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Express Scripts
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Generated: May 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208010

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NDA 208010 describes RAYALDEE, which is a drug marketed by Opko Ireland Global and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the RAYALDEE profile page.

The generic ingredient in RAYALDEE is calcifediol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcifediol profile page.
Summary for 208010
Tradename:RAYALDEE
Applicant:Opko Ireland Global
Ingredient:calcifediol
Patents:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 208010
Ingredient-typeCholecalciferol
Medical Subject Heading (MeSH) Categories for 208010
Suppliers and Packaging for NDA: 208010
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010 NDA OPKO Pharmaceuticals LLC 70301-1001 N 70301-1001-1
RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010 NDA OPKO Pharmaceuticals LLC 70301-1001 N 70301-1001-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength0.03MG
Approval Date:Jun 17, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 17, 2019
Regulatory Exclusivity Use:NEW PRODUCT
Patent:➤ Sign UpPatent Expiration:Aug 22, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Apr 25, 2028Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D

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Chinese Patent Office
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