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Archived updates for Friday, November 11, 2005

"Authorized Generic" Drugs Under Scrutiny

According to a November 10, 2005 report for, generic drug makers are lobbying for new laws to stop expiring patent holders from receiving the 180-day Hatch-Waxman exclusivity period given to the first company to win approval for drugs that are going off patent.

The issue of so-called "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 genric-makers wants to scrap the the exclusivity period. "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.

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 authorized generics; examine competition during the 180-day exclusivity period; and further examine the long-term effect of generic drug entry on prescription drug prices.

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