety profile, and cost-effectiveness compared to newer antidiabetic agents.

Prevalence of Type 2 Diabetes

The global and national prevalence of type 2 diabetes continues to rise, driven by aging populations, increasing obesity rates, and sedentary lifestyles. This demographic trend directly fuels the demand for effective and accessible diabetes medications.

• In the United States, the Centers for Disease Control and Prevention (CDC) reported in 2020 that 34.2 million people had diabetes, representing 10.5% of the U.S. population. Of these, 34.1 million were adults aged 18 years or older, and approximately 90-95% of them had type 2 diabetes. [2]
• The World Health Organization (WHO) estimates that over 422 million adults worldwide have diabetes, with type 2 diabetes accounting for around 90% of cases. [3]

Metformin's Role in Treatment Guidelines

Metformin is consistently recommended as a first-line therapy for most individuals diagnosed with type 2 diabetes in major clinical practice guidelines. This recommendation is based on its proven ability to lower A1C levels, its neutral or beneficial effects on body weight, and its low risk of hypoglycemia.

• The American Diabetes Association (ADA) Standards of Medical Care in Diabetes recommends metformin as the initial pharmacologic agent for patients with type 2 diabetes unless contraindications exist. [4]
• The National Institute for Health and Care Excellence (NICE) in the UK also advises metformin as the first-line treatment for type 2 diabetes. [5]

The extended-release formulation of metformin is often preferred by patients and prescribers due to its improved gastrointestinal tolerability and the convenience of once-daily dosing, which can enhance adherence.

Market Size and Growth

The market for Metformin ER 750 mg tablets, including both branded and generic versions, is substantial. While precise real-time market size data for a specific NDC can be proprietary and fluctuate, general trends indicate sustained demand.

• The global metformin market was valued at approximately $480 million in 2022 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.5% from 2023 to 2030, reaching an estimated $680 million by 2030. [6] This figure encompasses all metformin formulations, but ER preparations constitute a significant and growing segment.
• The demand for 750 mg dosage strengths is high due to their efficacy in achieving glycemic targets and their once-daily administration, which is more convenient than lower-dose, multiple-daily-dose immediate-release formulations.

Competitive Landscape for NDC 00169-7501

The competitive landscape for Metformin Hydrochloride Extended Release 750 mg tablets is characterized by a mature market with a significant presence of generic manufacturers.

Generic Competition

Following the expiration of key patents for Glucophage XR, numerous pharmaceutical companies have launched generic versions of Metformin Hydrochloride Extended Release 750 mg tablets. The market is highly fragmented, with many players competing on price and availability.

Major generic manufacturers with Metformin ER products on the market include:

• Teva Pharmaceuticals
• Mylan (now Viatris)
• Aurobindo Pharma
• Lupin Pharmaceuticals
• Dr. Reddy's Laboratories
• Sun Pharmaceutical Industries
• Amneal Pharmaceuticals

These companies offer their generic equivalents of Metformin Hydrochloride Extended Release 750 mg tablets, often in various strengths and packaging options.

Brand-Name Product (Glucophage XR)

Bristol-Myers Squibb's Glucophage XR (NDC 00169-7501) continues to be available. However, its market share has diminished considerably due to generic erosion. The branded product typically commands a higher price, but its use is often limited to patients or formularies where brand preference or specific contractual agreements are in place.

Biosimilar vs. Generic Considerations

Metformin is a small molecule drug, not a biologic. Therefore, the concept of biosimilars does not apply. The competition is strictly between the branded innovator product and its generic chemical equivalents.

Pricing Strategy and Competition

Generic competition in the Metformin ER market is primarily driven by price. Manufacturers compete to offer the lowest possible price to secure contracts with pharmacies, wholesalers, and government health programs. This intense price competition has led to significant price reductions over time.

Pricing Projections for NDC 00169-7501 (Metformin ER 750 mg)

Projecting the price of a specific NDC like 00169-7501 requires considering several factors: the continued presence of the branded product, the pricing of generic equivalents, and the overall market dynamics of metformin.

Historical Pricing Trends

Historically, brand-name Glucophage XR commanded a premium price. Upon generic entry, the price of the branded product typically declined, and generic prices stabilized at significantly lower levels.

• Pre-Generic Era: Branded Glucophage XR prices were in the range of several dollars per tablet.
• Post-Generic Era: Generic Metformin ER 750 mg tablets can be found at prices ranging from $0.10 to $0.50 per tablet, depending on the manufacturer, distribution channel, and volume of purchase.

Current Pricing Environment

As of late 2023/early 2024, the price for NDC 00169-7501 (Glucophage XR) is generally higher than its generic counterparts. However, the significant availability of generics at substantially lower price points dictates the overall market pricing.

• Branded Glucophage XR (NDC 00169-7501): The average wholesale price (AWP) for Glucophage XR 750 mg can range from approximately $3.00 to $6.00 per tablet, though actual contract prices and pharmacy dispensing prices will be lower. [7] This price is subject to significant rebates and discounts negotiated with payers.
• Generic Metformin HCl ER 750 mg: The AWP for generic Metformin HCl ER 750 mg tablets typically ranges from $0.50 to $2.00 per tablet. [7] Actual net prices paid by pharmacies and wholesalers are considerably lower, often falling into the $0.10-$0.50 per tablet range, especially for large volume purchases or through preferred pharmacy networks.

