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Finding and evaluating branded and generic market entry opportunities


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A presentation on finding and evaluating branded and generic market entry opportunities. For more, see my book "Make Better Decisions" or

Published in: Business
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Finding and evaluating branded and generic market entry opportunities

  1. 1. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Finding and Evaluating Branded and Generic Market Entry Opportunities YALI FRIEDMAN, PH.D. ADMIN@DRUGPATENTWATCH.COM
  2. 2. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Outcomes  Be a value-added partner for your branded and generic clients  Anticipate generic entry so you can prepare for changes in demand  Find and evaluate generic entry opportunities
  3. 3. πŸ’Š #MAKEBETTERDECISIONS βœ‰ More generics = lower prices Source: FDA
  4. 4. πŸ’Š #MAKEBETTERDECISIONS βœ‰ API volume increases after patent expiration
  5. 5. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Factors influencing generic entry decisions Ingredient Recipe and Testing Capital Distribution Effect Size Large Medium Large Medium Reason Trusted suppliers Compound properties known Experience with form, family, and ingredient reduces research expenditure Experience with form reduces development cost Reduces effort to find customers Source: M. Scott Morton, Fiona. (1999). Entry Decisions in the Generic Pharmaceutical Industry. RAND Journal of Economics. 30. 421-440.
  6. 6. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Strong generic first-mover advantage  1st generic can enjoy 80% market share advantage over 2nd entrant  Advantage can last for years Why?  Supplier decisions based on price, reputation, and recall history  Switching can introduce inventorying costs Costs of switching suppliers may favor first entrant Source: Yu, Y., Gupta S. Pioneering Advantage in Generic Drug Competition International Journal of Pharmaceutical and Healthcare Marketing
  7. 7. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Use sales to track demand for drug / category
  8. 8. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Branded vs. generic price may indicate competition
  9. 9. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Brand and generic may use different channels
  10. 10. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Find 505(b)(2) opportunities New Drug NDA / 505(b)(1) Generic Drug ANDA / 505(j) Hybrid 505(b)(2) Contains full reports of investigations of safety and effectiveness that were conducted by or for the applicant or for which the applicant has a right of reference or use. Relies on FDA’s finding that a previously approved reference listed drug is safe and effective ... May not be submitted if clinical investigations are necessary to establish the safety and effectiveness of the proposed drug product. Contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use. Source: FDA
  11. 11. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Most common 505(b)(2) types New formulation or manufacturer 43% New dosage form 29% New combination 13% Source: Freije, I., Lamouche, S., & Tanguay, M. (2019). Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements. Therapeutic Innovation & Regulatory Science.
  12. 12. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Increase client affinity with authorized generics
  13. 13. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Generic drug types Branded Generic Authorized Generic Traditional Generic Approval Process ANDA or 505(b)(2) NDA ANDA Relation to patent expiration Sold after patent expiration Can be sold before patent expiration Sold after drug patent expiration Cost Typically more than unbranded generic; less than branded drug Typically more than unbranded generic; less than branded drug Typically less than branded or authorized generics
  14. 14. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Branded generics
  15. 15. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Patent claim types β€’ If a patent claims the active ingredient it may be impossible to work around Compound claims β€’ If a generic entrant can work around a patented production process they may be able to launch Process claims β€’ Patents on specific formulations / dosage forms (e.g. transdermal patch or autoinjector) do not protect they active ingredient Formulation / Dosage claims β€’ If a drug has multiple uses, a generic may launch for unpatented indications using a skinny label Use claims
  16. 16. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Patent priority cheat-sheet Extended patents Litigated patents Compound-claiming patents Unexpired patents
  17. 17. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Finding low-competition opportunities
  18. 18. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Fast-follower: Day-181 Launch
  20. 20. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Get intel from patent litigation
  21. 21. πŸ’Š #MAKEBETTERDECISIONS βœ‰ $2.3mm to defend patent
  22. 22. πŸ’Š #MAKEBETTERDECISIONS βœ‰ 25% Royalty
  23. 23. πŸ’Š #MAKEBETTERDECISIONS βœ‰ How much was earned? $100mm royalty payments over 2y implies $200mm/yr in generic sales
  24. 24. πŸ’Š #MAKEBETTERDECISIONS βœ‰ Thank You Yali Friedman, Ph.D.