Drug Price Trends for NDC 00597-0053

Average Pharmacy Cost for 00597-0053

Drug Name	NDC	Price/Unit ($)	Unit	Date

Best Wholesale Price for NDC 00597-0053

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
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	996.38		2022-09-15 - 2027-09-14	FSS
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	996.38		2023-01-01 - 2027-09-14	Big4
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	996.38		2023-01-01 - 2027-09-14	FSS
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	705.63		2024-01-01 - 2027-09-14	Big4
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	996.38		2024-01-01 - 2027-09-14	FSS
GLUCAGON	Boehringer Ingelheim Pharmaceuticals, Inc.	00597-0053-45	10X1ML	904.66		2022-09-15 - 2027-09-14	Big4

Analysis of Loratadine 10mg Oral Tablet (NDC: 00597-0053) Market and Price Projections

Last updated: February 17, 2026

This analysis examines the market landscape and projects future pricing for Loratadine 10mg oral tablets, identified by National Drug Code (NDC) 00597-0053. The current market is characterized by high generic penetration, a stable demand driven by allergy sufferers, and increasing competition from both established and emerging generic manufacturers. Price projections indicate continued downward pressure, albeit at a decelerating rate, due to mature market dynamics and stringent regulatory oversight on manufacturing costs.

What is the current market status for Loratadine 10mg Oral Tablets (NDC: 00597-0053)?

NDC 00597-0053 refers to Loratadine 10mg oral tablets, a widely available over-the-counter (OTC) and prescription antihistamine used for the relief of symptoms of seasonal allergic rhinitis and chronic urticaria. The market for Loratadine is mature and saturated with generic products. Key characteristics include:

• High Generic Penetration: Loratadine has been off-patent for many years, leading to a market dominated by generic manufacturers. The original innovator product, Claritin, is now also available as a generic.
• Stable Demand: Allergic rhinitis and urticaria are common conditions with consistent prevalence, ensuring a steady demand for effective antihistamines like Loratadine.
• Competitive Landscape: The market features numerous active pharmaceutical ingredient (API) suppliers and finished dosage form manufacturers, primarily from India and China, alongside domestic producers. This intense competition keeps prices low.
• Regulatory Environment: Compliance with Current Good Manufacturing Practices (cGMP) is critical, and any disruptions in supply chains or manufacturing issues can impact market availability and pricing, although these are usually short-lived in a well-supplied market.
• Distribution Channels: Loratadine 10mg tablets are widely distributed through retail pharmacies (both chain and independent), mass merchandisers, online pharmacies, and institutional healthcare providers.
• Product Formulations: While the focus is on 10mg oral tablets, Loratadine is also available in other dosage forms such as liquids and dissolvable tablets, though the 10mg tablet is the most common presentation.

The average wholesale price (AWP) for Loratadine 10mg tablets varies significantly based on the manufacturer, packaging size, and the specific payer contract. However, typical wholesale acquisition costs (WAC) for generic Loratadine 10mg tablets are in the range of \$0.05 to \$0.20 per tablet. This reflects the commoditized nature of the product.

Who are the key manufacturers and suppliers of Loratadine 10mg Oral Tablets (NDC: 00597-0053)?

The market for Loratadine 10mg oral tablets (NDC: 00597-0053) is populated by a large number of generic manufacturers. Identifying a singular "NDC: 00597-0053" is often problematic as this specific NDC might represent a particular manufacturer's product at a given time, and manufacturers can switch or have multiple NDCs for similar products. However, based on market presence and common suppliers of Loratadine generics, key players often include:

• Generic Manufacturers:

  • Teva Pharmaceuticals
  • Dr. Reddy's Laboratories
  • Aurobindo Pharma
  • Mylan (now Viatris)
  • Sun Pharmaceutical Industries
  • Lupin Pharmaceuticals
  • Amneal Pharmaceuticals
  • Prasco Laboratories (often for private label)
  • Major retail store brands (e.g., CVS, Walgreens, Walmart) often contract with these or other generic manufacturers for their private label products.

• API Suppliers: The Active Pharmaceutical Ingredient (API) for Loratadine is largely sourced from international manufacturers, predominantly in India and China. Major API suppliers for Loratadine include:

  • Divi's Laboratories
  • Hetero Drugs
  • Laurus Labs
  • Various Chinese API manufacturers.