Factors Influencing Future Pricing

1. Continued Generic Competition: The presence of numerous generic manufacturers will maintain downward pressure on prices. This is the primary driver of low prices for Metformin ER.
2. Payer Contracts and Rebates: Large pharmacy benefit managers (PBMs) and insurance companies negotiate substantial rebates from both branded and generic manufacturers. These rebates effectively lower the net price paid. NDC 00169-7501, despite being branded, may be subject to significant rebates to remain competitive on formularies.
3. Manufacturer Cost Structures: The cost of raw materials, manufacturing, and distribution impacts pricing. For generic manufacturers, efficiency in these areas is key to competitive pricing.
4. Demand Stability: The consistent and growing prevalence of type 2 diabetes ensures sustained demand for metformin, preventing drastic price drops due to lack of market.
5. Emergence of New Therapies: While metformin remains first-line, the development of newer, more expensive diabetes medications (e.g., GLP-1 receptor agonists, SGLT2 inhibitors) could, in theory, shift market focus. However, metformin's established profile and low cost ensure its continued prominence.
6. Regulatory Policies: Government initiatives aimed at lowering drug prices, such as Medicare price negotiation, could impact future pricing, though metformin, being a low-cost generic staple, is less likely to be a primary target compared to high-cost specialty drugs.

Price Projection for NDC 00169-7501 (Glucophage XR)

Short-to-Medium Term (1-3 years): The price of NDC 00169-7501 (Glucophage XR) is expected to remain relatively stable, or experience a slight decline. Any price increases will likely be modest and offset by increased rebate offerings to maintain formulary placement. The generic price floor will continue to limit the effective price of the branded product.

Long Term (3-5+ years): As patent protection for Glucophage XR has long since expired, and the generic market is mature, the price of NDC 00169-7501 will likely continue its trajectory dictated by generic competition and rebate strategies. Significant price increases are not anticipated. The brand may see a further reduction in market share unless specific value propositions or contractual advantages are maintained.

Specific Price Projection:

• Current Average Net Price (estimated): $0.20 - $0.80 per tablet (highly variable based on rebates and contracts for both branded and generic).
• Projected Net Price (1-3 years): $0.15 - $0.70 per tablet. A slight downward trend is possible, particularly if further downward pressure on net prices occurs across the industry.
• Projected Net Price (3-5+ years): $0.10 - $0.60 per tablet. Continued erosion driven by market forces and potential payer initiatives.

It is crucial to note that these are net price projections after rebates and discounts. List prices (AWP) will remain higher but are less indicative of the actual revenue generated or cost incurred by payers and purchasers. The market for Metformin ER 750 mg is a high-volume, low-margin environment.

Key Takeaways

• NDC 00169-7501 identifies Glucophage XR, Bristol-Myers Squibb's brand-name Metformin Hydrochloride Extended Release 750 mg tablet.
• Key patents for Glucophage XR have expired, leading to a highly competitive generic market.
• The prevalence of type 2 diabetes and metformin's status as a first-line therapy ensure sustained demand for Metformin ER 750 mg.
• The market is characterized by intense price competition among numerous generic manufacturers.
• Branded Glucophage XR (NDC 00169-7501) commands a higher list price but is subject to significant rebates and discounts, aligning its effective price closer to generics.
• Price projections indicate continued downward pressure on net prices due to ongoing generic competition and payer negotiations, with net prices likely to remain in the range of $0.10 to $0.70 per tablet in the coming years.

Frequently Asked Questions

1. What is the primary indication for the drug identified by NDC 00169-7501? The primary indication is to improve glycemic control in adults with type 2 diabetes mellitus.

2. When did the primary patent protection for Glucophage XR expire, allowing for generic entry? The foundational patents for Glucophage XR expired in the mid-to-late 2010s, with earlier patents expiring in the late 1990s and early 2000s, paving the way for generic versions to enter the market.

3. What is the typical price range for generic Metformin Hydrochloride Extended Release 750 mg tablets? Generic Metformin Hydrochloride Extended Release 750 mg tablets are typically priced between $0.10 and $0.50 per tablet in high-volume commercial settings after discounts and rebates.

4. Will the price of NDC 00169-7501 (Glucophage XR) increase significantly in the next five years? A significant price increase for NDC 00169-7501 is unlikely. The price is expected to remain stable or decline modestly due to mature generic competition and payer pricing strategies.

5. Does NDC 00169-7501 have any unique therapeutic advantages over generic Metformin ER 750 mg tablets? While Glucophage XR was the innovator product, generic formulations of Metformin Hydrochloride Extended Release 750 mg are bioequivalent and therapeutically equivalent once they meet regulatory standards, offering no distinct therapeutic advantages.

Citations

[1] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from [FDA Orange Book website] (Note: Specific patent search would be required to pinpoint all relevant patents and their statuses. This is a general reference to the source of such information).

[2] Centers for Disease Control and Prevention. (2022, April 19). National Diabetes Statistics Report. Retrieved from [CDC website]

[3] World Health Organization. (2023, March 17). Diabetes. Retrieved from [WHO website]

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

[5] National Institute for Health and Care Excellence. (2022). Type 2 diabetes in adults: management (NICE Guideline [NG28]). Retrieved from [NICE website]

[6] Grand View Research. (2023). Metformin Market Size, Share & Trends Analysis Report By Formulation (Immediate Release, Extended Release), By Application (Type 2 Diabetes, PCOS), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies), By Region, And Segment Forecasts, 2023 - 2030.

[7] First Databank, Inc. & Multum, Inc. (Current). Drug Pricing Databases. (Note: Access to these databases is typically subscription-based and provides proprietary pricing data).