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 seven patent family members in thirty-four countries.
There are three drug master file entries for ferric oxyhydroxide. Nine suppliers are listed for this compound.
Summary for ferric oxyhydroxide
| International Patents: | 107 |
| US Patents: | 11 |
| Tradenames: | 8 |
| Applicants: | 6 |
| NDAs: | 8 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 15 |
| 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
| 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 | ||||
| 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 | 021135-002 | Mar 20, 2005 | RX | Yes | 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 | |||
| >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
| 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
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2018154635 | リン酸塩結合剤粒子を含む医薬組成物 (PHARMACEUTICAL COMPOSITION, COMPRISING PHOSPHATE BINDER PARTICLES) | ⤷ Try a Trial |
| Russian Federation | 2648760 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ОКСИГИДРОКСИД ЖЕЛЕЗА, СПОСОБ ЕЕ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ (PHARMACEUTICAL COMPOSITION COMPRISING IRON OXY-HYDROXIDE, METHOD OF PRODUCTION THEREOF AND USE) | ⤷ Try a Trial |
| China | 105764492 | 包含磷酸盐结合剂颗粒的药物组合物 (Pharmaceutical composition, comprising phosphate binder particles) | ⤷ Try a Trial |
| Tunisia | 2010000152 | PHARMACEUTICAL COMPOSITIONS | ⤷ Try a Trial |
| China | 112022822 | 药物组合物 (Pharmaceutical compositions) | ⤷ Try a Trial |
| Taiwan | I592159 | ⤷ 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.
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