Generic & Branded Drug Market Entry

“Make better decisions: Finding and evaluating generic and branded drug market entry opportunities”

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Introduction 
Innovative and Follower Drugs
… Small-Molecule and Biologic Drugs
… Branded and Follower Drug Approval
Patents and Other Forms of Intellectual Property Protection
… Patents
… Trade Secrets
… Trademark
Regulatory Exclusivity
… Small-Molecule Drugs
… Biologic Drugs
Analyzing Patents and Litigation
… Patents as Sources of Information
… Patent Litigation
Market Size and Quality
… Prevalence, Presentation, and Prescription
… Drug Prices
Branded Drugs
… Market Size
… Market Protection and Competition
… Strategic Alignment
… Tracking Drugs in Development
… Lifecycle Management
Generic Entry
… Freedom to Operate
… Fixed and Variable Cost

… Market Entry Timing
… Litigate or Settle
… Skinny Label / Off-Label use
… Finding Low-Competition Opportunities
… Generics Outside the U.S.
… Branded Generics
Case Study: Identifying First Generic Entrants 
Case Study: Viagra Generic Entry
Case Study: Extracting Competitive Intelligence From Litigation
Appendices
… Drug Names
… FDA Orange Book
… Free Patent Databases
… Blogs and Web Resources
… Other Books

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