Amneal Pharmaceuticals joins the Generic Oracea War

Written by on November 14, 2011 in Oracea (40mg doxycycline), patents with 0 Comments


News today of yet another company in the courts fighting against Galderma for the right to make Generic Oracea.

Amneal Pharmaceuticals, based in Gujarat, India, a producer of generic pharmaceuticals, has submitted an Abbreviated New Drug Application to the FDA. By doing so, Amneal Pharmaecuticals are seeking permission to market delayed release doxycycline 40mg for oral administration in the treatment of rosacea.

Galderma is claiming that the three patents 7,749,532, 7,232,572 and 7,211,267 protect it from competing manufacturers of Oracea.

It is War Out There!

Amneal now joins Mylan Pharmaceuticals, Impax and Lupin in a quest to crack their share of the lucrative Oracea market – thought to be as much as $260m for 2011.

Haven’t We Been Here Before?

We know from the dispute between Mylan Pharmaceuticals and Galderma that only the U.S. Patent No. 7,749,532, the so-called Chang Patent ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), is a valid patent held that my protect Galderma from generics.

Is this more Bad News?

As I said back in August, I fear that worst possible outcome for rosacea sufferers believing that Oracea is too expensive, will be a ruling that the patent protecting Oracea won’t expire until 2027.

Amneal joining the fight is really only a good sign if Mylan is able to negotiate a deal with Galderma in the favor of rosacea sufferers.

Court Report

Patent Docs: Court Report

Galderma Laboratories Inc. et al.v. Amneal Pharmaceuticals LLC et al.
Filed November 8, 2011 in the District Court of Delaware

  • Plaintiffs:  Galderma Laboratories Inc.; Galderma Laboratories LP; Supernus Pharmaceuticals Inc.
  • Defendants:  Amneal Pharmaceuticals LLC; Amneal Pharmaceuticals Co (I) Pvt Ltd.

Infringement of U.S. Patent Nos. 7,749,532 ("Once Daily Formulation of Tetracyclines," issued July 6, 2010), 7,232,572 ("Methods of Treating Rosacea," issued June 19, 2007), and 7,211,267 ("Methods of Treating Acne" issued May 1, 2007) following a Paragraph IV certification as part of Amneal’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).

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About the Author: David Pascoe started the Rosacea Support Group in October 1998. .

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