The specific manufacturer associated with NDC 00597-0053 would require access to current FDA UDI databases or specific product recall information, as NDC assignments can be dynamic. However, the companies listed above are representative of those that consistently produce and distribute Loratadine generics.

What are the primary drivers of demand and supply for Loratadine 10mg Oral Tablets (NDC: 00597-0053)?

Demand Drivers:

• Prevalence of Allergies: Seasonal allergic rhinitis (hay fever) and perennial allergic rhinitis affect a significant portion of the global population, creating a consistent need for antihistamines.
• Chronic Urticaria: Loratadine is also indicated for the treatment of chronic hives, a condition that requires long-term symptom management.
• Over-the-Counter Availability: The accessibility of Loratadine as an OTC medication in many markets lowers the barrier to entry for consumers, driving widespread use for self-treatment of allergy symptoms.
• Favorable Safety Profile: Compared to first-generation antihistamines, Loratadine is a non-sedating (or less sedating) antihistamine, making it a preferred choice for individuals who need to remain alert during the day.
• Cost-Effectiveness: As a generic medication, Loratadine is significantly cheaper than branded alternatives and many newer antihistamines, making it an attractive option for price-sensitive consumers and healthcare systems.

Supply Drivers:

• Mature Generic Market: The patent for Loratadine has long expired, allowing numerous generic manufacturers to enter the market. This competition ensures a robust supply.
• Global API Manufacturing Capacity: Large-scale API production facilities, particularly in Asia, provide a consistent and cost-effective supply of the active ingredient.
• Established Manufacturing Processes: The synthesis and formulation of Loratadine are well-established, leading to efficient and high-volume production capabilities among generic drug makers.
• Retail and Pharmacy Network: Extensive distribution networks ensure broad availability in pharmacies and retail outlets, facilitating consistent supply to meet consumer demand.
• Regulatory Approvals: Regulatory bodies like the FDA in the United States approve multiple generic versions, fostering a competitive supply environment.

What is the projected price trend for Loratadine 10mg Oral Tablets (NDC: 00597-0053) over the next five years?

Price projections for Loratadine 10mg oral tablets (NDC: 00597-0053) over the next five years indicate a continuation of the current trend of stable to slightly declining prices, with the rate of decline slowing.

• 2024-2025: Expect prices to remain largely stable, potentially seeing minor fluctuations due to inventory adjustments and minor supply chain disruptions. The WAC is likely to remain in the \$0.05 - \$0.20 per tablet range.
• 2026-2027: A gradual, low-digit percentage decline (e.g., 1-3% annually) is anticipated as additional generic manufacturers may enter or expand their market share, particularly if cost pressures on API production or manufacturing efficiency increase. Competition will intensify, but the market is already highly competitive, limiting significant drops.
• 2028-2029: The rate of price decline is expected to further decelerate, possibly stabilizing or showing minimal year-over-year changes. The market has reached a commoditized state where substantial price reductions are difficult to achieve without significant cost efficiencies in manufacturing or API sourcing. Major price shifts would likely be triggered by unexpected regulatory changes affecting manufacturing or a significant shift in demand drivers, neither of which is currently forecasted.

Factors influencing price projections:

• Manufacturing Costs: Fluctuations in raw material costs (API synthesis chemicals), energy prices, and labor can impact overall manufacturing expenses, although for highly commoditized generics, these are often absorbed through efficiency gains rather than passed directly to prices.
• Competition: The entry of new generic competitors or consolidation among existing players can influence pricing strategies. However, with numerous players already, new entries are less likely to cause dramatic price shifts.
• Regulatory Scrutiny: Increased regulatory scrutiny on manufacturing quality or import policies could temporarily disrupt supply or increase compliance costs, but is unlikely to cause sustained price inflation in this market.
• Reimbursement Policies: Pharmacy benefit manager (PBM) negotiations and formulary placements can influence demand and thus indirectly affect pricing, but the OTC nature of much of Loratadine sales limits this impact compared to prescription drugs.
• Market Saturation: The market is already highly saturated. Significant price declines are constrained by the existing low-price points. Any further decreases will likely be marginal.

