Biotech Values

[DewDiligence]

FDA says it will allow "authorized generic" drugs

[“Authorized generics” are generics which are sold by the vendor of the branded drug. Authorized generics can be sold by the branded-drug company or its licensee even during the 180-day period of generic “exclusivity” granted under the Hatch-Waxman act. Hence authorized generics undercut the economic incentive for the true generic companies to get involved in the first place. See #msg-3463230 for Mylan’s request, which has now been denied, to halt the FDA’s allowance of these authorized generics.]

http://biz.yahoo.com/rc/040702/health_generics_1.html

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Friday July 2, 5:43 pm ET

WASHINGTON, July 2 (Reuters) - U.S. regulators on Friday rejected requests from Mylan Laboratories Inc. (NYSE:MYL - News) and Teva Pharmaceutical Industries Ltd. (Tel Aviv:TEVA.TA - News; NasdaqNM:TEVA - News) to prohibit "authorized generics," a tactic the companies said unfairly undermines sales of generic drug makers.

When the patent ends on a brand-name medicine, the first drug maker approved to sell a cheaper copy receives a 180-day period of exclusivity without competition from other generic versions.

Major drug makers have skirted that exclusivity by cutting deals with other generic firms to make so-called authorized generics during the 180-day period.

Mylan and Teva filed petitions with the Food and Drug Administration asking the agency to outlaw marketing of authorized generics during the exclusivity period.

The FDA on Friday said it denied the petitions.

"Marketing of authorized generics increases competition, promoting lower prices for pharmaceuticals," the FDA said in a statement.

Regulators also denied a petition from Pfizer Inc. (NYSE:PFE - News) that sought to keep generic companies from waiving the 180-day exclusivity period.

"FDA sees no reason to interfere with the marketing of authorized generics and waiving 180-day exclusivity, two long-standing, pro-competitive business practices," the agency said.

Officials at the three companies could not immediately be reached for comment.
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