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NARDIL

NDA

PHENELZINE SULFATE | N011909 | PARKE DAVIS DIV WARNER LAMBERT CO

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer NCT02217709	Phase 2	Completed	University of Southern California	26	2014-09-08 → 2020-06-29

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

Medicare Part D Spending

CMS annual spending data for Nardil (2023)

Total Spending

$116K

Total Claims

278

Beneficiaries

Avg Cost/Unit

$2.58

Spending Trend

$330K(2019)→$276K(2020)→$104K(2021)→$131K(2022)→$116K(2023)

YoY Change:+0.2%

5yr CAGR:+1.5%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs1 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

PROCOS SPAPHENELZINE SULFATE

DMF 43281981

SIEGFRIED EVIONNAZ SAPHENELZINE SULFATE

DMF 77901988

TYCHE INDUSTRIES LTDPHENELZINE SULFATE

DMF 313032017

CML EUROPE BVInactivePHENELZINE SULFATE

DMF 184002005

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Aug 7, 2007	SUPPL -38	View Letter (PDF)
Feb 12, 2007	SUPPL -36	View Letter (PDF)
Feb 23, 2005	SUPPL -35	View Letter (PDF)
Sep 9, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — EQ 15MG BASE

RLDAB

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.