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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]
Bristol Myers Squibb's Eliquis, for example, was originally set to allow generic competition in 2019, but the drugmaker filed new patents that extended the drug's exclusivity for several more years.
The new drug price negotiations aim "to basically make drugs more affordable while also still allowing for profits to be made,” said Gretchen Jacobson, who researches Medicare issues at ...
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 ...
A generic drug is a chemically equivalent, cheaper version of a brand-name drug. A generic drug form is required to have the same dose, strength and active ingredient(s) as the brand name drug; thus, they carry the same risks and benefits. To ensure compliance, the FDA Generic Drugs Program conducts stringent reviews (3,500 inspections of ...
An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an ...
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