Issue 05/62 | November 16, 2005
"Authorized Generic" Drugs Under Scrutiny

According to a press release by the Generic Pharmaceutical Association (GPhA) on November 9, 2005, the FTC has said that it will look into the circumstances under which innovator companies launch so-called "authorized generics;" examine competition during the 180-day Hatch-Waxman exclusivity period; and further examine the long-term effect of generic drug entry on prescription drug prices.

The following day, Bloomberg.com reported that generic drug makers have been lobbying for new laws to stop expiring patent holders from receiving the six-month exclusivity period given to the first company to win approval for drugs that are going off patent. The issue of authorized generic copies has reportedly split the generic drug industry as companies such as Apotex and Mylan have refused to cooperate with big pharmaceutical companies, while others, such as Par and Watson Pharmaceuticals, reportedly do collaborate.

Still, none of the generic-makers appear ready to scrap the the exclusivity period entirely. "The Hatch- Waxman law struck a balance between competition and innovation, and that was the backbone of the generic industry," says Heather Bresch, a spokeswoman for Mylan. Stephen Mock, a spokesman for Par, also told Bloomburg that generic drug companies can generate about 80 percent of first-year sales and profit from during the exclusivity period.

Learn more about "The FDA Process for Approving Generic Drugs" and the "Abbreviated New Drug Application (ANDA) Process for Generic Drugs."

To discuss these topics further, please feel free to contact the author, William F. Heinze (bill.heinze@tkhr.com), at Thomas, Kayden, Horstemeyer & Risley LLP in Atlanta, Georgia USA.

The information contained in this email is provided for informational purposes only and does not represent legal advice. Neither the APLF nor the author intends to create an attorney client relationship by providing this information to you through this message.

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