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AVENTYL HYDROCHLORIDE

NDA

NORTRIPTYLINE HYDROCHLORIDE | N014684 | ELI LILLY AND CO

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Procedural Framing and Epidural Steroid Injection Outcomes NCT07498140	N/A	Recruiting	Northwestern University	210	2026-03-30 → 2028-06-30

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

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.

Products (2)

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#001 — EQ 10MG BASE

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 25MG BASE

0 patents0 exclusivities▾

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