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Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs).
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 ...
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]
Johnson & Johnson’s arthritis drug Stelara carries an annual list price of $79,000 in the US. In Germany, it’s $30,000; in Canada, it’s $20,000; in the UK, it’s $16,000; in Japan, it’s ...
Drug Main indication Trade name 2015 2016 ... Eliquis 9872 7395 4 lenalidomide: ... Generic Name Sales Q1 2014 Sales ($000)
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 ...