The last we heard from Impax Laboratories was in late 2009 when they had filed an Abbreviated New Drug Application (ANDA 91-447) to produce a generic version of Oracea.
A recent filing in Delaware shows Galderma attempting to block the production of Generic Oracea by invoking the protection of Patent 7,749,532. Galderma claim that this patent, the so-called 532 Chang Patent, formally issued July 6, 2010 (after Oracea was released to the market) protects their intellectual property from generic copies.
Impax are following in the footsteps of Mylan Pharmaceuticals, and are hoping to show that this patent is invalid. Mylan are further along in their battle against Galderma, but no doubt Impax will also benefit from any decision that might enable the creation of generic Oracea.
Can Only Be Good News
This can only be good news for rosacea sufferers, especially those who cannot afford Oracea. The good news only eventuates if Impax are successful of course.
Even with full insurance cover, Oracea can be out of the reach of many.
Note that Oracea and Metrogel is available for FREE for low income no insurance.
Legal Filing
Galderma Laboratories Inc. et al. v. Impax Laboratories Inc
1:11-cv-00477; filed May 26, 2011 in the District Court of Delaware
• Plaintiffs: Galderma Laboratories Inc.; Galderma Laboratories LP; Supernus Pharmaceuticals Inc.
• Defendant: Impax Laboratories Inc.Infringement of U.S. Patent No. 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), licensed to Galderma, following a Paragraph IV certification as part of Impax’s filing of an ANDA to manufacture a generic version of Galderma’s Oracea® (doxycyline delayed release capsules, used to treat inflammatory lesions of rosacea).
