US Generic Drug Market Opportunity Outlook 2020 Report

“US Generic Drug Market Opportunity Outlook 2020” Report Highlight:

* Introduction to US Generic Drugs Market
* Hatch-Waxman Act & Its Implication
* FDA Review on Generic Drugs
* Supportive Features of US Generic Drug Laws
* Effect of Generic Drug Import on US Economy
* Methods to Achieve Higher Cost Arbitrage by Generic Drugs
* Role of Online Pharmacies in Expansion of US Generic Drugs Market
* US Generic Drugs Market Future Prospects

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Table of Contents

1. Introduction to US Generic Drugs Market



2. Hatch-Waxman Act & Its Implication

2.1 Premises of Hatch-Waxman Act

2.2 Benefits of Hatch-Waxman Act

2.3 Differential Measures in Hatch-Waxman Act



3. FDA Review on Generic Drugs



4. US Generic Drugs Market Overview



5. Supportive Features of US Generic Drug Laws

5.1 Features Considered by Generic Drug Developers

5.2 Factors Leading to Market Introduction of Generic Drugs



6. Patient Protection & Affordable Care Act (PPACA)

6.1 Objectives of Patient Protection & Affordable Care Act (PPACA)

6.2 Affordable Care Act & Savings on Generic Drug

6.3 Pharmacy Benefit Manager (PBM)

6.3.1 Pharmacy Networks

6.3.2 Mail Service Pharmacies

6.3.3 Health Information Technology (HIT)

6.4 Impact on Medicare Beneficiaries



7. Advancements in US Generic Drugs Market

7.1 Electronic Submission for Improved Processivity

7.2 Generic Drug User Fee Amendments (GDUFA) Fees

7.3 Fair Access for Safe & Timely Generics Act



8. Business Strategies of Branded & Generic Drug Manufacturers in US

8.1 Outsourcing of Research & Development

8.2 Merger & Acquisition by Branded Drug Companies

8.3 Marketing of Branded Drug in Generic Market

8.4 Monopoly in Generic Drug Manufacturing

8.5 Outsourcing Manufacturing to Emerging Countries



9. Methods to Achieve Higher Cost Arbitrage by Generic Drugs

9.1 Health Insurance Plans

9.2 Automatic Generic Substitution

9.2.1 Measures Taken for Generic Substitution

9.2.2 Counter Arguments against Generic Substitution

9.3 Cost Saving Plans by Retail Chains

9.4 Innovative Methods to Save Money on Generic Drug Prescription



10. Market Scenario of Branded & Generic Drugs in US



11. Effect of Generic Drug Import on US Economy

11.1 Why US Needs Generic Drug Import?

11.2 Factors Favoring Increase of Generic Drug Manufacturers in Emerging Countries

11.2.1 Regulatory Framework

11.2.2 Patent Loss

11.2.3 Increasing Number of Generic Drug Manufacturers

11.2.4 Implementation of International Standards

11.2.5 Lower Production Costs

11.3 US as Largest Importer of Generic Drugs

11.4 Potential Threat to US Generic Imports



12. Role of Online Pharmacies in Expansion of US Generic Drugs Market



13. US Generic Drugs Market Dynamics

13.1 Increasing Health Expenditure

13.2 Increasing Disease Incidences

13.3 Ageing US Population

13.4 Implementation of Hatch-Waxman Act

13.5 Patent Expiry of Blockbuster Drugs

13.6 Easy Manufacturing of Generic Drugs

13.7 Outsourcing Generic Drugs

13.8 Amenable Regulations

13.9 Implementation of Affordable Care Act





14. US Generic Drugs Market Commercialization Challenges

14.1 Patent Infringement Lawsuits

14.2 Lack of New Generic Drugs

14.3 Increasing Prices of Generic Drugs

14.4 Difficult Regulation of Generic Drugs



15. US Disease Profiling

15.1 Increasing Cancer Incidences

15.2 Cardiovascular Ailments

15.3 Central Nervous System (CNS) Diseases

15.3.1 Epilepsy

15.3.2 Alzheimer’s Disease

15.3.3 Parkinson’s Disease



