Details for New Drug Application (NDA): 205109

✉ Email this page to a colleague

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

The generic ingredient in VELPHORO is ferric oxyhydroxide. There are twenty drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ferric oxyhydroxide profile page.

Summary for 205109

Tradename:	VELPHORO
Applicant:	Vifor Fresenius
Ingredient:	ferric oxyhydroxide
Patents:	11

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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.

Pharmacology for NDA: 205109

Mechanism of Action	Phosphate Chelating Activity

Suppliers and Packaging for NDA: 205109

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VELPHORO	ferric 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	EQ 500MG IRON
Approval Date:	Nov 27, 2013	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Jul 1, 2027
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Jan 1, 2028
Regulatory Exclusivity Use:	PEDIATRIC EXCLUSIVITY
Patent:	⤷ Sign Up	Patent Expiration:	May 26, 2035	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 205109

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vifor Fresenius	VELPHORO	ferric 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

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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.