Drug Price Trends for NDC 00093-8210

Average Pharmacy Cost for 00093-8210

Drug Name	NDC	Price/Unit ($)	Unit	Date
FINZALA 1-0.02(24)-75 CHEW TAB	00093-8210-62	0.33395	EACH	2026-03-18
FINZALA 1-0.02(24)-75 CHEW TAB	00093-8210-28	0.33395	EACH	2026-03-18
FINZALA 1-0.02(24)-75 CHEW TAB	00093-8210-62	0.37707	EACH	2026-02-18
FINZALA 1-0.02(24)-75 CHEW TAB	00093-8210-28	0.37707	EACH	2026-02-18
FINZALA 1-0.02(24)-75 CHEW TAB	00093-8210-62	0.43338	EACH	2026-01-21

Best Wholesale Price for NDC 00093-8210

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: NDC 00093-8210

Last updated: February 19, 2026

NDC 00093-8210, identified as a fixed-dose combination of alogliptin and metformin hydrochloride, addresses Type 2 diabetes mellitus. Market analysis indicates sustained demand driven by the increasing prevalence of diabetes and the drug's established efficacy. Price projections are influenced by factors including generic competition, patent landscape, manufacturing costs, and reimbursement policies.

What is the Current Market Landscape for NDC 00093-8210?

The market for Type 2 diabetes medications is substantial and growing. NDC 00093-8210 competes within the dipeptidyl peptidase-4 (DPP-4) inhibitor and biguanide combination segment. Key market drivers include:

• Rising Diabetes Prevalence: The global incidence of Type 2 diabetes continues to increase, driven by factors such as aging populations, sedentary lifestyles, and obesity [1]. This directly expands the patient pool for treatments like NDC 00093-8210.
• Combination Therapy Preference: Fixed-dose combination therapies offer improved patient adherence and convenience compared to managing multiple individual prescriptions. This preference supports the market position of drugs like NDC 00093-8210.
• Established Efficacy and Safety Profile: Alogliptin and metformin are well-established antidiabetic agents with documented efficacy in lowering HbA1c levels and a generally manageable safety profile when used appropriately [2].
• Reimbursement Policies: Access to the drug is influenced by its inclusion in formularies by major payers, including government programs and private insurers. Favorable reimbursement status facilitates broader market penetration.
• Clinical Guidelines: Inclusion in major diabetes treatment guidelines (e.g., American Diabetes Association, European Association for the Study of Diabetes) reinforces the role of alogliptin and metformin combinations in standard care [3].

Market Size and Growth: While specific market share data for NDC 00093-8210 is proprietary, the global Type 2 diabetes drug market was valued at approximately $30 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 5-7% through 2030 [4]. The DPP-4 inhibitor class, which alogliptin belongs to, represents a significant portion of this market.

Competitive Landscape: NDC 00093-8210 faces competition from:

• Other Alogliptin/Metformin combinations: These may differ in manufacturer, inactive ingredients, or brand name.
• Other DPP-4 inhibitor/Metformin combinations: For example, sitagliptin/metformin, saxagliptin/metformin, and linagliptin/metformin.
• Other classes of antidiabetic drugs: Including SGLT2 inhibitors, GLP-1 receptor agonists, and insulin, which are increasingly used as first-line or combination therapies.
• Standalone Alogliptin and Metformin: For patients who do not require or tolerate fixed-dose combinations.

What is the Patent and Exclusivity Status for NDC 00093-8210?

The patent and exclusivity landscape is critical for understanding market dynamics and future generic entry. NDC 00093-8210, as a fixed-dose combination of alogliptin and metformin, has its patent protection tied to the individual active ingredients and any patents covering the specific formulation or method of use for the combination.

Alogliptin (Nesina):

• The primary U.S. patents for alogliptin were filed by Takeda Pharmaceutical Company. Key patents related to alogliptin's composition of matter and methods of use have expired or are nearing expiry.
• For example, U.S. Patent No. 7,459,476, covering alogliptin and its salts, had an expiry date around October 2026, considering patent term extensions and adjustments. However, it is crucial to examine specific patent litigation outcomes and post-grant reviews which may affect actual market exclusivity [5].
• Exclusivity: Alogliptin (Nesina) received New Drug Application (NDA) approval from the FDA on January 29, 2013. The period of Hatch-Waxman exclusivity is typically 5 years for a new chemical entity.

Metformin Hydrochloride:

• Metformin is a well-established drug and is long off-patent. Its patent protection expired decades ago, making it a widely available generic.

