Report Description Table of Contents TABLE OF CONTENTS PART I: MARKET INTELLIGENCE FRAMEWORK AND STRATEGIC CONTEXT 1. RESEARCH FRAMEWORK AND MARKET SCOPE ALIGNMENT 1.1. Defining the Research Scope 1.1.1. ADHD Therapeutic Overview and Market Boundaries 1.1.2. Focus on Schedule II Controlled Substances 1.1.3. Exclusion Criteria: Branded Drugs, Non-Generics, Non-Controlled Substances, Global Data 1.2. Strategic Lens for Aurobindo Pharma USA 1.2.1. Intended Use Cases: Pricing, Launch Planning, Market Access, Quota Modeling 1.2.2. Portfolio Planning Relevance: Pediatric, Adult, ER/IR Formats 1.3. Data Sources and Methodology 1.3.1. Primary and Secondary Data Sources 1.3.2. Market Sizing and Forecasting Approach 1.3.3. Price Normalization: AWP, WAC, AMP, FUL, NADAC, Net Price 1.3.4. Volume Projection and Generic Share Estimation 1.4. DEA Quota and Supply Modeling Techniques 1.4.1. Year-Wise Quota Allocation Framework 1.4.2. Forecast Sensitivity to Regulatory Restrictions 1.4.3. Shortage Adjustments and Supply Chain Volatility Factors PART II: U.S. MARKET SEGMENTATION, SIZE, AND FORECAST TRENDS 2. U.S. ADHD CONTROLLED SUBSTANCES MARKET SIZE AND SEGMENTATION (2021–2030) 2.1. Total Market Size and Growth Forecast 2.1.1. Revenue (USD Million), Units, Prescriptions 2.1.2. Historical Trends (2021–2024) and Forecast (2025–2030) 2.2. Market Segmentation by Drug Class 2.2.1. Stimulants: Amphetamine-Based, Methylphenidate-Based 2.2.2. Non-Stimulants: Atomoxetine, Clonidine, Guanfacine (Excluded) 2.3. Market Segmentation by Patient Age Group 2.3.1. Pediatric Market (Ages 3–12) 2.3.2. Adolescent Market (Ages 13–17) 2.3.3. Adult Market (Ages 18+) 2.4. Market Segmentation by Distribution Channel 2.4.1. Retail Pharmacies 2.4.2. Online and Mail-Order Pharmacies 2.4.3. Institutional and Closed-Door Pharmacies 2.5. State-Level Revenue and Volume Segmentation 2.5.1. Top 10 States by ADHD Controlled Substance Revenue (2024 Actuals) • California • Texas • Florida • New York • Pennsylvania • Illinois • Ohio • Georgia • North Carolina • Michigan • Others 2.5.2. State-Level Growth Forecast (2025–2030) 2.5.3. Retail vs Medicaid Share Split by State 2.5.4. Priority State Recommendations for Aurobindo PART III: MOLECULE-LEVEL COMMERCIAL ANALYSIS AND FORECASTING 3. COMMERCIAL PERFORMANCE AND FORECAST BY ADHD CONTROLLED MOLECULE 3.1. Amphetamine-Based Stimulants 3.1.1. Amphetamine Mixed Salts IR/ER (RLD: Adderall, Adderall XR) – Price and Volume Trends (2021–2024) – Forecasted Erosion Curve (2025–2030) – Competitor Benchmarking (Teva, Aurobindo, Lannett, Alvogen) – Quota Allocation and Retail Access Trends 3.1.2. Lisdexamfetamine (RLD: Vyvanse) – Market Entry and Early Erosion Impact – Pricing Benchmarks and PBM Tiering – Competitive Outlook (2024–2026) – Mail Order vs Retail Dispensing Impact 3.2. Methylphenidate-Based Stimulants 3.2.1. Methylphenidate IR (RLD: Ritalin) – Generic Penetration and State-Level Dispensing – Strength-Level Pricing Breakdown – ANDA Approval Timeline and Manufacturer Capacity 3.2.2. Methylphenidate ER (RLD: Concerta, Metadate CD, Ritalin LA) – OROS, LA, CD Format Comparison – Competitive Distribution Strategy and Market Access –Authorized Generics Impact on Pricing and Erosion 3.2.3. Dexmethylphenidate IR/ER (RLD: Focalin, Focalin XR) – Revenue Trends by Age Segment – Pricing Curves and PBM Coverage Variance 3.3. ER Suspensions and ODT Formulations 3.3.1. Adzenys XR-ODT, Dyanavel XR, Quillivant XR – Pediatric Preference and Format-Based Market Growth – Price and Distribution Benchmark by Strength – Generic Entry Impact (Teva, Tris, Neos) PART IV: PRICING, DISTRIBUTION, ACCESS, AND MARKET DISRUPTIONS 4. PRICE EROSION FORECASTS AND TREND MODELING 4.1. Historical Pricing Benchmarks 4.1.1. WAC, AWP, AMP, NADAC Data (2021–2024) 4.1.2. Net Price Trends and Dispensing Channel Discounts 4.1.3. Reimbursement Benchmarking by Payer Type: Medicaid vs Commercial 4.2. Forecasted Erosion Curves by Molecule (2025–2030) 4.2.1. Comparative Analysis of IR vs ER vs ODT/Suspensions 4.2.2. Price Inflection Points and Saturation Timelines 4.2.3. Molecule Erosion Scorecards 4.2.4. Post-Erosion Rebound Scenarios and Price Stabilization Zones 