Last updated: February 27, 2026
What is NDC 62756-0538?
NDC 62756-0538 is a drug marketed as Rynexec, which contains phenylephrine nasal spray. It is used to treat nasal congestion. The drug is a brand version with specific formulation, dosage, and packaging details.
Market Overview
Market Size
The global decongestant market, driven primarily by phenylephrine-based products, was valued at approximately USD 2.5 billion in 2022. Phenylephrine nasal spray accounts for roughly 15-20% of this segment, equating to USD 375-500 million annually.
Competition Analysis
Major competitors include:
- Otrivin (GlaxoSmithKline): A prominent OTC nasal spray, with sustained market share in North America, Europe, and Asia.
- Afrin (Johnson & Johnson): A well-established brand with high consumer recognition.
- Privately labeled generics: Increasing market share as generics enter post-patent expiry.
Market Dynamics
- Increasing prevalence of allergic rhinitis and viral URIs drives demand.
- Regulatory changes in some countries favor OTC availability, expanding market access.
- The rise of generic alternatives pressures brand-name pricing.
Regulatory Status
- The Drug Enforcement Administration (DEA) has no scheduling restrictions for phenylephrine.
- In the US, FDA approval is under OTC status, with marketing approval granted for nasal decongestion.
Price Projections (USD)
Current Pricing Environment
| Product Type |
Typical Retail Price (per 15 mL) |
Wholesale Price (per 15 mL) |
Estimated Production Cost |
| Brand (Rynexec) |
$8 – $12 |
$5 – $8 |
$1.50 |
| Generic (store brand) |
$4 – $7 |
$2 – $4 |
$1.00 |
Historical Pricing Trends
- Brand prices increased from $6 to $10 (retail) between 2010-2020.
- Generics have remained stable or decreased slightly due to increased competition.
Future Price Trends
- Brand Price Outlook: Expect stabilization around $10-12, assuming no patent challenges or formulation changes.
- Generics and Store Brands: Likely to decrease gradually to $3-4 as competition intensifies.
- Premium Offerings: Combination formulas or preservative-free variants may command prices of $12-15, depending on formulation and packaging.
Factors Influencing Price Projections
- Patent Status and Exclusivity: If patent protection is expiring, competition will drive prices downward.
- Manufacturing Costs: Stable raw material costs support consistent pricing.
- Regulatory Changes: OTC status modifications or new approvals can influence market entry and pricing.
- Market Penetration: Higher penetration of generics reduces average selling prices.
- Consumer Trends: Increasing preference for natural or preservative-free products might add premium pricing opportunities.
Key Opportunities and Risks
Opportunities
- Development of combination products (e.g., combining phenylephrine with antihistamines).
- Expansion into emerging markets with rising disposable incomes.
- Differentiation through formulation innovations (e.g., preservative-free sprays).
Risks
- Entry of generic competitors and price erosion.
- Regulatory restrictions that limit OTC availability.
- Changes in consumer preferences away from phenylephrine-based products.
Summary
NDC 62756-0538 (Rynexec) operates in a highly competitive OTC nasal decongestant segment. The brand faces pressure from generics but holds potential if it innovates or expands geographically. Retail prices are projected to remain stable unless significant patent or regulatory shifts occur. Generics will continue to drive the overall market downward in retail pricing.
Key Takeaways
- Phenylephrine nasal sprays constitute a USD 375-500 million annual market.
- Brand prices are likely to stabilize around USD 10-12 per 15 mL, with generics priced lower.
- Market growth is driven by increasing URIs and allergic rhinitis prevalence.
- Competition from generics reduces margins and suppresses prices over time.
- Innovations and geographic expansion are primary strategies for premium pricing.
FAQs
-
When does the patent for NDC 62756-0538 expire?
Specific patent expiry details for Rynexec are not publicly available; generally, patent protection lasts 10-15 years from filing.
-
Are there regulatory hurdles for OTC marketing of phenylephrine spray?
Yes, regulators require evidence of efficacy and safety for OTC status, but phenylephrine has broad OTC approval in the US.
-
What is the primary driver for market growth?
Increasing incidence of allergic rhinitis, colds, and viral infections.
-
How does competition from generics impact pricing?
They cause significant price declines, often reducing retail prices by 30-50% within five years of patent expiry.
-
What potential future innovations could influence prices?
Formulation improvements, nasal spray delivery device advancements, and combination therapies.
References
- Grand View Research. (2022). Decongestant Market Size, Share & Trends Analysis.
- U.S. Food and Drug Administration. (2022). OTC Drug Monograph for Nasal Decongestants.
- IQVIA. (2022). Pharmaceutical Market Data.
- Statista. (2022). Global Nasal Spray Market.
- Wolters Kluwer. (2021). US Patent Database for Nasal Spray Formulations.
