WORLD OF GENERIC DRUGS MODULE

FAQ

1. Does tentative approval give the company the right to manufacture and store its product during this period?
   1. Tentative approval means FDA is completely satisfied but there is still patent and/or exclusivity protection. The company can make and store the drug, but they cannot ship it across state lines.
2. Is it true that the Hatch-Waxman Act does not allow GENERIC companies to produce and manufacture products before the expiration date for marketing purposes?
   1. No this is not true. A generic company can make and maintain the supply of a generic product but can't sell or distribute that product in the United States until after the patent expires for the brand name product.
3. Can you explain how innovators and generic companies' manufacturing and storing time is mitigated by the Bolar exemption?

   1. See http://en.wikipedia.org/wiki/Roche_Products_v._Bolar_Pharmaceutical

      In that particular example, the product cannot ship across state lines in the United States. Nor can that product be sold within the company's state. It is common for FDA to see products sitting on the facility shelf during the agency's decision making process.