Viewing data from:

PARNATE

NDA

TRANYLCYPROMINE SULFATE | N012342 | ADVANZ PHARMA (US) CORP

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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Parnate (2023)

Total Spending

$508K

Total Claims

252

Beneficiaries

Avg Cost/Unit

$9.05

Spending Trend

$726K(2019)→$668K(2020)→$642K(2021)→$607K(2022)→$508K(2023)

YoY Change:+4.2%

5yr CAGR:+6.1%

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

API Supply Chain2 active DMFs3 inactive

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

TRIFARMA SPATRANYLCYPROMINE SULFATE

DMF 165222003

NURAY CHEMICALS PRIVATE LTDTRANYLCYPROMINE SULFATE USP

DMF 268082013

SMITH KLINE & FRENCH LABS DIV SMITHKLINE BECKMAN CORPInactiveTRANYLCYPROMINE SULFATE

DMF 46801982

ALCHYMARS SPAInactiveTRANYLCYPROMINE SULFATE USP

DMF 71321987

LONZA RIVERSIDEInactiveTRANYLCYPROMINE SULFATE

DMF 103171993

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

Approval Letters

13 letters from Drugs@FDA

Date	Submission	Document
Jan 5, 2018	SUPPL -64	View Letter (PDF)
May 21, 2010	SUPPL -63	View Letter (PDF)
Aug 7, 2007	SUPPL -59	View Letter (PDF)
Jan 30, 2006	SUPPL -57	View Letter (PDF)
Jan 30, 2006	SUPPL -56	View Letter (PDF)
Jan 13, 2005	SUPPL -55	View Letter (PDF)
Mar 15, 2001	SUPPL -51	View Letter (PDF)
Mar 15, 2001	SUPPL -46	View Letter (PDF)
Mar 15, 2001	SUPPL -39	View Letter (PDF)
Mar 15, 2001	SUPPL -44	View Letter (PDF)
Mar 15, 2001	SUPPL -40	View Letter (PDF)
Mar 15, 2001	SUPPL -37	View Letter (PDF)
Mar 15, 2001	SUPPL -48	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#003 — EQ 10MG BASE

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 16, 1985

No patent or exclusivity listings for this strength.