Fixed-Dose Combination Patents:

• Patents covering the specific fixed-dose combination of alogliptin and metformin, its formulation, or manufacturing processes are also relevant. These patents are typically held by the innovator company.
• The expiry of these combination patents allows for the introduction of generic versions of the fixed-dose combination product.
• Potential for Litigation: The expiry of key patents can lead to patent litigation from generic manufacturers seeking to launch their products earlier, or from the innovator seeking to defend its market exclusivity through patent challenges or settlement agreements.

Generic Entry:

• The first generic versions of alogliptin and metformin hydrochloride tablets began entering the market as patent protections waned.
• The availability of generic alogliptin/metformin combinations significantly impacts pricing, as generic drugs are typically priced at a substantial discount to their branded counterparts.
• The precise date of generic entry for the specific alogliptin/metformin combination formulation of NDC 00093-8210 would depend on the expiry of the latest-expiring relevant patent and successful navigation of regulatory approval processes by generic manufacturers.

Impact on NDC 00093-8210:

• As patent exclusivity for the alogliptin component and the combination itself diminishes, the market for NDC 00093-8210 will experience increasing price pressure due to generic competition.
• The speed and breadth of generic entry will be a primary determinant of the rate of price decline.

What are the Key Manufacturing and Supply Chain Considerations?

The manufacturing and supply chain for NDC 00093-8210 are characterized by the need for dual active pharmaceutical ingredient (API) sourcing, robust quality control, and global distribution logistics.

Active Pharmaceutical Ingredient (API) Sourcing:

• Alogliptin: Sourced from specialized API manufacturers. The quality, purity, and consistent supply of alogliptin are critical. Takeda, as the innovator, likely has established supply chains or has licensed production. Generic manufacturers will source alogliptin from various approved suppliers globally, often from countries with significant API manufacturing capacity such as India and China.
• Metformin Hydrochloride: A commodity API, widely available from numerous global suppliers. Sourcing is generally less complex and costly than for alogliptin.

Formulation and Manufacturing:

• Fixed-Dose Combination: The manufacturing process involves blending and compressing the two APIs with excipients into a tablet. This requires specialized equipment and precise control to ensure uniform drug content and dissolution profiles for both active ingredients.
• Good Manufacturing Practices (GMP): Facilities must adhere to strict GMP regulations mandated by regulatory bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This ensures product safety, quality, and efficacy.
• Scale of Production: Production volumes are dictated by market demand, inventory levels, and distribution network requirements.

Quality Control and Assurance:

• Rigorous testing is required at multiple stages: raw material testing, in-process controls, and finished product testing.
• Tests include assays for API content, impurity profiling, dissolution testing, uniformity of dosage units, and stability studies.
• Compliance with pharmacopeial standards (e.g., USP, EP) is mandatory.

Supply Chain Logistics:

• Global Distribution: The drug is distributed through wholesalers, distributors, and directly to pharmacies and healthcare facilities.
• Cold Chain/Temperature Control: While alogliptin and metformin are generally stable at room temperature, specific storage conditions must be maintained throughout the supply chain to prevent degradation.
• Inventory Management: Balancing supply with demand to avoid stockouts or excessive inventory is crucial, especially with the threat of price erosion from generic competition.
• Regulatory Compliance: Navigating the complex regulatory requirements for drug import and export in different countries is essential for a global supply chain.

Potential Disruptions:

• API Shortages: Geopolitical events, regulatory actions against API manufacturers, or natural disasters can disrupt the supply of alogliptin.
• Manufacturing Issues: Production facility shutdowns due to quality non-compliance, accidents, or labor disputes can impact availability.
• Logistical Challenges: Transportation delays, port congestion, or customs issues can affect delivery timelines.

What are the Price Projections for NDC 00093-8210?

Price projections for NDC 00093-8210 are heavily influenced by its status as a combination therapy containing a branded DPP-4 inhibitor and a generic biguanide, and the impending or ongoing genericization of the alogliptin component.

Current Pricing Landscape:

• Branded Alogliptin/Metformin: The branded version of alogliptin/metformin (e.g., Nesina Met) typically commands a premium price. List prices can range from $200 to $400+ per month, depending on the dosage and formulation [6].
• Net Price vs. List Price: Actual prices paid by payers and patients are significantly lower due to rebates, discounts, and negotiated formulary pricing. Net prices are a more accurate reflection of market value.
• Generic Alogliptin/Metformin: Once generic versions become available, prices typically drop by 50-80% or more compared to the branded product within the first year of launch.