Table 1: Projected Average Wholesale Price (AWP) Range for Loratadine 10mg Tablets (per tablet)

Year	Projected AWP Range (\$)
2024	\$0.06 - \$0.21
2025	\$0.06 - \$0.21
2026	\$0.05 - \$0.20
2027	\$0.05 - \$0.20
2028	\$0.05 - \$0.19
2029	\$0.05 - \$0.19

Note: AWP is an estimate and can vary significantly by distributor, contract, and package size. This projection focuses on trends in the generic market.

What are the regulatory and quality control considerations impacting the production of Loratadine 10mg Oral Tablets (NDC: 00597-0053)?

Regulatory and quality control considerations are paramount for the production of Loratadine 10mg oral tablets (NDC: 00597-0053) and significantly influence market entry, pricing, and supply reliability.

• Current Good Manufacturing Practices (cGMP): All manufacturers and API suppliers must adhere to strict cGMP guidelines established by regulatory bodies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and others. This includes controls over:

  • Facility and Equipment: Validation, maintenance, and cleanliness.
  • Raw Material Testing: Purity, identity, and quality of APIs and excipients.
  • Manufacturing Processes: Validation, in-process controls, and batch records.
  • Finished Product Testing: Assays for potency, dissolution, impurities, and uniformity.
  • Stability Studies: Ensuring product quality over its shelf life.
  • Documentation and Record-Keeping: Comprehensive and accurate records for traceability.

• ANDA Process (U.S.): For generic drugs in the U.S., manufacturers must submit an Abbreviated New Drug Application (ANDA) to the FDA. This process requires demonstrating bioequivalence to the reference listed drug and adherence to all cGMP standards [1]. Successful ANDA approval is a prerequisite for market entry.

• Drug Master Files (DMFs): API manufacturers maintain DMFs submitted to regulatory agencies, detailing the manufacturing process, facilities, and quality controls for the API. Finished dosage form manufacturers rely on these DMFs to support their ANDA submissions.

• Impurity Profiling: Regulatory agencies have increasingly focused on controlling impurities in pharmaceutical products, including genotoxic impurities. Manufacturers must rigorously test for and control impurities within acceptable limits, which can add complexity and cost to the manufacturing process.

• Supply Chain Security: Regulatory bodies are emphasizing supply chain integrity to prevent counterfeiting and ensure product quality throughout distribution. This includes track-and-trace requirements (e.g., Drug Supply Chain Security Act in the U.S.) [2].

• International Regulations: Manufacturers exporting to different countries must comply with the specific regulations of each target market, which can vary in stringency and requirements.

• Quality Audits and Inspections: Manufacturers are subject to regular inspections by regulatory authorities. Failure to meet cGMP standards can result in warning letters, import alerts, product recalls, or suspension of manufacturing operations, impacting supply and potentially increasing costs due to remediation efforts.

These stringent controls, while essential for public safety, contribute to the baseline cost of production. However, in a market as mature and competitive as Loratadine, manufacturers often achieve economies of scale and process efficiencies to mitigate these costs and remain competitive.

What are the competitive threats and opportunities for Loratadine 10mg Oral Tablets (NDC: 00597-0053)?

The market for Loratadine 10mg oral tablets (NDC: 00597-0053) faces several competitive threats and also presents limited but specific opportunities.

Competitive Threats:

• Newer Generation Antihistamines: While Loratadine is effective and non-sedating, newer generation antihistamines (e.g., Cetirizine, Fexofenadine, Levocetirizine, Desloratadine) offer comparable efficacy and may have slightly different side effect profiles or dosing frequencies that appeal to some consumers. Some of these are also available generically, intensifying the competition within the broader antihistamine class.
• Combination Products: Allergy sufferers may opt for combination products that include an antihistamine along with a decongestant or nasal steroid, potentially reducing demand for single-ingredient Loratadine.
• Increased Generic Competition: The continuous entry of new generic manufacturers, particularly those with highly optimized supply chains and cost structures, can drive down prices and market share for established players.
• Private Label Dominance: Large retail chains and pharmacies increasingly push their own private label brands of Loratadine, often sourced from multiple generic manufacturers, which can lead to price wars and squeezed margins for branded generic suppliers.
• Potential for Biosimilar or Interchangeable Biologic Entry (Not Applicable to Loratadine): While not a biologic, this is a general threat within the pharmaceutical industry for novel drugs and is mentioned for context of evolving competitive landscapes. For small molecule generics like Loratadine, the threat is primarily from other small molecule generics.

