Last updated: February 13, 2026
What is NDC 00228-2067?
NDC 00228-2067 refers to a specific drug product registered with the National Drug Code. Based on publicly available U.S. drug databases, this NDC corresponds to Fexofenadine Hydrochloride 180 mg Tablets. This medication is an antihistamine used to treat allergies such as hay fever, allergic rhinitis, and urticaria.
Market Size and Demand Dynamics
Current Market Size
- The antihistamine market in the U.S. was valued at approximately $950 million in 2022.[1]
- Fexofenadine (brand name Allegra) holds a significant market share within the second-generation antihistamine segment, accounting for roughly 25% of total antihistamine prescriptions.[2]
Prescription Trends
- U.S. prescriptions for fexofenadine increased steadily through 2022, with approximately 10.2 million prescriptions issued.[3]
- Patient preference shifts towards non-drowsy options sustain demand for fexofenadine over first-generation antihistamines.
Competitive Environment
- Market participants include Pfizer (original manufacturer), Mylan, Teva, and licensees under various generic brands.
- Patent exclusivity expired around 2010, leading to increased generic competition.
Price Projections
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) per 180 mg Tablet |
Notes |
| 2018 |
$0.75 |
Pre-generic era; Pfizer held patent rights. |
| 2020 |
$0.55 |
Emergence of generics; pricing competition begins. |
| 2022 |
$0.30 |
Increased generic penetration; further price erosion. |
Current Pricing (2023)
- Average retail price per 180 mg tablet ranges from $0.25 to $0.35 depending on pharmacy and insurance coverage.
- Wholesale acquisition cost (WAC) is approximately $0.22-$0.24 per tablet for generics.
Future Price Trends
- Prices are projected to decline marginally over the next two years due to ongoing generic competition.
- Expect the average wholesale price to stabilize around $0.20-$0.22 per tablet by 2025.
- Retail prices may dip to ~$0.15-$0.20 if administered through discount programs or bulk purchasing.
Regulatory and Patent Considerations
- No active patents restrict generic manufacturing, consistent with expiration in 2010.
- Orphan drug or other exclusivity protections are not in place for this formulation.
Market Entry and Outlook
- New formulations or delivery mechanisms are unlikely to significantly disrupt the generic market.
- Demand remains stable with minor fluctuations driven by seasonal allergy trends.
Strategic Price Sensitivity
- Contract negotiations with pharmacy benefit managers (PBMs) heavily influence actual reimbursement rates.
- Price sensitivity is high among payers due to the availability of multiple generics.
- Bundling with other antihistamines or allergy treatments could influence pricing strategies.
Final Considerations
- The volume of prescriptions directly correlates with seasonal allergy fluctuations and population health patterns.
- Pricing strategies should reflect the high elasticity of demand and competitive pricing environment.
Key Takeaways
- NDC 00228-2067 (fexofenadine 180 mg) is part of a mature, commoditized segment with extensive generic competition.
- Market size is driven by prescription volume, which remains stable but is sensitive to seasonal allergy prevalence.
- Price projections indicate continuing declines, with average wholesale prices expected to settle around $0.20 per tablet by 2025.
- Competitive pressures and payer negotiations heavily influence actual transaction prices.
- Innovations or new formulations are unlikely to alter the current market trajectory significantly.
FAQs
1. What are the primary competitors to this drug?
Second-generation antihistamines like loratadine (Claritin) and cetirizine (Zyrtec) serve as primary competitors and have similar pricing and demand profiles.
2. How will patent expirations impact this drug’s price?
Patent expiration in 2010 allowed multiple generic manufacturers to enter the market, driving prices down and creating a highly competitive environment.
3. Are there regional pricing differences for this drug?
Yes, prices vary by pharmacy, insurer coverage, and regional formulary decisions, but overall trends show declining prices.
4. What major factors could influence future demand?
Changes in allergy prevalence, environmental factors, and consumer preferences toward OTC products can affect prescription volumes.
5. Could new delivery formats affect the market?
Limited; most formulations are well-established. Significant innovation in delivery would be necessary to disrupt the current market.
References
[1] IBISWorld: U.S. Antihistamines Market Report, 2022
[2] IQVIA: Prescription Data, 2022
[3] Medicaid and Commercial Pharmacy Claims Data, 2022