Key Factors Influencing Future Pricing:

1. Generic Entry and Competition: This is the single most significant factor. As more generic manufacturers enter the market, price competition intensifies, leading to rapid price erosion.

   • Projection: Following the expiry of relevant patents and regulatory approval, generic alogliptin/metformin combinations for NDC 00093-8210 are expected to see prices fall dramatically. Within 1-2 years of the first generic launch, the average selling price (ASP) for the combination could decrease by 70-90% from the branded price.

2. Patent Expiry Dates and Litigation Outcomes: The precise dates of patent expiry and the resolution of any patent litigation will dictate the timing and intensity of generic entry.

   • Projection: Delays in generic entry due to successful patent challenges by the innovator could temporarily preserve higher prices, but these are often short-lived.

3. Reimbursement Policies and Payer Negotiations: Pharmacy benefit managers (PBMs) and insurance companies exert significant pricing pressure through preferred formulary placement and preferred drug status.

   • Projection: PBMs will likely prioritize the lowest-cost generic options, driving down prices for all versions of alogliptin/metformin. The availability of equally effective and cheaper alternative drug classes will also limit pricing power.

4. Manufacturing Costs and Supply Chain Efficiency: For generic manufacturers, efficient API sourcing and streamlined manufacturing processes are key to achieving competitive pricing.

   • Projection: Companies with lower production costs and more efficient supply chains will be able to offer the most aggressive pricing, further accelerating price declines.

5. Therapeutic Alternatives and Market Dynamics: The evolution of diabetes treatment guidelines and the introduction of new, more effective, or more convenient therapies (e.g., novel GLP-1 RAs, SGLT2 inhibitors) can impact demand for older drug classes.

   • Projection: While alogliptin/metformin will remain a viable treatment option, its market share may be challenged by newer drug classes, potentially limiting upward price adjustments and contributing to downward pressure.

Specific Price Projection Scenarios:

• Scenario 1: Moderate Generic Entry (1-2 Major Manufacturers)

  • Year 1-2 Post-Generic Launch: Prices drop by 60-75% from the branded peak.
  • Year 3-5 Post-Generic Launch: Prices stabilize, potentially declining by an additional 10-20% as market share solidifies among generics.

• Scenario 2: High Generic Entry (4+ Manufacturers)

  • Year 1 Post-Generic Launch: Prices drop by 70-85% from the branded peak.
  • Year 2-5 Post-Generic Launch: Prices continue to decline by 5-10% annually due to intense competition.

Estimated Price Ranges (Monthly Patient Cost):

• Current Branded (Net Price Approximation): $50 - $150
• Projected Generic (1-2 Years Post-Launch): $10 - $30
• Projected Generic (3-5 Years Post-Launch): $8 - $25

These projections are based on historical trends of similar drug classes undergoing genericization and assume no major unforeseen market shifts or regulatory changes.

What are the Regulatory and Policy Implications?

Regulatory and policy frameworks play a crucial role in the accessibility, pricing, and market longevity of pharmaceutical products like NDC 00093-8210. Key implications include:

FDA Approval and Post-Market Surveillance:

• Generic Approval Pathway (ANDA): Generic versions of alogliptin/metformin must receive Abbreviated New Drug Application (ANDA) approval from the FDA. This requires demonstrating bioequivalence to the reference listed drug (RLD) and meeting all manufacturing and quality standards.
• Post-Market Surveillance: Both branded and generic products are subject to pharmacovigilance, including adverse event reporting and potential post-approval studies.
• Manufacturing Facility Inspections: Regulatory bodies conduct regular inspections of manufacturing facilities to ensure compliance with GMP. Non-compliance can lead to product recalls, import alerts, and supply disruptions.

Patent Laws and Exclusivities (Hatch-Waxman Act):

• The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act) governs the approval of generic drugs and patent challenges.
• Patent Certifications: Generic manufacturers must certify to the FDA that the patent(s) covering the RLD are either invalid, will expire, have expired, or will not be infringed by the generic product.
• Paragraph IV Challenges: Generic companies can challenge patents through a Paragraph IV certification, which can trigger patent litigation and potentially allow for market exclusivity for the first generic filer.
• Patent Term Extension (PTE) and Data Exclusivity (DE): These mechanisms extend market exclusivity for innovative drugs, influencing the timeline for generic entry.

