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Generated: November 13, 2018

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Details for New Drug Application (NDA): 208854

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NDA 208854 describes SYMPROIC, which is a drug marketed by Shionogi Inc and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the SYMPROIC profile page.

The generic ingredient in SYMPROIC is naldemedine tosylate. Two suppliers are listed for this compound. Additional details are available on the naldemedine tosylate profile page.
Summary for 208854
Tradename:SYMPROIC
Applicant:Shionogi Inc
Ingredient:naldemedine tosylate
Patents:3
Generic Entry Opportunity Date for 208854
Generic Entry Date for 208854*:
Constraining patent/regulatory exclusivity:
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 ActionOpioid 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 Purdue Pharma LP 59011-523 59011-523-07 1 BLISTER PACK in 1 CAPSULE (59011-523-07) > 7 TABLET in 1 BLISTER PACK
SYMPROIC naldemedine tosylate TABLET;ORAL 208854 NDA Purdue Pharma LP 59011-523 59011-523-30 30 TABLET in 1 BOTTLE (59011-523-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 0.2MG BASE
Approval Date:Mar 23, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 23, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Nov 11, 2031Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Try a Free TrialPatent Expiration:Jan 11, 2028Product Flag?YSubstance Flag?YDelist Request?

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