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
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	207145-001	Mar 21, 2017	AB	RX	Yes	No	⤷ 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	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
Aurobindo Pharma	SAFINAMIDE MESYLATE	safinamide mesylate	TABLET;ORAL	215902-001	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
Mdd Us	XADAGO	safinamide mesylate	TABLET;ORAL	207145-002	Mar 21, 2017	AB	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 SAFINAMIDE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
Poland	2474521		⤷ Sign Up
Australia	2007263328	Process for the production of 2- [4 - ( 3- and 2-fluorobenzyloxy) benzylamino] propan amides	⤷ Sign Up
Israel	216403	הרכב רוקחי בתצורה משולבת המכיל סאלפינאמיד ואגוניסט דופמין ושימוש בו (Pharmaceutical composition in combined form comprising salfinamide and a dopamine agonist and uses thereof)	⤷ Sign Up
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)	⤷ Sign Up
Hungary	E030233		⤷ Sign Up
Canada	2523188	PROCEDES DE TRAITEMENT DE LA MALADIE DE PARKINSON (METHODS FOR TREATMENT OF PARKINSON'S DISEASE)	⤷ Sign Up
Taiwan	201313662	High purity degree 2-[4-(3- and 2-fluorobenzyloxy)benzylamino]propanamides	⤷ 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	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	132016000023012	Italy	⤷ Sign Up	PRODUCT NAME: SAFINAMIDE(XADAGO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/984, 20150224
1613296	15C0054	France	⤷ Sign Up	PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 20150224
1613296	46/2015	Austria	⤷ Sign Up	PRODUCT NAME: SAFINAMIDE; REGISTRATION NO/DATE: EU/1/14/984 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	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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