DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 205109
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 two patents protecting this drug. Additional details are available on the VELPHORO profile page.
The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sucroferric oxyhydroxide profile page.
The generic ingredient in VELPHORO is sucroferric oxyhydroxide. There are four drug master file entries for this compound. One supplier is listed 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: | 2 |
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.
Suppliers and Packaging for NDA: 205109
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VELPHORO | sucroferric 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 | 500MG | ||||
| Approval Date: | Nov 27, 2013 | TE: | RLD: | Yes | |||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Dec 19, 2019 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS | ||||||||
| Patent: | ➤ Try a Free Trial | Patent Expiration: | Jan 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS | ||||||||
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