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  1. pharmadog
  2. ›drugs
  3. ›Rayaldee
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calcifediol ER

Marketedupdated 3mo ago
by OPKO Pharmaceuticals LLC
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying calcifediol ER

  • phase2Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDIterminatedn=44
  • N/APharmacokinetics of Calcifediol and Cholecalciferolcompletedn=93
  • phase2Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19completedn=171
  • phase3Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiencycompletedn=674

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 2, 2027
171 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (16)

  • Mar 14, 2034formulationUS 10300078
  • Mar 14, 2034formulationUS 10357502
  • Mar 14, 2034formulationUS 11253528
  • Mar 14, 2034formulationUS 9861644
  • Sep 7, 2030formulationUS 118012534.1y
  • Aug 27, 2028method-of-use (U-1872)US 84263912.0y
  • Jul 19, 2028formulationUS 83614881.9y
  • Apr 25, 2028method-of-use (U-3815)US 111545091.7y
  • Apr 25, 2028method-of-use (U-1871)US 82071491.7y
  • Apr 25, 2028method-of-use (U-1873)US 87783731.7y
  • Apr 25, 2028method-of-use (U-1888)US 94088581.7y
  • Apr 25, 2028method-of-use (U-3814)US 94984861.7y
  • Apr 25, 2028formulationUS 99251471.7y
  • Feb 2, 2027formulationUS 10213442171d
  • Feb 2, 2027formulationUS 8906410171d
  • Feb 2, 2027method-of-use (U-2274)US 9943530171d

News(0)

no news has mentioned this drug yet

brand
Rayaldee
generic
calcifediol
indication
Secondary Hyperparathyroidism
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 6m ago
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