Details for New Drug Application (NDA): 208854

NDA 208854 describes SYMPROIC, which is a drug marketed by Bdsi and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SYMPROIC profile page.

The generic ingredient in SYMPROIC is naldemedine tosylate. One supplier is listed for this compound. Additional details are available on the naldemedine tosylate profile page.

Summary for 208854

Tradename:	SYMPROIC
Applicant:	Bdsi
Ingredient:	naldemedine tosylate
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208854

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 NDA: 208854

Mechanism of Action

Opioid Antagonists

Suppliers and Packaging for NDA: 208854

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854	NDA	BioDelivery Sciences International Inc	59385-041	59385-041-07	1 BLISTER PACK in 1 CARTON (59385-041-07) / 7 TABLET in 1 BLISTER PACK
SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854	NDA	BioDelivery Sciences International Inc	59385-041	59385-041-30	30 TABLET in 1 BOTTLE, PLASTIC (59385-041-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 0.2MG BASE
Approval Date:	Mar 23, 2017	TE:		RLD:	Yes
Patent:		Patent Expiration:	May 13, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Nov 11, 2031	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patent:		Patent Expiration:	Jan 11, 2028	Product Flag?	Y	Substance Flag?	Y	Delist Request?

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