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inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
The result is that apixaban generics will most likely not be available in the United States until at least 2026, but possibly 2031. [18] In July 2022, the Canadian generic drug company, Apotex Inc., obtained approval for marketing of apixaban. [39] [40] Pfizer reported revenue of US$6.747 billion for Eliquis in 2023. [41]
Authorized generics are prescription drugs produced by brand pharmaceutical companies and marketed under a private label, at generic prices. Authorized generics compete with generic products in that they are identical to their brand counterpart in both active and inactive ingredients; [1] whereas according to the U.S. Food and Drug Administration's Office of Generic Drugs, generic drugs are ...
WASHINGTON—The Biden administration is targeting the blood thinner Eliquis, diabetes treatment Jardiance and eight other medications for Medicare's first-ever drug price negotiations as it seeks ...
Drug innovators were given protections in two ways. First, a new kind of market exclusivity was introduced, by means of a new five-year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity; during that period the FDA cannot approve a generic version of the drug. [3]
Drug companies have argued that Medicare’s price negotiations could chill their research and development, leading to fewer new medications coming to market. This story has been updated with ...
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