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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208379

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NDA 208379 describes ZYPITAMAG, which is a drug marketed by Zydus Pharms Usa Inc 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.
Summary for 208379
Tradename:ZYPITAMAG
Applicant:Zydus Pharms Usa Inc
Ingredient:pitavastatin magnesium
Patents:1
Formulation / Manufacturing:see details
Generic Entry Opportunity 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
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 25208-200 25208-200-09 90 TABLET, FILM COATED in 1 BOTTLE (25208-200-09)
ZYPITAMAG pitavastatin magnesium TABLET;ORAL 208379 NDA Medicure International Inc 25208-200 25208-200-10 1 BLISTER PACK in 1 CARTON (25208-200-10) > 7 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 1MG BASE
Approval Date:Jul 14, 2017TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 19, 2031Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2MG BASE
Approval Date:Jul 14, 2017TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 19, 2031Product Flag?YSubstance Flag?YDelist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 4MG BASE
Approval Date:Jul 14, 2017TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 19, 2031Product Flag?YSubstance Flag?YDelist Request?

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