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.
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: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | 10GM | ||||
| Approval Date: | Feb 12, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 12, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS. | ||||||||
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