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USA speeds generic approvals

12-Aug-2003

The pharmaceutical industry is facing the possibility of earlier generic competition for its branded products from 18 August, when new legislation in the USA comes into effect.

On that date, the US Food and Drug Administration (FDA) will implement a final rule that will limit the number of automatic 30-month stays that may delay generic drug availability.

At present, companies receive a 30-month stay on the initiation of legal proceedings against a generic manufacturer that is alleged to have infringed a valid patent. In the future, a maximum of one stay will be permitted for each generic application.

The final rule also clarifies the types of drug patents that can be submitted for listing in the Orange Book, which serves as the agency's source for each drug's applicable patents.

The new legislation will prevent innovator drug companies from submitting new patent claims that are unlikely to represent substantial new innovation in order to extend their marketing protection, thus delaying the approval of a generic equivalent. From August 18, it will only allow the submission of patents that cover the active ingredient, the formulation and/or composition of the product and the method of use (i.e. injectable, tablet etc).

"The final rule balances innovator drugs companies' need for intellectual property protections and the desire to have equivalent generic drugs approved and marketed," said the agency in a statement.

These changes should enable generic drugs to reach the market sooner, but the FDA says it will also continue to make the generic drug approval process more efficient with the goal of lowering national health care costs by reducing the cost of bringing safe and effective generic drugs to market.

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