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Last Updated: September 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208010


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NDA 208010 describes RAYALDEE, which is a drug marketed by Eirgen and is included in one NDA. It is available from one supplier. There are thirteen 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:Eirgen
Ingredient:calcifediol
Patents:13
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 208010
Generic Entry Date for 208010*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 208010
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 70301-1001-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)
RAYALDEE calcifediol CAPSULE, EXTENDED RELEASE;ORAL 208010 NDA OPKO Pharmaceuticals LLC 70301-1001 70301-1001-2 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (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
Patent:⤷  Try it FreePatent Expiration:Feb 2, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Mar 14, 2034Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try it FreePatent Expiration:Mar 14, 2034Product Flag?YSubstance Flag?Delist Request?

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
McKesson
Harvard Business School
Baxter
Moodys

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.