The Path Toward Generics: 2017’s Record-Breaking Year

Generic approvals totaled 1,027 last year.

2017 was record-breaking for generics. The FDA and the Office of Generic Drugs (OGD) deemed 1,027 new generic drugs for either full or tentative approval. This is 214 more than in 2016, which was another record year at 813 generic drug approvals. In total, 843 received full approval while 184 were listed as tentative, meaning although they are ready for approval and fit to be consumed by humans they cannot yet reach the market due to patent interference or because they are apart of an exclusive agreement (as with a brand name drug).

Almost 90% of the drugs prescribed in the US are generics. Another milestone in 2017, 80 drugs were approved as “first generic” drugs, or the first generic alternatives to a brand-name product. Also in 2017, the OGD provided industry guidance on developing products from tiotropium bromide inhalation powder (the generic of Spiriva Handihaler), used to treat COPD, to EpiPen (epinephrine) alternative Adrenaclick, used for emergency treatment of anaphylaxis.

This was also the year of the Generic Drug User Fee Amendments (known as GDUFA II), a law passed by Congress, which authorized the continued collection of user fees from generic drug manufacturers. GDUFA I, first enacted in 2012, allowed OGD to hire additional staff, so that from 2012 to 2017 FDA had additional resources to approve the record numbers of generic drug applications. This reauthorization means that continuing to advance generics is a priority. This also includes advanced generics made from complex drug product including inhalation or parenteral dosage forms. The most approvals came to the fore in November, when there were 84 full approvals and 23 tentative approvals.

This is the first year the number of generics has exceeded 1,000. The trend may continue, as generics provide a palpable cost savings. Over the last ten years, the use of generics has saved consumers a reported $1.67 trillion.


Guy Tiene

Guy supports the success of life science organizations by identifying synergies across research, content, marketing and communications resources to drive value for clients. With over 30 years of education and marketing experience and 18 years in the life sciences alone, Guy leads our editorial standards for client content, Pharma’s Almanac and Nice Insight research-based industry content as well as external communications for clients. Having served as head of global marketing and communications for a CMO, he also brings critical insight and guidance to all communications. Guy holds a Masters degree from Columbia University.