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Specializing in FDA Regulatory Matters

Generic Drugs

Generic drugs are copies of brand-name drugs and are the same as those brand name drugs in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.

Today, more than eight in 10 prescriptions filled in the United States are for generic drugs, saving consumers an estimated $8-$10 billion per year at retail pharmacies. The use of generic drugs is expected to grow as a number of popular drugs come off patent.

Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, making generics typically substantially less expensive than brand-name drugs.

Drug makers must file for generic approval via the Abbreviated New Drug Application (ANDA) which will demonstrate bioequivalence to the innovator drug.

GDUFA Associated Fees:

Generic drug manufacturers submitting human generic drug applications and certain application supplements are required to pay user fees under the Generic Drug User Fees Act (GDUFA). User fees are required in cases of:

  • Abbreviated new drug application (ANDA) or applicable amendment;
  • Prior approval supplement (PAS) or applicable amendment;
  • Type II active pharmaceutical ingredient (API) drug master file (DMF) that is referenced on or after October 1, 2012, in a generic drug submission to the FDA and for which the DMF fee has not already been paid;
  • Generic drug facility which is identified or intended to be identified in at least one generic drug submission that is pending or approved to produce a finished dosage form (FDF) of a human generic drug or an API contained in a human generic drug; and
  • Backlog ANDA which is pending on October 1, 2012, and that has not received a tentative approval prior to that date.

Generic Drug Facility Fees:

Any person that owns a facility that is intended to be identified in at least one generic drug submission that is pending or approved to produce one or more generic drug FDFs and/or APIs is also required to pay facility fees. Foreign and domestic fees are different and firms that have both foreign and domestic facilities are required to pay both fees, and likewise firms with two locations in the same country may be required to pay two facility fees, depending on the facilities proximity to each other.

Should your company have questions or need assistance with ANDAs, user fees, suitability petitions, GDUFA Self-Identification files or other FDA requirements, EAS is able to assist.