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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cinacalcet
Trade Name: Sensipar
Date Designated: 04/30/2010
Orphan Designation: Treatment of hypercalcemia in patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo surgery
Orphan Designation Status: Designated/Approved
Amgen, Inc.
One Amgen Center Drive
Bldg 17, 1A-4-4, Mail Stop 17-1-B
Thousand Oaks, California 91320
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: cinacalcet
Trade Name: Sensipar
Marketing Approval Date: 02/25/2011
Approved Labeled Indication: Treatment of severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy
Exclusivity End Date: 02/25/2018 
Exclusivity Protected Indication* :  
2 Generic Name: cinacalcet
Trade Name: Sensipar
Marketing Approval Date: 11/21/2014
Approved Labeled Indication: Treatment of hypercalcemia in adult patients with primary hyperparathyroidism for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.
Exclusivity End Date: 11/21/2021 
Exclusivity Protected Indication* :  Treatment of less severe hypercalcemia (serum calcium >11.2 mg/dl and <= 12.5 mg/dl) in adult patients with primary hyperparathyroidism (HPT) for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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