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NDA

IMIPRAMINE HYDROCHLORIDE | N011838 | NOVARTIS PHARMACEUTICALS 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

API Supply Chain2 active DMFs8 inactive

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

TAPI NL BVIMIPRAMINE HYDROCHLORIDE USP

DMF 19061972

LUPIN LTDIMIPRAMINE HYDROCHLORIDE USP

DMF 214382008

LUNDBECK PHARMACEUTICALS ITALY SPAInactiveIMIPRAMINE HYDROCHLORIDE

DMF 19131972

DELMAR CHEMICALS INCInactiveIMIPRAMINE HYDROCHLORIDE

DMF 21191973

IROPHARM LTDInactiveIMIPRAMINE HYDROCHLORIDE

DMF 65351986

ACF CHEMIEFARMA NVInactiveIMIPRAMINE HYDROCHLORIDE

DMF 67641987

SELOC AGInactiveIMIPRAMINE HYDROCHLORIDE

DMF 68061987

ARCHIMICA SPAInactiveIMIPRAMINE HYDROCHLORIDE

DMF 71901987

EGIS PHARMACEUTICALS PRIVATE LTDInactiveIMIPRAMINE HYDROCHLORIDE

DMF 79461989

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveIMIPRAMINE HYDROCHLORIDE USP

DMF 202982007

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

Products (1)

#002 — 12.5MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.