What is the US Food and Drug Administration (FDA) procedure for the conversion of an abbreviated new drug application (ANDA) status from final to tentative approval, following a court order for patent infringement?
Normally, when an applicant submits an ANDA under paragraph IV certification, this means that the patent for the reference product is invalid, unenforceable or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted.
In a new Manual of Policies and Procedures (MAPP) from the Office of Generic Drugs (OGD), the FDA lays out the policy for converting a paragraph IV ANDA’s final approval to tentative approval (TA) status when FDA receives a federal district court judgment that the patent is infringed and the ANDA approval becomes effective after expiration of the infringed patent. The MAPP also outlines the responsibilities of the various OGD offices in the process of conversion from final approval to TA due to the court order.
Furthermore, guidelines for triage of submissions related to patent infringement lawsuits are also outlined in the MAPP.
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