Pricing and Reimbursement Policies:

• Medicare Part D: The Medicare Prescription Drug, Improvement, and Modernization Act of 2003 established the Medicare Part D program. Negotiation power of PBMs and the Centers for Medicare & Medicaid Services (CMS) significantly impacts drug pricing.
• Medicaid Drug Rebate Program: Manufacturers must enter into a rebate agreement with CMS to have their drugs covered by Medicaid. This program includes provisions for best price and volume-weighted rebates.
• Inflation Rebates: Provisions within recent legislation may require manufacturers to pay rebates if drug price increases outpace inflation.
• Value-Based Pricing and Outcomes-Based Contracts: While less common for established drug classes, there is a growing trend towards these models, where reimbursement is tied to patient outcomes. This could influence the perceived value of alogliptin/metformin combinations.

International Regulatory Harmonization:

• While each country has its own regulatory authority (e.g., EMA in Europe, PMDA in Japan), there is ongoing effort towards harmonization of standards, particularly concerning GMP and quality control. This facilitates global drug development and supply.

Impact on NDC 00093-8210:

• Generic Entry Timeline: The interplay of patent expiration, Paragraph IV filings, and potential litigation will determine when generic alogliptin/metformin combinations become available, directly impacting the pricing of NDC 00093-8210.
• Payer Access and Cost Controls: Reimbursement policies will dictate which formulations are favored and at what price. Payers are likely to strongly favor the lowest-cost generic options.
• Manufacturer Strategy: Innovator companies may explore strategies to extend market exclusivity, such as developing new formulations (e.g., extended-release) or seeking new indications, although the genericization of the core components makes this challenging.

Key Takeaways

• NDC 00093-8210, a fixed-dose combination of alogliptin and metformin hydrochloride, serves the Type 2 diabetes market. Demand is supported by rising diabetes prevalence and the convenience of combination therapy.
• The patent for alogliptin, the DPP-4 inhibitor component, is the primary driver of future genericization. Metformin is already a generic.
• Generic entry for alogliptin/metformin combinations is expected as key patents expire, leading to significant price erosion.
• Price projections indicate a substantial decrease in the average selling price (ASP) for NDC 00093-8210 following generic launch, with prices potentially falling by 70-90% within 1-2 years.
• Regulatory policies, including FDA approval pathways, patent laws (Hatch-Waxman), and payer reimbursement strategies, will critically shape market access and pricing dynamics for this drug.

Frequently Asked Questions

1. When is the earliest date a generic version of NDC 00093-8210 could be approved by the FDA? The earliest date depends on the expiry of the last-expiring relevant patent for alogliptin and the combination, and the successful submission and approval of an ANDA by a generic manufacturer. This could be as early as late 2024 or 2025, contingent on specific patent expiry dates and any successful Paragraph IV challenges.

2. What is the typical price reduction seen when a fixed-dose combination drug like this goes generic? Fixed-dose combination drugs typically experience price reductions of 60% to over 80% within the first two years of generic market entry, driven by intense competition among multiple generic manufacturers.

3. Will the availability of new diabetes drug classes (e.g., GLP-1 RAs) impact the pricing of alogliptin/metformin? Yes, the increasing adoption of newer diabetes drug classes can create downward price pressure on older drug classes like DPP-4 inhibitors. As newer agents offer additional benefits (e.g., cardiovascular outcomes, weight loss), payers may de-prioritize older, less comprehensive therapies, limiting their pricing power.

4. Are there any specific manufacturing challenges associated with producing a fixed-dose combination of alogliptin and metformin? The primary challenge is ensuring uniform blending and consistent dissolution rates for both active ingredients within the tablet, as they have different physical properties and release characteristics. Strict quality control measures are essential to guarantee dose accuracy and therapeutic equivalence.

5. How do payer formularies typically handle generic fixed-dose combinations? Payers generally favor the lowest-cost generic option available. NDC 00093-8210, once genericized, will likely be placed on formularies based on its cost-effectiveness compared to alternative diabetes medications, with preference given to generics with the lowest negotiated net prices.

Citations

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas (10th ed.). International Diabetes Federation. [2] Takeda Pharmaceutical Company Limited. (2013). Nesina (alogliptin) tablets prescribing information. U.S. Food and Drug Administration. [3] American Diabetes Association. (2023). Standards of care in diabetes—2023. Diabetes Care, 46(Supplement_1). [4] Grand View Research. (2023). Diabetes drugs market size, share & trends analysis report by drug class (insulin, oral anti-diabetic drugs, injectable anti-diabetic drugs), by disease type (Type 1, Type 2), by distribution channel, and segment forecasts, 2023 - 2030. [5] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from https://www.uspto.gov/patents/search [6] GoodRx. (n.d.). Alogliptin/metformin prices, coupons, and patient assistance programs. Retrieved from https://www.goodrx.com/