With the launch of Prozac (fluoxetine), Eli Lilly changed the way depression was globally viewed and treated. One of their follow-on compounds, Cymbalta (duloxetine) achieved peaks sales of almost $5 billion dollars in a single year. The names in parentheses are generic product names.
When a branded drug like Cymbalta loses its patent exclusivity, generic brands enter the market quickly. Please review the links below and data provided and answer the memo topics. Feel free to consider other sources for reference as desired. Please answer each question thoroughly and detailed with reasoning to your answers.
Links:
Generic Drug Facts, FDA:
https://www.fda.gov/drugs/generic-drugs/generic-drug-facts
Generic Drugs: Questions & Answers, FDA:
https://www.fda.gov/drugs/questions-answers/generic-drugs-questions-answers
Guidance for Industry 180-Day Exclusivity: Questions and Answers, FDA:
https://www.fda.gov/media/102650/download
Prasco Labs website:
https://prasco.com/who-we-are.html
Memo Topics:
Why are generic drugs less expensive than their brand name counterparts?
What are the potential market outcomes, positive and negative, of being the first filer for an ANDA?
Using the image file Duloxetine HCL Market Share (above) as reference, who do you believe was the first entrant into this generic market? Why?
Take a look at Prasco Labs (https://prasco.com/who-we-are.html). Whats interesting about this particular generic company?
If a client of yours was considering launching a generic duloxetine, would you recommend them to do so? Why or why not?
