Barr Pharmaceuticals confirmed that its subsidiary, Barr Laboratories, will go head to head with Amgen in a patent challenge process under the Hatch-Waxman Act.
Brigham and Women's Hospital, NPS Pharmaceuticals and Amgen took action to prevent Barr from marketing a generic version of the Sensipar tablets--which come in 30-, 60- and 90-mg tablets aimed at treating hyperparathyroidism--by filing suit in the U.S. District Court for the District of Delaware on Friday. The medication brought in well over $350 million in sales over the last year.
When people have hyperparathyroidism, their parathyroid glands (which are adjacent to the thyroid gland) produce too much parathyroid hormone, causing difficulties with calcium regulation.
Barr put in an Abbreviated New Drug Application (ANDA) with a paragraph IV certification request for a generic version of the drug with the FDA in March. The FDA deemed the application acceptable, but has not made a decision thus far.