NALDEMEDINE TOSYLATE - Generic Drug Details

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-four patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for NALDEMEDINE TOSYLATE

International Patents:	74
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Patent Applications:	143
DailyMed Link:	NALDEMEDINE TOSYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for NALDEMEDINE TOSYLATE

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

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			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y

International Patents for NALDEMEDINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Taiwan	I311056
Australia	2015221439	Crystalline 6,7-unsaturated-7-carbamoyl morphinane derivative, and method for producing same
Brazil	PI0610343	composto derivado de morfinan substituìdo por 7-carbamoìla 6,7-insaturada, composição farmacêutica e uso do mesmo
Canada	2814195	DERIVE 6,7-INSATURATE-7-CARBAMOYL-MORPHINANE ET PROCEDE POUR LE PRODUIRE (CRYSTAL OF 6,7-UNSATURATED-7-CARBAMOYL MORPHINAN DERIVATIVE AND METHOD FOR PRODUCING THE SAME)
Japan	2012162527	CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE AND METHOD FOR PRODUCING THE SAME
Russian Federation	2403255	6,7-НЕНАСЫЩЕННОЕ 7-КАРБАМОИЛЗАМЕЩЕННОЕ ПРОИЗВОДНОЕ МОРФИНАНА (6,7-UNSATURATED 7-CARBAMOYL SUBSTITUTED MORPHINANDERIVATIVE)
Israel	225725	נגזרת גבישית 6,7 - רוויה -7 - מורפין קרבאמויל ושיטה לייצורה (Crystal of 6,7- unsaturated-7-carbamoyl morphinan derivative and method for producing the same)

Supplementary Protection Certificates for NALDEMEDINE TOSYLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	2019C/533	Belgium		PRODUCT NAME: NALMEDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN BIJZONDER HET TOSYLAATZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1291 20190220
1889848	132019000000093	Italy		PRODUCT NAME: NALDEMEDINA O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SALE TOSILATO(RIZMOIC - NALDEMEDINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1291, 20190220
1889848	122019000063	Germany		PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	1990036-4	Sweden		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
1889848	C201930045	Spain		PRODUCT NAME: NADELMEDINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
1889848	C 2019 033	Romania		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	CA 2019 00035	Denmark		PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220