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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211281


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NDA 211281 describes PIZENSY, which is a drug marketed by Braintree Labs and is included in one NDA. There is one patent protecting this drug. Additional details are available on the PIZENSY profile page.

The generic ingredient in PIZENSY is lactitol. There are four drug master file entries for this compound. Additional details are available on the lactitol profile page.
Summary for 211281
Tradename:PIZENSY
Applicant:Braintree Labs
Ingredient:lactitol
Patents:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 211281
Generic Entry Date for 211281*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY
Dosage:
FOR SOLUTION;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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrength10GM
Approval Date:Feb 12, 2020TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 12, 2025
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:⤷  Sign UpPatent Expiration:May 12, 2037Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

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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.