16. US Generic Drugs Market Future Prospects



17. Competitive Landscape

17.1 Accord Healthcare

17.2 Alvogen

17.3 Amneal Pharmaceuticals

17.4 ANI Pharmaceuticals

17.5 Apotex

17.6 Aurobindo Pharma

17.7 Baxter Healthcare Corporation

17.8 Dr. Reddy's Laboratories

17.9 Fresenius Kabi

17.10 G & W Laboratories

17.11 Glenmark Generics

17.12 lmpax Laboratories

17.13 Lupin Pharmaceuticals

17.14 Mallinckrodt Pharmaceuticals

17.15 Momenta Pharmaceuticals

17.16 Mylan

17.17 Par Pharmaceutical

17.18 Perrigo Company

17.19 Sagent Pharmaceuticals

17.20 Sandoz

17.21 Sun Pharmaceutical Industries

17.22 Teva Pharmaceuticals

17.23 Therapeutic Proteins International

17.24 West- Ward Pharmaceuticals

17.25 Wockhardt

17.26 Zydus Pharmaceuticals

Figure 1-1: Difference between Generic & Branded Drugs

Figure 1-2: Similarities between Generic vs. Branded Drugs

Figure 1-3: Factors Responsible for Lesser Prices of Generic Drugs

Figure 1-4: Misconceptions Related to Generic Drugs

Figure 2-1: Main Premises of Hatch-Waxman Act

Figure 2-2: Implications of Hatch-Waxman Act

Figure 3-1: Application Required for Different Drugs

Figure 3-2: Benefits of New Chemical Entity

Figure 3-3: Increasing Generic Trade in US

Figure 3-4: Issues with Labelling of Generic Drugs

Figure 3-5: Patent Evergreening to Prevent Generic Drugs

Figure 4-1: Market Shares Occupied by Generic Drugs in US

Figure 4-2: Generic Drug Savings in US (Billion US$), 2005-2014

Figure 4-3: Generic Drug Saving in US by Therapy (Billion US$)

Figure 4-4: Generic Drugs Saving by Payer (%)

Figure 5-1: Features Considered by Generic Drug Developers

Figure 5-2: Factors Leading to Market Introduction of Generic Drugs

Figure 5-3: Approval Process of Generic Drugs

Figure 5-4: New Drug Application (NDA) for Branded Drugs

Figure 6-1: Objectives of Affordable Care Act

Figure 6-2: Offering Made by Affordable Care Act

Figure 6-3Objectives of Pharmacy Benefit Manager (PBM)

Figure 6-4: Different Roles Played by Pharmacy Benefit Manager (PBM)

Figure 7-1: Improvements in US Generic Market

Figure 8-1: Various Strategies Employed by Branded & Generic Drug Manufacturers

Figure 9-1: Few Methods to Achieve Higher Cost Arbitrage

Figure 9-2: Types of Managed Care Plan

Figure 9-3: Walmart’s Generic Drug Business Model

Figure 9-4: Benefits of Pill Splitting

Figure 10-1: Types of Drugs Available in US Pharmaceuticals Market

Figure 11-1: Favorable factors for Generic Drug Manufacturing in Emerging Countries

Figure 12-1: Mode of Operation of Online Pharmacies

Figure 12-2: Benefits of Online Pharmacy

Figure 13-1: Favorable Market Factors

Figure 13-2: Estimated Number of Older People (65 years of more) in US, 2020, 2040 & 2060

Figure 14-1: Commercialization Challenges



List of Tables



Table 2-1: Benefits of Hatch-Waxman Act

Table 4-1: Generics Drug Saving by State (US$)

Table 7-1: Generic Drug User Fee Amendments (GDUFA) Fees, Financial Year 2016

Table 9-1: Different Co-Pays According to Health Insurance Plan

Table 9-2: Few Important Drug Substitution Laws in US

Table 10-1: Prospective of US Patients on Generics & Branded Drugs

Table 10-2: Few Most Prescribed Branded Drugs in US, 2015

Table 10-3: Few Important Generic Drugs in US

Table 15-1: Few Generic & Branded Drugs for Cardiovascular Ailments

Table 15-2: Few Generic & Branded Drugs for Epilepsy available in US

Table 15-3: Few Alzheimer’s Disease Generic & Branded Drugs available in US

Table 15-4: Few Generic & Branded Drugs for Parkinson’s available in US

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