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What Is an "Authorized Generic" drug?

Coverage of specific drugs · updated Jul 26, 2019

As noted by the United States Food and Drug Administration (FDA):

"The term “authorized generic” drug is most commonly used to describe an approved, brand name drug that is marketed as a generic product without the brand name on its label. Other than the fact that it does not have the brand name on its label, it is the exact same drug product as the branded product. It may be marketed by the brand name drug company, or another company with the brand company’s permission. In some cases, even though it is the same as the brand name product, the authorized generic may be sold at a lower cost than the brand name drug."



As an example, in the April 20, 2017 press release, Teva Pharmaceuticals announced: "Teva Launches AirDuo™ RespiClick® and its Authorized Generic, Two Inhalers Containing Fluticasone Propionate and Salmeterol" and noted:

"AirDuo™ RespiClick® and its authorized generic are fixed-dose combination asthma therapies containing an ICS and a LABA, the same active ingredients as Advair®. The authorized generic is known as fluticasone propionate and salmeterol inhalation powder (multidose dry powder inhaler). Teva is launching both products at the same time in an effort to address the need for more affordable asthma treatment options in the U.S. Teva expects that sales of the authorized generic will represent most of the sales of the two products."

(source: http://www.tevapharm.com/news/teva_launches_airduo_respiclick_and_its
_authorized_generic_two_inhalers_containing_fluticasone_propionate_and_salmeterol_04_17.aspx)