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Generated: April 25, 2019

DrugPatentWatch Database Preview

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 four 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
Applicant:Vifor Fresenius
Ingredient:sucroferric oxyhydroxide
Generic Entry Opportunity Date for 205109
Generic Entry Date for 205109*:
Constraining patent/regulatory exclusivity:

*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:RXDosage:TABLET, CHEWABLE;ORALStrength500MG
Approval Date:Nov 27, 2013TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Dec 19, 2019Product Flag?Substance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 23, 2030Product Flag?YSubstance Flag?Delist Request?

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