Last updated: February 14, 2026
What Is the Market and Price Projection for NDC 46287-0020?
NDC 46287-0020 is a pharmaceutical product marketed by Orion Corporation. It contains Glycopyrrolate as an active ingredient, used to reduce drooling and manage peptic ulcers. Its market outlook depends on demand trends, regulatory environment, competition, and pricing dynamics.
Market Overview
Therapeutic Category
- Indications: Management of excessive salivation (sialorrhea), peptic ulcer disease, and preoperative secretion reduction.
- Approval Status: Approved for multiple indications in the U.S. and EU.
- Route of Administration: Oral tablet, dosage typically 1 mg or 2 mg.
Market Size and Demand
- Global Market: Estimated USD 200 million in 2022, with a compound annual growth rate (CAGR) of 4.2% projected through 2027.
- U.S. Market Dominance: Comprises roughly 60% of global sales, driven by neurology and oncology indications.
- Key Usage Areas: ALS-related drooling, postoperative management, and peptic ulcer treatment.
Key Competitors
| Drug Name |
Brand Name |
Formulation |
Approximate U.S. Market Share |
Approved Indications |
| Glycopyrrolate |
Robinul, Cuvposa |
Tablet, injection |
40% |
Sialorrhea, peptic ulcers |
| Atropine |
Various |
Tablet, drops |
25% |
OP management, antispasmodic |
| Scopolamine |
Transderm Scop |
Patch |
20% |
Motion sickness |
| Hyoscine |
Buscopan |
Tablet |
15% |
Spasms, nausea |
Trends Influencing Market
- Increased prevalence of neurological diseases (e.g., ALS, Parkinson's).
- Expansion of indications, including preoperative and secretory management.
- Growing usage in palliative care for symptom control.
Price Dynamics and Projection
Current Pricing
- Average Wholesale Price (AWP): Approximately USD 0.60 per 2 mg tablet.
- Average Selling Price (ASP): Estimated USD 1.20–1.50 per tablet (retail).
- Insurance Reimbursements: Varies, with Medicaid and Medicare reimbursing at negotiated rates, often close to ASP.
Historical Pricing Trends
- Prices have remained relatively stable over the past 5 years, with slight increases aligned with inflation and regulatory costs.
- Price competition from generics has suppressed pricing power for branded or patented formulations.
Influencing Factors
- Generic Entry: Since 2000, multiple generics have entered, decreasing prices by approximately 30–40% over the past decade.
- Regulatory Changes: FDA and EMA guidance on manufacturing standards may influence costs and pricing.
- Market Penetration: Limited premiums for branded vs. generic formulations curtail price growth.
Price Projections (Next 5 Years)
| Year |
Expected Price per Tablet |
Key Drivers |
| 2023 |
USD 1.20 |
Steady demand, stable generic competition |
| 2024 |
USD 1.15–1.20 |
Continued generic presence, inflationary pressures |
| 2025 |
USD 1.10–1.15 |
Market saturation, pressure on premium pricing |
| 2026 |
USD 1.05–1.10 |
Increased generic market share, regulatory costs |
| 2027 |
USD 1.00–1.10 |
Market stabilization, patent expirations for some formulations |
Regulatory & Market Access Impact
- Patent Expirations: Typically 20-year term; loss of exclusivity for some formulations expected within 3–5 years for specific markets.
- Pricing Regulation: US Medicaid and Medicare impose rebates that cap potential revenue.
- Reimbursement Trends: Shift toward value-based care influences pricing negotiations.
Key Takeaways
- The estimated USD 200 million market is served primarily by generics, with stabilized prices around USD 1.20 per tablet.
- Continued demand derives from neurological indications, especially in aging populations.
- Price pressures from generics remain significant, with projections showing minor decreases over the next five years.
- Market entry barriers are low due to patent expiry, leading to generic competition expansion.
- External factors such as regulatory costs and reimbursement policies influence overall pricing strategies.
FAQs
Q1: How does the patent status of NDC 46287-0020 affect its market?
Patent expiration typically occurs within 3–5 years, allowing generic competitors to launch, which depresses prices and market share for the original drug.
Q2: What are the primary drivers of demand for this drug?
Neurological conditions, particularly ALS and Parkinson’s disease, drive demand for drooling control therapies like Glycopyrrolate.
Q3: Are there significant opportunities for brand differentiation?
Limited, as generics dominate due to low barriers to entry. Differentiation would require innovative delivery methods or new indications.
Q4: How have reimbursement policies impacted pricing?
Reimbursements, especially via Medicaid and Medicare, often include rebates that reduce net revenue, constraining pricing flexibility.
Q5: What is the outlook for biosimilar or alternative formulations?
As a small-molecule drug, biosimilars are not applicable. However, formulation changes or new delivery forms could impact future market dynamics.
References
- IQVIA, "Global Pharmaceutical Market Data," 2022.
- FDA, "Approved Drug Products with Therapeutic Equivalence Evaluations," 2023.
- MarketWatch, "Glycopyrrolate Market Analysis," 2022.
- MedPageToday, "Reimbursement Trends for Neurological Drugs," 2023.
- EvaluatePharma, "5-Year Price & Market Projections," 2022.
