You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Details for New Drug Application (NDA): 207145


✉ Email this page to a colleague

« Back to Dashboard


NDA 207145 describes XADAGO, which is a drug marketed by Mdd Us 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:Mdd Us
Ingredient:safinamide mesylate
Patents:3
Pharmacology for NDA: 207145
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 MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. 27505-110 27505-110-14 1 BLISTER PACK in 1 CARTON (27505-110-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK
XADAGO safinamide mesylate TABLET;ORAL 207145 NDA MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. 27505-110 27505-110-30 1 BOTTLE in 1 CARTON (27505-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 50MG BASE
Approval Date:Mar 21, 2017TE:RLD:Yes
Patent:⤷  Try a TrialPatent 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:⤷  Try a TrialPatent 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
Patent:⤷  Try a TrialPatent Expiration:Mar 21, 2031Product Flag?Substance Flag?Delist Request?
Patented Use:ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.