Safinamide mesylate - Generic Drug Details
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What are the generic sources for safinamide mesylate and what is the scope of freedom to operate?
Safinamide mesylate
is the generic ingredient in two branded drugs marketed by Aurobindo Pharma and Mdd Us, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Safinamide mesylate has ninety-seven patent family members in thirty-one countries.
One supplier is listed for this compound.
Summary for safinamide mesylate
International Patents: | 97 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Patent Applications: | 68 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for safinamide mesylate |
What excipients (inactive ingredients) are in safinamide mesylate? | safinamide mesylate excipients list |
DailyMed Link: | safinamide mesylate at DailyMed |
Pharmacology for safinamide mesylate
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 safinamide mesylate
US Patents and Regulatory Information for safinamide mesylate
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 | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aurobindo Pharma | SAFINAMIDE MESYLATE | safinamide mesylate | TABLET;ORAL | 215902-001 | Jun 14, 2023 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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 safinamide mesylate
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) | ⤷ Try a Trial |
Norway | 335537 | ⤷ Try a Trial | |
Lithuania | 2474521 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for safinamide mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1613296 | 15C0054 | France | ⤷ Try a Trial | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
1613296 | C20150033 00258 | Estonia | ⤷ Try a Trial | PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015 |
1613296 | C 2015 034 | Romania | ⤷ Try a 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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