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® Litigation and Generic Entry Outlook for Xadago
A generic version of XADAGO was approved as safinamide mesylate by PRINSTON INC on April 25th, 2024.
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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: | 593 |
| 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 |
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 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | AB | RX | Yes | No | ⤷ 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
Patent: UN PROCEDIMIENTO PARA LA PRODUCCION DE 2-(4-(3- Y 2- FLUOROBENCILOXI) BENCILAMINO) PROPANAMIDAS CON ALTO GRADO DE PUREZA
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 07263328
Patent: Process for the production of 2- [4 - ( 3- and 2-fluorobenzyloxy) benzylamino] propan amides
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0712936
Patent: processo para a produção de 2-[4-(3- e 2-fluorbenziloxi)benzilamino]-propanamidas, base de schiff isolada, safinamida ou ralfinamida, uso e formulações contendo as mesmas
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 53012
Patent: PROCEDE DE PRODUCTION DE 2-[4-(3- ET 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDES (PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLU0R0BENZYL0XY) BENZYL AMIN0) PROPAN AMIDES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1472880
Patent: Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Estimated Expiration: ⤷ Sign Up
Patent: 3284984
Patent: Process for the production of 2-[4-(3- and 2-flu0r0benzyl0xy)benzylamin0]propanamides
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
Patent: СПОСОБ ПОЛУЧЕНИЯ 2-[4-(3- И 2-ФТОРБЕНЗИЛОКСИ)БЕНЗИЛАМИНО]ПРОПАНАМИДОВ (PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDES)
Estimated Expiration: ⤷ Sign Up
Patent: 5326
Patent: ПРИМЕНЕНИЕ САФИНАМИДА И РАЛФИНАМИДА ВЫСОКОЙ СТЕПЕНИ ЧИСТОТЫ ДЛЯ ЛЕЧЕНИЯ ЗАБОЛЕВАНИЙ И БОЛЕЗНЕННЫХ СОСТОЯНИЙ В УСЛОВИЯХ, НЕ ПРЕПЯТСТВУЮЩИХ АКТИВНОСТИ ЦИТОХРОМОВ СИСТЕМЫ CYP450 И НЕ ПРОЯВЛЯЮЩИХ БЛОКИРУЮЩИХ СВОЙСТВ В ОТНОШЕНИИ HERG КАНАЛА (USE OF HIGHLY PURE SAFINAMIDE AND RALFINAMIDE FOR TREATMENT OF DISEASES AND DISEASED STATES IN CONDITIONS THAT DO NOT SUPPRESS ACTIVITY OF CYP450 SYSTEM CYTOCHROMES AND DO NOT MANIFEST BLOCKING PROPERTIES IN RESPECT OF HERG CHANNEL)
Estimated Expiration: ⤷ Sign Up
Patent: 0970028
Patent: СПОСОБ ПОЛУЧЕНИЯ 2-[4-(3- И 2-ФТОРБЕНЗИЛОКСИ)БЕНЗИЛАМИНО]ПРОПАНАМИДОВ
Estimated Expiration: ⤷ Sign Up
Patent: 1101308
Patent: ПРИМЕНЕНИЕ РАЛФИНАМИДА ДЛЯ ЛЕЧЕНИЯ БИПОЛЯРНОГО РАССТРОЙСТВА
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 29524
Patent: PROCEDE DE PRODUCTION DE 2- [4 - ( 3- ET 2-FLUOROBENZYLOXY) BENZYLAMINO] PROPANAMIDES (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLUOROBENZYLOXY) BENZYLAMINO] PROPAN AMIDES)
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
Patent: PROCESS FOR THE PRODUCTION OF 2-[4-(3-AND 2-FLUOROBENZYLOXY) BENZYLAMINO] PROPANAMIDES
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 30233
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 5294
Patent: 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)
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
Patent: MANUFACTURING METHOD FOR 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDE
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 74521
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2698
Patent: PROCESO PARA LA PRODUCCION DE 2-[4-(3- Y 2-FLUOROBENCILOXI) BENCILAMINO] PROPANAMIDAS. (PROCESS FOR THE PRODUCTION OF 2- [4 - ( 3- AND 2-FLU0R0BENZYL0XY) BENZYLAMIN0] PROPAN AMIDES.)
Estimated Expiration: ⤷ Sign Up
Patent: 08015704
Patent: 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.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 2798
Patent: PROCESS FOR THE PRODUCTION OF SAFINAMIDE AND RALFINAMIDE
Estimated Expiration: ⤷ Sign Up
Patent: 5737
Patent: PROCESS FOR THE PRODUCTION OF SAFINAMIDE AND RALFINAMIDE
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
Patent: Fremgangsmåte for fremstilling av 2-[4-(3- og 2-fluorbenzyloksy)benzylamino]propanamider
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
Patent: 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)
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
Patent: PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO] PROPAN AMIDES
Estimated Expiration: ⤷ Sign Up
Patent: 140027563
Patent: PROCESS FOR THE PRODUCTION OF 2-??4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO??PROPAN AMIDES
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
Patent: Process for the production of 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides with high purity degree
Estimated Expiration: ⤷ Sign Up
Patent: 1313662
Patent: High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides
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 |
|---|---|---|---|
| Australia | 2007263328 | Process for the production of 2- [4 - ( 3- and 2-fluorobenzyloxy) benzylamino] propan amides | ⤷ Sign Up |
| Netherlands | 300752 | ⤷ Sign Up | |
| China | 1771030 | Methods for treatment of parkinson's disease | ⤷ Sign Up |
| Japan | 2009541232 | ⤷ 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 | 92782 | Luxembourg | ⤷ Sign Up | 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 |
| 1613296 | 46/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | 122015000058 | Germany | ⤷ Sign Up | PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | 132016000023012 | Italy | ⤷ Sign Up | PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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