- ROUNDTABLE: Improving patient outcomes, controlling costs with OTCs
- 21 health industry groups address FDA on proposed changes to generic drug label rules
- NACDS, NCPA, GPhA express support for Drug Quality and Security Act
- GPhA: FDA’s proposed rule on prescription drug labeling adds $4 billion to healthcare costs
- Study from NCPA sheds new light on med synchronization programs
THOUSAND OAKS, Calif. — Generic drug maker Teva Pharmaceutical Industries and subsidiary Barr Labs are prohibited from marketing a generic version of an Amgen drug for patients with chronic kidney disease until the drug’s patents expire, under a recent court decision.
Amgen announced that a U.S. District Court in Delaware ruled that the two companies would have to hold off launch of their version of Sensipar (cinacalcet) until 2018, when the last patent expires. The drug is used to treat secondary hyperparathyroidism in patients with CKD and elevated levels of calcium in patients with parathyroid carcinoma.
“We are pleased with the court’s ruling, which validates Amgen’s position that the Sensipar patents are valid, enforceable and infringed,” Amgen SVP, general counsel and secretary David Scott said. “Amgen will continue to vigorously defend its innovative products from infringement.”