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 sixteen 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:	16

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208010

Generic Entry Date for 208010^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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

Bone Density Conservation Agents
Vitamins

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:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	0.03MG
Approval Date:	Jun 17, 2016	TE:		RLD:	Yes
Patent:	⤷ Subscribe	Patent Expiration:	Feb 2, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Mar 14, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Subscribe	Patent Expiration:	Mar 14, 2034	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 208010

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eirgen	RAYALDEE	calcifediol	CAPSULE, EXTENDED RELEASE;ORAL	208010-001	Jun 17, 2016	⤷ Subscribe	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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