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Details for New Drug Application (NDA): 205109
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The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are four drug master file entries for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.
Summary for 205109
Tradename: | VELPHORO |
Applicant: | Vifor Fresenius |
Ingredient: | sucroferric oxyhydroxide |
Patents: | 5 |
Generic Entry Opportunity Date for 205109
Generic Entry Date for 205109*:
Constraining patent/regulatory exclusivity:
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.
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 500MG | ||||
Approval Date: | Nov 27, 2013 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | Nov 26, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Nov 13, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | Start Trial | Patent Expiration: | Nov 13, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 205109
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Vifor Fresenius | VELPHORO | sucroferric oxyhydroxide | TABLET, CHEWABLE;ORAL | 205109-001 | Nov 27, 2013 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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