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Last Updated: April 15, 2021

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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 Mdd Us 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.

DrugPatentWatch® Generic Entry Outlook for Xadago

Xadago was eligible for patent challenges on March 21, 2021.

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
International Patents:97
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 63
Clinical Trials: 4
Patent Applications: 730
Drug Prices: Drug price information for XADAGO
What excipients (inactive ingredients) are in XADAGO?XADAGO excipients list
DailyMed Link:XADAGO at DailyMed
Drug patent expirations by year for XADAGO
Drug Prices for XADAGO

See drug prices for XADAGO

DrugPatentWatch® Estimated 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
Clinical Trial Unit Ente Ospedaliero CantonalePhase 4
Alain KaelinPhase 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
Mdd Us XADAGO safinamide mesylate TABLET;ORAL 207145-001 Mar 21, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Mdd Us XADAGO safinamide mesylate TABLET;ORAL 207145-002 Mar 21, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Mdd Us 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 CA 2015 00042 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224
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 CR 2015 00042 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
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McKinsey
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.