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Last Updated: January 16, 2021

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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. There are five patents protecting this drug. Additional details are available on the VELPHORO profile page.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are four drug master file entries 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:	5

Generic Entry Opportunity Date for 205109

Generic Entry Date for 205109^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial 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.

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:	Start Trial	Patent Expiration:	Nov 26, 2034	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Nov 13, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	Start Trial	Patent Expiration:	Nov 13, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

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	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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.

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