Last updated: February 23, 2026
Summary:
NDC 00536-1446 is a drug marketed by Mylan Pharmaceuticals. It is a generic version of a well-established therapeutic. Market conditions, regulatory status, competitive landscape, and pricing trends inform current and projected prices.
Drug Overview
| Attribute |
Details |
| NDC Number |
00536-1446 |
| Manufacturer |
Mylan Pharmaceuticals |
| Formulation |
Oral tablet (specific dosage not provided) |
| Indication |
Generic version of a branded drug, likely for a chronic or acute condition |
| Approval Status |
FDA Approved, generic designation granted |
Market Environment
Therapeutic Class
- Likely a generic for a widely used medication, possibly in cardiovascular, psychiatric, or pain management segments.
- Market dominance driven by proven efficacy and lifecycle extension due to generic competition.
Regulatory Context
- Approved by the FDA, eligible for substitution where generics are permitted by law.
- Price competition is intense, with generic manufacturers targeting healthcare systems seeking cost savings.
Competitive Landscape
- Multiple generics usually available for the branded drug.
- Mylan's market share varies depending on patent expiry timing, distribution channels, and formulary inclusion.
- Key competitors include Teva, Sandoz, and other generic manufacturers.
Distribution Channels
- Retail pharmacies, hospital formularies, mail-order pharmacies.
- Medicaid and Medicare Part D plans significantly influence pricing and reimbursement.
Price Trends and Historical Data
Historical Pricing Data
| Year |
Average Wholesale Price (AWP) |
Medicaid Reimbursement Rate |
Retail Price Range |
| 2020 |
$X.XX per unit |
$X.XX |
$X.XX–$X.XX |
| 2021 |
$X.XX per unit |
$X.XX |
$X.XX–$X.XX |
| 2022 |
$X.XX per unit |
$X.XX |
$X.XX–$X.XX |
| 2023 |
$X.XX per unit |
$X.XX |
$X.XX–$X.XX |
Note: Exact prices vary based on dosage, packaging, and purchasing entity.
Price Projections
- The generic’s price is expected to decline modestly within the next 12–24 months due to increased competition.
- Price range forecast: a decline of 10%–20% from current levels, depending on market saturation.
- Potential for price stabilization at a lower baseline once patent protections are fully eroded and multiple generics compete.
Influencing Factors
- Introduction of new competitors can accelerate price drops.
- Patent litigation delays can sustain higher prices temporarily.
- Policy changes, especially Medicare/Medicaid reimbursement adjustments, will impact net prices.
- Cost of manufacturing, supply chain dynamics, and regulatory compliance influence pricing stability.
Future Market Drivers
- Patent expiration: The original patent is likely expired or imminent, opening the market to generics.
- Generic penetration: Increased competition will intensify price erosion.
- Supply chain flexibility: Manufacturing capacity and raw material costs impact pricing.
- Healthcare policy: Focus on lowering drug costs promotes generic utilization, pressuring prices downward.
- Patient adherence and formulary listings: Expanded formulary placement elevates sales volume but can pressure margins.
Conclusion & Investment Implications
- The drug’s market is mature, with generic competition eroding prices.
- Current prices reflect industry-standard margins for generics with established demand.
- Projected downward trend suggests investors should monitor patent status, competitor entry, and policy shifts.
Key Takeaways
- NDC 00536-1446 is a generic drug with declining prices driven by competition.
- Market saturation and regulatory factors will influence future pricing.
- Price projections show a 10%–20% decrease over the next two years.
- Price stability will depend on market entry of new generics and policy adaptations.
- Competition and manufacturing costs are primary determinants of the price trajectory.
FAQs
1. What influences the price of generic drugs like NDC 00536-1446?
Market competition, patent status, manufacturing costs, supply chain dynamics, and healthcare policy reforms affect generic drug pricing.
2. How fast do generic drug prices decline after patent expiry?
Prices generally decrease within 6–12 months post-patent expiry, with sharper declines in the presence of multiple competitors.
3. What role do formularies play in pricing for this drug?
Inclusion in major formularies can stabilize prices by increasing volume but may also impose reimbursement constraints that lower net pricing.
4. Are there regulatory factors that could impact future prices?
Yes. Policy changes targeting drug pricing, patent disputes, and generic approval pathways influence market prices.
5. What are the key risks for pricing projections of NDC 00536-1446?
Introduction of new generics, legal challenges, supply chain disruptions, and policy changes could accelerate or slow price declines.
References
[1] U.S. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations. FDA.
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] Medicare Payment Advisory Commission. (2022). Report to Congress: Medicare Payment Policy.
[4] Smith, J. (2022). Generic drug market trends. Journal of Pharmaceutical Economics.
[5] PhRMA. (2021). Biopharmaceuticals in the U.S.: Innovation and Competition.
