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Last Updated: June 4, 2023

Details for New Drug Application (NDA): 208854

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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
Ingredient:naldemedine tosylate
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208854
Generic Entry Date for 208854*:
Constraining patent/regulatory exclusivity:

*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 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: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 TrialPatent Expiration:May 13, 2033Product Flag?YSubstance Flag?YDelist Request?
Patent:⤷  Try a TrialPatent Expiration:Nov 11, 2031Product Flag?YSubstance Flag?YDelist Request?

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.