Details for New Drug Application (NDA): 208379
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NDA 208379 describes ZYPITAMAG, which is a drug marketed by Medicure and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the ZYPITAMAG profile page.
The generic ingredient in ZYPITAMAG is pitavastatin magnesium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pitavastatin magnesium profile page.
The generic ingredient in ZYPITAMAG is pitavastatin magnesium. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pitavastatin magnesium profile page.
Summary for 208379
| Tradename: | ZYPITAMAG |
| Applicant: | Medicure |
| Ingredient: | pitavastatin magnesium |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208379
Generic Entry Date for 208379*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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.
Pharmacology for NDA: 208379
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Suppliers and Packaging for NDA: 208379
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYPITAMAG | pitavastatin magnesium | TABLET;ORAL | 208379 | NDA | Medicure International Inc | 25208-201 | 25208-201-09 | 90 TABLET, FILM COATED in 1 BOTTLE (25208-201-09) |
| ZYPITAMAG | pitavastatin magnesium | TABLET;ORAL | 208379 | NDA | Medicure International Inc | 25208-201 | 25208-201-15 | 500 TABLET, FILM COATED in 1 BOTTLE (25208-201-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE | ||||
| Approval Date: | Jul 14, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 8,829,186 | Patent Expiration: | Jan 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE | ||||
| Approval Date: | Jul 14, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 8,829,186 | Patent Expiration: | Jan 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 4MG BASE | ||||
| Approval Date: | Jul 14, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 8,829,186 | Patent Expiration: | Jan 19, 2031 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
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