XADAGO Drug Patent Profile
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When do Xadago patents expire, and what generic alternatives are available?
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.
There have been three patent litigation cases 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: | 156 |
Clinical Trials: | 5 |
Patent Applications: | 682 |
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 |
Recent Clinical Trials for XADAGO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Zambon SpA | Phase 2 |
Clinical Trial Unit Ente Ospedaliero Cantonale | Phase 4 |
Alain Kaelin | 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.
Patents protecting XADAGO
Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ADJUNCTIVE TREATMENT TO LEVODOPA/CARBIDOPA IN PATIENTS WITH PARKINSON'S DISEASE EXPERIENCING 'OFF' EPISODES
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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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: ⤷ Sign Up
Australia
Patent: 07263328
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0712936
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 53012
Estimated Expiration: ⤷ Sign Up
China
Patent: 1472880
Estimated Expiration: ⤷ Sign Up
Patent: 3284984
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0150136
Estimated Expiration: ⤷ Sign Up
Patent: 0161456
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 15951
Estimated Expiration: ⤷ Sign Up
Patent: 18113
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 29524
Estimated Expiration: ⤷ Sign Up
Patent: 74521
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 7123
Estimated Expiration: ⤷ Sign Up
Patent: 5326
Estimated Expiration: ⤷ Sign Up
Patent: 0970028
Estimated Expiration: ⤷ Sign Up
Patent: 1101308
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 29524
Estimated Expiration: ⤷ Sign Up
Patent: 74521
Patent: 2-[4-(3- et 2-fluorobenzyloxy)benzylamino]propanamides haute pureté pour une utilisation en tant que médicaments et compositions pharmaceutiques les contenant (High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides for use as medicaments and pharmaceutical formulations containing them)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 30245
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30233
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5294
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 40476
Estimated Expiration: ⤷ Sign Up
Patent: 95342
Estimated Expiration: ⤷ Sign Up
Patent: 09541232
Estimated Expiration: ⤷ Sign Up
Patent: 13139446
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 74521
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2698
Estimated Expiration: ⤷ Sign Up
Patent: 08015704
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2798
Estimated Expiration: ⤷ Sign Up
Patent: 5737
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 2018
Estimated Expiration: ⤷ Sign Up
Patent: 2644
Estimated Expiration: ⤷ Sign Up
Patent: 090231
Estimated Expiration: ⤷ Sign Up
Patent: 171916
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 29524
Estimated Expiration: ⤷ Sign Up
Patent: 74521
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 29524
Estimated Expiration: ⤷ Sign Up
Patent: 74521
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 824
Estimated Expiration: ⤷ Sign Up
Patent: 464
Patent: 2-[4-(3- I 2 FLUORBENZILOKSI) BENZILAMINO] PROPANAMIDI VISOKOG STEPENA ČISTOĆE ZA UPOTREBU KAO LEKOVI I FARMACEUTSKI PREPARATI KOJI IH SADRŽE (HIGH PURITY DEGREE 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDES FOR USE AS MEDICAMENTS AND PHARMACEUTICAL FORMULATIONS CONTAINING THEM)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 29524
Estimated Expiration: ⤷ Sign Up
Patent: 74521
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1410291
Estimated Expiration: ⤷ Sign Up
Patent: 1491541
Estimated Expiration: ⤷ Sign Up
Patent: 090021392
Estimated Expiration: ⤷ Sign Up
Patent: 140027563
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 27437
Estimated Expiration: ⤷ Sign Up
Patent: 02069
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 93700
Estimated Expiration: ⤷ Sign Up
Patent: 12512
Estimated Expiration: ⤷ Sign Up
Patent: 0815322
Estimated Expiration: ⤷ Sign Up
Patent: 1313662
Estimated Expiration: ⤷ Sign Up
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 |
---|---|---|---|
Mexico | PA05010873 | METODOS PARA EL TRATAMIENTO DE ENFERMEDAD DE PARKINSON. (METHODS FOR TREATMENT OF PARKINSON'S DISEASE.) | ⤷ Sign Up |
European Patent Office | 2474521 | 2-[4-(3- et 2-fluorobenzyloxy)benzylamino]propanamides haute pureté pour une utilisation en tant que médicaments et compositions pharmaceutiques les contenant (High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides for use as medicaments and pharmaceutical formulations containing them) | ⤷ Sign Up |
Taiwan | 200815322 | Process for the production of 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides with high purity degree | ⤷ Sign Up |
New Zealand | 542910 | Use of safinamide and levodopa for making a medicament for treatment of Parkinson's disease | ⤷ Sign Up |
Serbia | 53824 | PROCES ZA DOBIJANJE 2-[4-(3-I 2-FLUORBENZILOKSI) BENZILAMINO] PROPANAMIDA (PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLUOROBENZYLOXY) BENZYLAMINO] PROPAN AMIDES) | ⤷ Sign Up |
Japan | 5240476 | ⤷ Sign Up | |
Norway | 342644 | ⤷ Sign Up | |
>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 | ⤷ Sign Up | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
1613296 | 300752 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
1613296 | CA 2015 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224 |
1613296 | C 2015 034 | Romania | ⤷ Sign Up | 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 | ⤷ Sign Up | PRODUCT NAME: KOMBINATION AF SAFINAMID, HERUNDER SAFINAMID METHANSULFONAT, OG LEVODOPA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150226 |
1613296 | C20150033 00258 | Estonia | ⤷ Sign Up | PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015 |
1613296 | 241 50017-2015 | Slovakia | ⤷ Sign Up | PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |