Obtaining Generic Drug Approval in the United States

“This article is copyright by DrugPatentWatch and was originally published at https://www.drugpatentwatch.com/blog/obtaining-generic-drug-approval-in-the-united-states/”

The US Food and Drug Administration (FDA) approved over 700 generic drugs in 2015 alone, which was the highest to date, based on a report published by the FDA’s Office of Generic Drugs (OGD). The report also stated that the Agency approved 99 generic drugs in December 2015, which reflected FDA’s accomplishment report to Congress from March 2016.


These approvals are a vital way in which FDA is now capable of keeping the costs of medications in check, especially at a time when generic drugs account for approximately 88% of prescriptions doled out in the US. This important measure has saved the health system in the country by a whopping sum of $1.68 trillion from 2005-2014.

When can Generics Launch

Generic drugs are copies of a brand-name medication developed by another firm. Generally, these drugs sell at relatively lower prices, and promote competition in the pharmaceutical industry.

These drugs are the same in strength, safety, quality, dosing, the way they are taken, the way they work, and the way they ought to be used as that of the parent drug.

A generic drug can be marketed only after the patent of the brand-name product expires. For more, see When do Drug Patents Expire?

Read more in the original article

Picture: www.drugpatentwatch.com
Picture: www.drugpatentwatch.com

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