Naldemedine tosylate - Generic Drug Details

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What are the generic sources for naldemedine tosylate and what is the scope of freedom to operate?

Naldemedine tosylate is the generic ingredient in one branded drug marketed by Bdsi and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naldemedine tosylate has seventy-three patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for naldemedine tosylate

International Patents:	73
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	165
DailyMed Link:	naldemedine tosylate at DailyMed

Pharmacology for naldemedine tosylate

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

US Patents and Regulatory Information for naldemedine tosylate

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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
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing	Y	Y		See Plans and Pricing
>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 naldemedine tosylate

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Country	Patent Number	Title	Estimated Expiration
Israel	243188	שיטה לייצור נגזרת גבישית 7, 6 רווייה - 7 - מורפין קרבאמויל ומלחים שלה (Method for producing 6,7-unsaturated-7-carbamoyl morphinane derivative and its salts)	See Plans and Pricing
Japan	WO2006126637	６，７−不飽和−７−カルバモイル置換モルヒナン誘導体	See Plans and Pricing
Taiwan	201350120	Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivative	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for naldemedine tosylate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	C 2019 033	Romania	See Plans and Pricing	PRODUCT NAME: NALDEMEDINA SAU O SARE SAU SOLVAT ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF NATIONAL AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
1889848	2019/038	Ireland	See Plans and Pricing	PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	300996	Netherlands	See Plans and Pricing	PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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