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Last Updated: August 6, 2020

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XADAGO Drug Profile

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When do Xadago patents expire, and when can generic versions of Xadago launch?

Xadago is a drug marketed by Us Worldmeds Llc and is included in one NDA. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries.

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.

US ANDA Litigation and Generic Entry Outlook for Xadago

Xadago will be eligible for patent challenges on March 21, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 10, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for XADAGO
Drug patent expirations by year for XADAGO
Drug Prices for XADAGO

See drug prices for XADAGO

Generic Entry Opportunity Date for XADAGO
Generic Entry Date for XADAGO*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for XADAGO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Alain KaelinPhase 4
Clinical Trial Unit Ente Ospedaliero CantonalePhase 4
IRCCS San RaffaelePhase 4

See all XADAGO clinical trials

US Patents and Regulatory Information for XADAGO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Us Worldmeds Llc XADAGO safinamide mesylate TABLET;ORAL 207145-001 Mar 21, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Us Worldmeds Llc XADAGO safinamide mesylate TABLET;ORAL 207145-002 Mar 21, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Us Worldmeds Llc XADAGO safinamide mesylate TABLET;ORAL 207145-001 Mar 21, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for XADAGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 C 2015 034 Romania   Start Trial PRODUCT NAME: SAFINAMIDA; NATIONAL AUTHORISATION NUMBER: EU/1/14/984; DATE OF NATIONAL AUTHORISATION: 20150224; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/984; DATE OF FIRST AUTHORISATION IN EEA: 20150224
1613296 132016000023012 Italy   Start Trial PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296 92782 Luxembourg   Start Trial PRODUCT NAME: SAFINAMIDE A UTILISER EN COMBINAISON AVEC LEVODOPA/PDI, ET EVENTUELLEMENT AVEC D'AUTRES MEDICAMENTS PD , POUR LE TRAITEMENT DE LA MALADIE DE PARKINSON; FIRST REGISTRATION DATE: 20150224
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Boehringer Ingelheim
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Johnson and Johnson

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.