Opportunities:

• Emerging Markets: Growth in healthcare access and disposable income in emerging economies can create new demand for affordable allergy medications like Loratadine.
• Supply Chain Optimization: Manufacturers who can further optimize their API sourcing, manufacturing efficiency, and logistics can maintain competitive pricing and potentially gain market share.
• Contract Manufacturing for Private Labels: Opportunities exist for manufacturers to serve as reliable contract manufacturers for large retail chains and their private label programs.
• Value-Added Services: While difficult in a commoditized market, offering specific packaging sizes, bulk options for institutions, or enhanced customer service can provide a minor competitive edge.
• Focus on Compliance and Quality: Companies with a proven track record of unwavering regulatory compliance and high-quality manufacturing can build trust and secure contracts, especially with larger buyers who prioritize supply chain reliability.

The primary competitive dynamic is price. Manufacturers with the lowest cost of goods sold and most efficient market access are best positioned. Innovation in this space is limited to process improvements and cost reductions rather than novel therapeutic advancements.

Key Takeaways

Loratadine 10mg oral tablets (NDC: 00597-0053) operate within a highly competitive and mature generic drug market. Demand is stable, driven by the widespread prevalence of allergic conditions and the drug's favorable non-sedating profile and cost-effectiveness. The market is characterized by numerous global generic manufacturers and API suppliers, leading to intense price pressure.

Price projections indicate continued stability with a decelerating rate of decline over the next five years. Manufacturers must navigate stringent regulatory requirements (cGMP, ANDA processes) which, while increasing baseline costs, also serve to consolidate the market among compliant players. The primary competitive threats stem from ongoing generic competition and the dominance of private label brands. Opportunities lie in supply chain optimization, serving private label needs, and potential expansion into emerging markets.

FAQs

1. What is the typical shelf life of Loratadine 10mg oral tablets (NDC: 00597-0053)? The typical shelf life for Loratadine 10mg oral tablets is 24 to 36 months from the date of manufacture, provided the product is stored under recommended conditions (e.g., at room temperature, protected from moisture and light). This is determined by stability studies conducted by the manufacturer and indicated on the product packaging.

2. How does the cost of Loratadine 10mg oral tablets (NDC: 00597-0053) compare to its branded equivalent, Claritin? As a generic drug, Loratadine 10mg oral tablets are significantly less expensive than the original branded product, Claritin. The price difference can range from 50% to over 90%, depending on the retailer, packaging size, and any available coupons or discounts for the branded product.

3. What are the main side effects associated with Loratadine 10mg oral tablets (NDC: 00597-0053)? The most common side effects of Loratadine include headache, fatigue, drowsiness (though less common than with first-generation antihistamines), dry mouth, and gastrointestinal upset. Serious side effects are rare.

4. Can Loratadine 10mg oral tablets (NDC: 00597-0053) be used for long-term management of allergies? Yes, Loratadine is generally considered safe for long-term, daily use for individuals with chronic allergic rhinitis or chronic urticaria, as it is a non-sedating antihistamine and does not typically lead to tolerance with continuous use. However, consulting with a healthcare professional is recommended for chronic conditions.

5. What are the primary regulatory hurdles for a new manufacturer entering the Loratadine 10mg oral tablet (NDC: 00597-0053) market in the U.S.? The primary regulatory hurdle is obtaining FDA approval through an Abbreviated New Drug Application (ANDA). This requires demonstrating bioequivalence to the reference listed drug, adherence to Current Good Manufacturing Practices (cGMP) for both the finished product and the API, and submission of comprehensive quality and manufacturing data.

Citations

[1] U.S. Food & Drug Administration. (n.d.). Generic Drugs Program. Retrieved from https://www.fda.gov/drugs/generic-drugs/generic-drugs-program

[2] U.S. Food & Drug Administration. (n.d.). Drug Supply Chain Security Act (DSCSA). Retrieved from https://www.fda.gov/drugs/drug-supply-chain-integrity/drug-supply-chain-security-act-dscsa