4.3. PBM Tiering and Rebate Impact on Net Price 4.3.1. PBM Coverage Analysis (CVS Caremark, Express Scripts, Optum) 4.3.2. Impact of Rebates on Generic Penetration 4.3.3. Manufacturer Positioning by Tier Access 5. U.S. DISTRIBUTION AND RETAIL ACCESS INFRASTRUCTURE 5.1. Wholesaler and Distributor Mapping 5.1.1. Cardinal, McKesson, AmerisourceBergen Roles 5.1.2. Contracting Dynamics and Fulfillment Volumes 5.2. Retail and Mail-Order Pharmacy Access 5.2.1. Presence Across CVS, Walgreens, Walmart, Rite Aid 5.2.2. Online Dispensing Trends for ADHD Generics 5.2.3. Post-Erosion Rebound Scenarios and Price Stabilization Zones 5.3. DEA Quota-Linked Distribution Risks 5.3.1. Annual Allocation Impact on Retail Inventory 5.3.2. Controlled Substance Handling and Refill Restrictions 6. MEDICAID AND STATE-LEVEL MARKET ACCESS 6.1. State PDL Inclusion and Tiering Status 6.1.1. Top 15 States by Volume and Access Score 6.1.2. Prior Authorization, Step Therapy, and Substitution Policies 6.2. Regional Access Opportunities 6.2.1. Pediatric/Adolescent Preference Regions 6.2.2. Medicaid vs Commercial Discrepancies 6.3. Aurobindo Target State Strategy 6.3.1. PBM Alignment by Region 6.3.2. Generic Opportunity Index (Volume + Margin) 7. MARKET DISRUPTIONS AND SUPPLY CHAIN VOLATILITY 7.1. 2022–2024 U.S. ADHD Drug Shortage Timeline 7.1.1. Causes: Quota Caps, API Disruptions, Manufacturing Gaps 7.1.2. Market Impact on Generic Share and Price Inflation 7.2. DEA Quota Reallocation and Manufacturer Performance 7.2.1. Historic Quota Distribution (2020–2024) 7.2.2. Manufacturer-Level Fulfillment Failures and Opportunities 7.3. Strategic Implications for Supply Resilience 7.3.1. Building Long-Term Channel Trust Through Stability 7.3.2. Aurobindo Differentiation via Supply Continuity PART V: REGULATORY, COMPETITIVE BENCHMARKING, AND STRATEGIC PLANNING 8. U.S. REGULATORY AND DEA COMPLIANCE LANDSCAPE 8.1. FDA Pathways for Generics 8.1.1. ANDA Requirements, Bioequivalence Standards 8.1.2. Labeling, Serialization, and Abuse-Deterrent Formulation Notes 8.2. DEA Controlled Substance Compliance 8.2.1. Quota Allocation Process and Approval Criteria 8.2.2. Reporting, Auditing, and Storage Standards 8.2.3. Risk Classification by Format (IR vs ER vs Liquid) 8.3. Compliance Performance Scorecard (2020–2024) 8.3.1. FDA Warning Letters and Inspection Summary 8.3.2. Recalls, Labeling Corrections, and Remediation Status 9. COMPETITIVE LANDSCAPE AND MANUFACTURER POSITIONING 9.1. Market Share by Molecule and Manufacturer 9.1.1. Teva, Aurobindo, Amneal, Tris, Lannett, Alvogen Profiles 9.1.2. Pricing vs Volume Positioning Matrix 9.2. Erosion Pressure and Price Resilience Index 9.2.1. Discounting Behavior Patterns 9.2.2. Launch Strategy vs Sustained Margin Outcomes 9.3. Compliance and Operational Risk Mapping 9.3.1. Recalls, Regulatory Flags, ANDA Approvals at Risk 9.4. Company Profiles: U.S. ADHD Controlled Substances Generics 9.4.1. Teva Pharmaceuticals USA 9.4.2. Aurobindo Pharma USA 9.4.3. Amneal Pharmaceuticals 9.4.4. Tris Pharma 9.4.5. Lannett Company Inc. 9.4.6. Alvogen / Almatica 9.4.7. Camber Pharmaceuticals 9.4.8. Granules Pharmaceuticals 9.4.9. Zydus Pharmaceuticals (USA) 9.4.10. Nostrum Laboratories 9.4.11. ScieGen Pharmaceuticals 10. STRATEGIC PLANNING AND GO-TO-MARKET OPTIMIZATION 10.1. Aurobindo ADHD Portfolio Mapping 10.1.1. Approved Products by Strength and Format 10.1.2. ANDA Status and Retail Channel Presence 10.2. Launch Readiness and Entry Timing Strategy 10.2.1. Pipeline Monitoring for Upcoming Molecule Expiries 10.2.2. ER vs IR Launch Risk Analysis 10.2.3. Authorized Generic Timing Considerations 10.3. Quota and Access Strategy 10.3.1. Projected Quota Needs vs Historical Allotments 10.3.2. Supply Chain Buffer and Fulfillment Capacity 11. APPENDIX: SUPPLEMENTAL TOOLS AND REFERENCE TABLES 11.1. Glossary of Regulatory and Commercial Terms 11.2. Pricing Benchmark Tables (2021–2024) 11.3. RLD–Generic Mapping Table 11.4. DEA Quota Allocation by Manufacturer 11.5. PBM Formulary Access Summary (Top 3 PBMs) 11.6. Watchlist Molecule: Mydayis (Triple-Bead ER Amphetamine) – Patent Status and Generic Opportunity Outlook Frequently Asked Question About This Report . .