Tuesday, February 27, 2007

Generics to fight use of "authorized generic"

To counter the opportunity given to generics when proprietary drugs go "off patent", the branded companies have come up with new ways to salvage as much of their business as possible. One is through the pathway of the authorized generic / branded generic. Generic companies argue this direct competition is only possible because of a legal loophole that allows their branded rivals to launch cheaper versions of drugs just as they lose patent protection -- a loophole they hope to close with help from lawmakers.

Some policy analysts say generic drug makers face an uphill battle in changing the patent law to foreclose authorized generics, and separately that they must prepare for a fight on another front: proposed regulatory fees for their drug applications.
Under President Bush's budget released this month, generic drug makers would pay a fee each time they submit a new product for review. The Food and Drug Administration hopes to raise nearly $16 million through the program in fiscal 2008. Given that the FDA has a backlog of more than 1,200 generic drug applications, policymakers say user fees are worth considering. Lobbyists for the generic manufacturers are using the issue of the proposed fees to draw attention back to the patent-law loophole on authorized generics they say must be fixed.

In terms of the next battlegrounds, consider Schering Plough's allergy treatment Clarinex, Merck's osteoporosis drug Fosamax and Pfizer's hypertension drug Norvasc.

[from AP article: Generic drug firms fight patent loophole]

On patent reform, see post on IPFrontline-->


and previous post on IPBiz-->


On generics, see the IPBiz post: How will generic Zocor affect patented Lipitor?


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