In a further confirmation that the low dose doxycycline market is a becoming a fighting ground, a recent press release states that Impax Laboratories has filed “Abbreviated New Drug Application ("ANDA") containing a paragraph IV certification for a generic version of ORACEA with the U.S. Food & Drug Administration ("FDA").”
This is a challenge to the patents held by Galderma, relating to the Oracea product.
In March we also read that Galderma was suing Mylan Pharmaceuticals, also over alleged Oracea patent infringements.
The announcement of this second ANDA:Generics challenge to Oracea can only be seen as good news for rosacea sufferers. If Oracea was available as a generic drug it would immediately become more affordable and thus accessible to rosacea sufferers.
Abbreviated New Drug Application (ANDA): Generics
An Abbreviated New Drug Application (ANDA) contains data which when submitted to FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.
The FDA can also grant Galderma an extra 5 years on top of the regular patent period, so the battle over Generic Oracea could indeed last a long time.
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