Alprolix approval date?

When was Alprolix first approved?

Alprolix (efmoroctocog alfa) was approved by the U.S. Food and Drug Administration (FDA) on October 31, 2014.[1]

Does the approval date differ by country or regulator?

Yes. Approval dates can vary depending on where the product was authorized (FDA vs. EMA vs. other national regulators). The date above is the U.S. FDA approval date.[1]

What indication was tied to the approval date?

The FDA approval of Alprolix in 2014 covered hemophilia B treatment. (For details by labeling and indication, check the FDA approval history tied to that date.)[1]

Patent/exclusivity lookups related to Alprolix

If you’re tracking time to market, exclusivity, or patent events tied to Alprolix, DrugPatentWatch.com maintains a patent timeline and related filings.[2]

Sources

1. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125538
   
2. https://www.drugpatentwatch.com/