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SANOREX

NDA

MAZINDOL | N017247 | NOVARTIS PHARMACEUTICALS CORP

2 strengths0 unique patents0 unique exclusivities

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
AAIPharma - Citizen Petition FDA-2007-P-0300 · 6 docket documents AAIPharma filed this citizen petition pursuant to 21 CFR 10.30 and 314.161, requesting that the FDA Commissioner determine whether Sanorex (mazindol) Tablets in 1 mg and 2 mg strengths (NDA 17-247), approved by Novartis, were voluntarily withdrawn from sale for reasons of safety or efficacy or inste	505(q)	2008-04-25	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

2 trials from ClinicalTrials.gov, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)NCT02808104	Phase 2	Completed	NLS Pharmaceutics	84	2016-08 → 2017-03-28
Mazindol for Cocaine Abuse - 2 NCT00000277	Phase 2	Completed	Yale University	—	1994-09 → 1999-08

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

Products (2)

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#001 — 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982