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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 one branded drug marketed by Mdd Us and is included in one NDA. 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.
There are two drug master file entries for safinamide mesylate. One supplier is listed for this compound.
Summary for safinamide mesylate
| International Patents: | 97 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 61 |
| Patent Applications: | 24 |
| DailyMed Link: | safinamide mesylate at DailyMed |
Pharmacology for safinamide mesylate
| Drug Class | Monoamine Oxidase Type B Inhibitor |
| Mechanism of Action | Monoamine Oxidase-B Inhibitors Breast Cancer Resistance Protein Inhibitors |
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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-001 | Mar 21, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Mdd Us | XADAGO | safinamide mesylate | TABLET;ORAL | 207145-002 | Mar 21, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Estimated Expiration |
|---|---|---|
| South Korea | 101129015 | Start Trial |
| Russian Federation | 2342929 | Start Trial |
| Lithuania | 2474521 | Start Trial |
| New Zealand | 595737 | Start Trial |
| Denmark | 2474521 | Start Trial |
| China | 102274517 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for safinamide mesylate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1613296 | 132016000023012 | Italy | Start Trial | PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224 |
| 1613296 | 15C0054 | France | Start Trial | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | 46/2015 | Austria | Start Trial | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | 300752 | Netherlands | Start Trial | PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224 |
| 1613296 | CA 2015 00042 | Denmark | Start Trial | PRODUCT NAME: KOMBINATION AF SAFINAMID OG LEVOPODA/PDI; REG. NO/DATE: EU/1/14/984/001-010 20150224 |
| 1613296 | 122015000058 | Germany | Start Trial | PRODUCT NAME: XADAGO; REGISTRATION NO/DATE: 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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