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 twenty-nine 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:	129
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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-002	Mar 20, 2005		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-001	Nov 6, 2000		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	VENOFER	ferric oxyhydroxide	INJECTABLE;INTRAVENOUS	021135-004	Feb 9, 2007		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
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

International Patents for ferric oxyhydroxide

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Country	Patent Number	Title	Estimated Expiration
Japan	2023011873		⤷ Sign Up
Taiwan	201509423	Pharmaceutical compositions	⤷ Sign Up
European Patent Office	3143992	COMPOSITIONS PHARMACEUTIQUES COMPRENNANT OXY-HYDROXIDE DE FER (PHARMACEUTICAL COMPOSITIONS COMPRISING IRON OXY-HYDROXIDE)	⤷ Sign Up
Hungary	E051111		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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