SAFINAMIDE MESYLATE - Generic Drug Details

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What are the generic sources for safinamide mesylate and what is the scope of patent protection?

Safinamide mesylate is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Prinston Inc, and Mdd Us, and is included in three 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:	3
NDAs:	3
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

N04BD	Monoamine oxidase B inhibitors
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

US Patents and Regulatory Information for SAFINAMIDE MESYLATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-002	Apr 25, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ 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
Aurobindo Pharma	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215902-002	Jun 14, 2023		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Prinston Inc	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215739-001	Apr 25, 2024	AB	RX	No	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 SAFINAMIDE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
South Korea	20110070929	METHODS FOR TREATMENT OF PARKINSON'S DISEASE	⤷ Sign Up
China	101472880	Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides	⤷ Sign Up
Norway	20171916	Fremgangsmåte for fremstilling av 2-[4-(3- og 2-fluorbenzyloksy)benzylamino]propanamider	⤷ Sign Up
Portugal	1613296		⤷ Sign Up
South Korea	101410291		⤷ Sign Up
Slovenia	1613296		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SAFINAMIDE MESYLATE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1613296	132016000023012	Italy	⤷ Sign Up	PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296	241 50017-2015	Slovakia	⤷ Sign Up	PRODUCT NAME: SAFINAMID; REGISTRATION NO/DATE: EU/1/14/984/001 - EU/1/14/984/010 20150226
1613296	C20150033 00258	Estonia	⤷ Sign Up	PRODUCT NAME: SAFINAMIID;REG NO/DATE: EU/1/14/984 26.02.2015
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	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	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
>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.