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PIZENSY

NDA

LACTITOL | N211281 | BRAINTREE LABORATORIES INC

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

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Today

10806743

May. 12, 2037

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 1 recruiting, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Dabrafenib and/or Trametinib Rollover Study NCT03340506	Phase 4	Recruiting	Novartis Pharmaceuticals	100	2017-12-28 → 2032-12-28
Study to Allow Access to Imatinib for Patients Who Are on Imatinib Treatment in a Novartis-sponsored Study and Are Benefiting From the Treatment as Judged by the Investigator NCT01742299	Phase 4	Completed	Novartis Pharmaceuticals	155	2013-03-26 → 2026-04-20

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

INALCO SRLLACTITOL MONOHYDRATE

DMF 277652013

CULTOR FOOD SCIENCE INCInactiveLACTITOL MONOHYDRATE

DMF 139521998

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 18, 2021	SUPPL -1	View Letter (PDF)
Feb 13, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10GM

RLD

1 patent0 exclusivities▴

FOR SOLUTION;ORAL | Approved: Feb 12, 2020

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10806743	May 12, 2037	—	—	—		—