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Last Updated: May 20, 2022

XADAGO Drug Patent 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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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
Zambon SpAPhase 2
Alain KaelinPhase 4
Clinical Trial Unit Ente Ospedaliero CantonalePhase 4

See all XADAGO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for XADAGO

US Patents and Regulatory Information for XADAGO

XADAGO is protected by three US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of XADAGO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting XADAGO

Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

Methods for treatment of parkinson's disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES

FDA Regulatory Exclusivity protecting XADAGO

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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

International Patents for XADAGO

When does loss-of-exclusivity occur for XADAGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 1510
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07263328
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0712936
Estimated Expiration: See Plans and Pricing

Canada

Patent: 53012
Estimated Expiration: See Plans and Pricing

China

Patent: 1472880
Estimated Expiration: See Plans and Pricing

Patent: 3284984
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0150136
Estimated Expiration: See Plans and Pricing

Patent: 0161456
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15951
Estimated Expiration: See Plans and Pricing

Patent: 18113
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 29524
Estimated Expiration: See Plans and Pricing

Patent: 74521
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 7123
Estimated Expiration: See Plans and Pricing

Patent: 5326
Estimated Expiration: See Plans and Pricing

Patent: 0970028
Estimated Expiration: See Plans and Pricing

Patent: 1101308
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 29524
Estimated Expiration: See Plans and Pricing

Patent: 74521
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 30245
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 30233
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5294
Estimated Expiration: See Plans and Pricing

Japan

Patent: 40476
Estimated Expiration: See Plans and Pricing

Patent: 95342
Estimated Expiration: See Plans and Pricing

Patent: 09541232
Estimated Expiration: See Plans and Pricing

Patent: 13139446
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 74521
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 2698
Estimated Expiration: See Plans and Pricing

Patent: 08015704
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2798
Estimated Expiration: See Plans and Pricing

Patent: 5737
Estimated Expiration: See Plans and Pricing

Norway

Patent: 2018
Estimated Expiration: See Plans and Pricing

Patent: 2644
Estimated Expiration: See Plans and Pricing

Patent: 090231
Estimated Expiration: See Plans and Pricing

Patent: 171916
Estimated Expiration: See Plans and Pricing

Poland

Patent: 29524
Estimated Expiration: See Plans and Pricing

Patent: 74521
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 29524
Estimated Expiration: See Plans and Pricing

Patent: 74521
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 824
Estimated Expiration: See Plans and Pricing

Patent: 464
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 29524
Estimated Expiration: See Plans and Pricing

Patent: 74521
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1410291
Estimated Expiration: See Plans and Pricing

Patent: 1491541
Estimated Expiration: See Plans and Pricing

Patent: 090021392
Estimated Expiration: See Plans and Pricing

Patent: 140027563
Estimated Expiration: See Plans and Pricing

Spain

Patent: 27437
Estimated Expiration: See Plans and Pricing

Patent: 02069
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 93700
Estimated Expiration: See Plans and Pricing

Patent: 12512
Estimated Expiration: See Plans and Pricing

Patent: 0815322
Estimated Expiration: See Plans and Pricing

Patent: 1313662
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering XADAGO around the world.

Country Patent Number Title Estimated Expiration
Israel 195294 תהליך לייצור ספינאמיד או רלפינאמיד ברמת טהור גבוהה, שימושם בהכנת תרופות ותכשירים רפואיים המכילים אותם (Process for producing high purity safinamide or ralfinamide, use thereof in the preparation of medicaments and pharmaceutical formulations containing them) See Plans and Pricing
Mexico 2008015704 PROCESO PARA LA PRODUCCION DE 2-[4-(3-Y 2-FLUORO BENCILOXI) BENCILAMINO]PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.) See Plans and Pricing
Japan 2009541232 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XADAGO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1613296 15C0054 France See Plans and Pricing PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296 CR 2015 00042 Denmark See Plans and Pricing PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226
1613296 C 2015 034 Romania See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Merck
Boehringer Ingelheim
McKesson
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.