Details for New Drug Application (NDA): 205109

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NDA 205109 describes VELPHORO, which is a drug marketed by Vifor Fresenius and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the VELPHORO profile page.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.

Summary for 205109

Tradename:	VELPHORO
Applicant:	Vifor Fresenius
Ingredient:	sucroferric oxyhydroxide
Patents:	2

Generic Entry Opportunity Date for 205109

Generic Entry Date for 205109^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up Dosage: TABLET, CHEWABLE;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.

Suppliers and Packaging for NDA: 205109

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VELPHORO	sucroferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109	NDA	Fresenius Medical Care North America	49230-645	49230-645-51	1 BOTTLE in 1 CARTON (49230-645-51) > 90 TABLET, CHEWABLE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, CHEWABLE;ORAL			Strength	500MG
Approval Date:	Nov 27, 2013	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Dec 19, 2018	Product Flag?		Substance Flag?	Y	Delist Request?
Patented Use:	CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS
Patent:	➤ Sign Up	Patent Expiration:	Jan 23, 2030	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS

Expired US Patents for NDA 205109

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Fresenius	VELPHORO	sucroferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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