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
Summary for XADAGO
International Patents: | 97 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 69 |
Clinical Trials: | 5 |
Patent Applications: | 823 |
Drug Prices: | Drug price information for XADAGO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for XADAGO |
What excipients (inactive ingredients) are in XADAGO? | XADAGO excipients list |
DailyMed Link: | XADAGO at DailyMed |


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
Sponsor | Phase |
---|---|
Zambon SpA | Phase 2 |
Alain Kaelin | Phase 4 |
Clinical Trial Unit Ente Ospedaliero Cantonale | Phase 4 |
Pharmacology for XADAGO
Drug Class | Monoamine Oxidase Type B Inhibitor |
Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Monoamine Oxidase-B Inhibitors |
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 |