Naldemedine tosylate - Generic Drug Details

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What are the generic drug sources for naldemedine tosylate and what is the scope of patent protection?

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-one patent family members in twenty-five countries.

One supplier is listed for this compound.

Summary for naldemedine tosylate

International Patents:	71
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	144
DailyMed Link:	naldemedine tosylate at DailyMed

Pharmacology for naldemedine tosylate

Drug Class	Opioid Antagonist
Mechanism of Action	Opioid Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for naldemedine tosylate

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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
European Patent Office	2639234	DÉRIVÉ 6,7-INSATURATÉ-7-CARBAMOYL-MORPHINANE ET PROCÉDÉ POUR LE PRODUIRE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME)	See Plans and Pricing
Denmark	2639234		See Plans and Pricing
European Patent Office	2851075	PRÉPARATION CONTENANT UN DÉRIVÉ DE 7-CARBAMOYLMORPHINANE 6,7-INSATURÉ (PREPARATION CONTAINING 6,7-UNSATURATED-7-CARBAMOYLMORPHINAN 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	CA 2019 00035	Denmark	See Plans and Pricing	PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848	19C1042	France	See Plans and Pricing	PRODUCT NAME: NALDEMEDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SOLVATES, EN PARTICULIER LE SEL DE TOSYLATE; REGISTRATION NO/DATE: EU/1/18/1291 20190220
1889848	38/2019	Austria	See Plans and Pricing	PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLATSALZ; REGISTRATION NO/DATE: EU/1/18/1291 (MITTEILUNG) 20190220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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