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Last Updated: April 29, 2024

FERRIC OXYHYDROXIDE - Generic Drug Details

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What are the generic sources for ferric oxyhydroxide and what is the scope of patent protection?

Ferric oxyhydroxide is the generic ingredient in eight branded drugs marketed by Am Regent, Sanofi Aventis Us, Allergan, New River, West-ward Pharms Int, and Vifor Fresenius, and is included in eight NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ferric oxyhydroxide has one hundred and nineteen patent family members in thirty-five countries.

There are three drug master file entries for ferric oxyhydroxide. Nine suppliers are listed for this compound.

Summary for FERRIC OXYHYDROXIDE

International Patents:	119
US Patents:	11
Tradenames:	8
Applicants:	6
NDAs:	8
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	17
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERRIC OXYHYDROXIDE
DailyMed Link:	FERRIC OXYHYDROXIDE at DailyMed

Pharmacology for FERRIC OXYHYDROXIDE

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

US Patents and Regulatory Information for FERRIC OXYHYDROXIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-005	Mar 29, 2013		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
West-ward Pharms Int	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE	ferric oxyhydroxide	INJECTABLE;INJECTION	078215-001	Mar 31, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sanofi Aventis Us	IRON DEXTRAN	ferric oxyhydroxide	INJECTABLE;INJECTION	010787-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-001	Nov 6, 2000		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
New River	PROFERDEX	ferric oxyhydroxide	INJECTABLE;INJECTION	017807-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FERRIC OXYHYDROXIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	DEXFERRUM	ferric oxyhydroxide	INJECTABLE;INJECTION	040024-001	Feb 23, 1996	⤷ Try a Trial	⤷ Try a Trial
Vifor Fresenius	VELPHORO	ferric oxyhydroxide	TABLET, CHEWABLE;ORAL	205109-001	Nov 27, 2013	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for FERRIC OXYHYDROXIDE

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1118496		⤷ Try a Trial
Japan	6538734		⤷ Try a Trial
European Patent Office	2222285	COMPOSITIONS PHARMACEUTIQUES (PHARMACEUTICAL COMPOSITIONS)	⤷ Try a Trial
Taiwan	I468167		⤷ Try a Trial
Poland	3143992		⤷ Try a Trial
Saudi Arabia	112340044	تركيب صيدلاني يشتمل على أكسي هيدروكسيد الحديد بحمولة عالية على شكل ملائم للإعطاء عن طريق الفم (Pharmaceutical compositions comprising iron oxyhydroxide in high loading in a form suitable for oral administration)	⤷ Try a Trial
Malaysia	156383	PHARMACEUTICAL COMPOSITIONS	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated 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.