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PAMELOR

NDA

NORTRIPTYLINE HYDROCHLORIDE | N018012 | SPECGX LLC

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 Pamelor (2023)

Total Spending

$1.5M

Total Claims

427

Beneficiaries

Avg Cost/Unit

$40.26

Spending Trend

$1.9M(2019)→$1.9M(2020)→$1.8M(2021)→$1.7M(2022)→$1.5M(2023)

YoY Change:+2.4%

5yr CAGR:+0.7%

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

API Supply Chain3 active DMFs2 inactive

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

SIGMA ALDRICH IRELAND LTDNORTRIPTYLINE HYDROCHLORIDE

DMF 74141988

VASUDHA PHARMA CHEM LTDNORTRIPTYLINE HYDROCHLORIDE USP

DMF 319742017

RL FINE CHEM PVT LTDNORTRIPTYLINE HYDROCHLORIDE

DMF 332272018

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveNORTRIPTYLINE HYDROCHLORIDE

DMF 83881990

ZYDUS LIFESCIENCES LTDInactiveNORTRIPTYLINE HYDROCHLORIDE USP

DMF 213302008

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jul 29, 2014	SUPPL -31	View Letter (PDF)
Jul 11, 2014	SUPPL -30	View Letter (PDF)
Oct 29, 2012	SUPPL -29	View Letter (PDF)
Jul 24, 2007	SUPPL -27	View Letter (PDF)
Jan 13, 2005	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/5ML

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.