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Generated: November 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 207145

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NDA 207145 describes XADAGO, which is a drug marketed by Us Worldmeds Llc and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the XADAGO profile page.

The generic ingredient in XADAGO is safinamide mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the safinamide mesylate profile page.
Summary for 207145
Tradename:XADAGO
Applicant:Us Worldmeds Llc
Ingredient:safinamide mesylate
Patents:3
Generic Entry Opportunity Date for 207145
Generic Entry Date for 207145*:
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.

Suppliers and Packaging for NDA: 207145
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XADAGO safinamide mesylate TABLET;ORAL 207145 NDA US WorldMeds, LLC 27505-110 27505-110-30 1 BOTTLE in 1 CARTON (27505-110-30) > 30 TABLET, FILM COATED in 1 BOTTLE
XADAGO safinamide mesylate TABLET;ORAL 207145 NDA US WorldMeds, LLC 27505-110 27505-110-90 1 BOTTLE in 1 CARTON (27505-110-90) > 90 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Mar 21, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 21, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Sign UpPatent Expiration:Dec 10, 2028Product Flag?YSubstance Flag?YDelist Request?
Patented Use:ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES
Patent:➤ Sign UpPatent Expiration:Jun 8, 2027Product Flag?Substance Flag?YDelist Request?
Patented Use:ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

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