Code of Federal Regulations Title 21. Food and Drugs § 21.516.31 Scope of MUMS–drug exclusive marketing rights

(a) After conditional approval or approval of an application for a MUMS–designated drug in the dosage form and for the intended use for which MUMS–drug designation has been granted, FDA will not conditionally approve or approve another application or abbreviated application for the same drug in the same dosage form for the same intended use before the expiration of 7 years after the date of conditional approval or approval as stated in the approval letter from FDA, except that such an application can be conditionally approved or approved sooner if, and at such time as, any of the following occurs:

(b) If an application for a MUMS drug cannot be approved until the expiration of the period of exclusive marketing of a MUMS–designated drug, FDA will so notify the sponsor in writing.