Last updated: February 13, 2026
What is NDC 82009-0061?
NDC 82009-0061 identifies a specific pharmaceutical product listed in the National Drug Code database. The code corresponds to a proprietary or generic drug, with specifics including manufacturer, formulation, dosage, and packaging details.
Based on available data, NDC 82009-0061 corresponds to Loratadine 10 mg Oral Tablet, produced by Apotex Corp. The drug is indicated for allergy relief and chronic idiopathic urticaria.
What is the current market landscape for this drug?
Market Size and Demand
The market for allergy medications in the U.S. exceeds USD 2.5 billion annually, with Loratadine representing roughly 10-12% of this market. Sales are driven by both brand and generic formulations.
Key Competitors
- Claritin (Schering-Plough/ Bayer): The branded market leader, with sales peak at USD 1.2 billion pre-patent expiry in 2012.
- Generic Loratadine: Produced by multiple manufacturers, including Apotex, Mylan, and Sandoz, capturing most of the post-patent market.
Market Trends
- Increased demand due to allergy prevalence increase, with approximately 30% of adults and 40% of children affected.
- A shift toward generic options owing to private and public insurance cost containment strategies.
Regulatory Aspects
- Apotex's Loratadine tablets are FDA-approved, with No. 43 bioequivalence studies.
- Patent expiry for Claritin was in 2012, enabling generics to capture market share.
What are the key market dynamics impacting pricing?
Pricing History
- The average wholesale price (AWP) for generic Loratadine 10 mg tablets ranges from USD 0.03 to USD 0.05 per tablet.
- Brand-name Claritin has historically sold at USD 0.50 to USD 1.00 per tablet.
Market Entry and Competition
- Entry of multiple generics post-2012 has driven prices downward.
- Dose and packaging variations influence pricing; larger blister packs reduce per-unit costs.
Supply Chain Considerations
- Manufacturing capacity constraints are minimal, leading to price stability.
- Market shortages are rare, but price fluctuations can occur during supply disruptions.
What are price projections for NDC 82009-0061?
Short-to-Medium Term (Next 1-3 Years)
- Average Wholesale Price (AWP): Expected to remain between USD 0.03 to USD 0.05 per tablet, given current competitive landscape.
- Rebate and Discount Trends: Manufacturers and pharmacy benefit managers (PBMs) negotiate significant rebates, reducing actual net prices.
- Impact of Policy Changes: Increased pressure on generic drug prices from CMS and other payers could decrease net prices by an estimated 10-15%.
Long Term (Next 3-5 Years)
- Market Saturation: Continued entry of generics limits price increases; prices likely to remain stable or decline marginally.
- Potential Price Drivers:
- Introduction of combination formulations.
- Patent or exclusivity dispute resolutions.
- Changes in prescribing guidelines favoring or disfavoring loratadine.
Potential Price Range
| Scenario |
Price Range (USD per tablet) |
Factors Influencing |
| Conservative |
USD 0.025 - USD 0.035 |
Ongoing competition, patent stability |
| Moderate |
USD 0.035 - USD 0.045 |
Minor supply constraints, reformulations |
| Optimistic |
USD 0.045 - USD 0.05 |
Increased demand, supply shortages |
How does this compare to other antihistamines?
| Drug |
Typical Price per Tablet |
Market Share |
Patent Status |
Major Competitors |
| Loratadine |
USD 0.03 - USD 0.05 |
10-12% of allergy meds |
Patent expired in 2012 |
Cetirizine, Fexofenadine |
| Fexofenadine |
USD 0.20 - USD 0.50 |
Larger share post-2012 |
Patent expired 2018 |
Loratadine, Cetirizine |
The lower cost of loratadine compared to alternatives like cetirizine and fexofenadine sustains its competitiveness in the generic market.
What do regulatory and policy factors imply?
- Price Controls: Increased US government oversight on drug pricing could put further downward pressure on generics.
- Reimbursement Policies: Payer policies favor low-cost generics, encouraging discounts and rebates.
- Market Exclusivity: No current patent protections for Apotex’s loratadine; thus, prices are driven by competition.
Key Takeaways
- NDC 82009-0061 corresponds to Apotex’s loratadine 10 mg tablets.
- The market remains predominantly generics with stable prices, averaging USD 0.03 to USD 0.05 per tablet.
- Prices are unlikely to increase in the near term due to intense competition, but marginal decreases are probable.
- Supply chain stability keeps pricing predictable; policy shifts could influence future pricing trajectories.
- Market competitiveness is maintained by low-cost generics, with little room for significant pricing hikes.
FAQs
1. Is there potential for price increases in Loratadine generics?
Current market competition discourages significant price hikes. Only supply disruptions or regulatory changes might push prices upward.
2. How does the patent status affect pricing?
Loratadine’s patent expired in 2012, leading to multiple generics entering the market, which suppresses prices.
3. What factors could cause prices to decline?
Increased generic competition, pressure from payers, or reformulations lowering manufacturing costs could reduce prices further.
4. How do rebates influence the actual net price?
Rebates negotiated between manufacturers and PBMs can cut net prices by 30-50%, making the effective cost lower than the AWP.
5. Are there upcoming regulatory changes that could impact this drug’s market?
Potential steps toward drug price regulation may apply downward pressure, but no specific policy proposals target loratadine currently.
Sources:
[1] IQVIA. (2022). US Prescription Drug Market Data.
[2] FDA. (2022). Orange Book – Drug Patent & Exclusivity Data.
[3] GoodRx. (2023). Drug Price Trends Report.
[4] Elsevier’s Gold Standard Drug Database.
[5] MarketWatch. (2022). Over-the-counter and Allergy Medications Market Size and Trends.
