"Authorized Generic" Drugs Under Scrutiny
According to a November 10, 2005 report for Bloomburg.com, 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."
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."
1 Comments:
0730jejeLe résultat asics gel rocket bleu avis final voulu étant une vitesse de nike golf france contact balle élevée dans toute nike internationalist homme leather la face du club. Alors qu'il nike air force pas cher femme peut être des heures chaussure air jordan homme pas cher de travail aux États-Unis, il air jordan basket pas cher peut être quelques heures nike air max 90 iridescent femme en Chine et en Inde. nike air flight huarache og qs
Post a Comment
<< Home
© 2004-2007 William F. Heinze