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NDA

DESIPRAMINE HYDROCHLORIDE | N013621 | SANOFI AVENTIS US LLC

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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF6 inactive

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

LUNDBECK PHARMACEUTICALS ITALY SPADESIPRAMINE HYDROCHLORIDE

DMF 33741978

FARCHEMIA SRLInactiveDESIPRAMINE HYDROCHLORIDE USP

DMF 53671984

IRISH FINE CHEMICALS LTDInactiveDESIPRAMINE HYDROCHLORIDE

DMF 66431986

ACF CHEMIEFARMA NVInactiveDESIPRAMINE HYDROCHLORIDE

DMF 66631986

ARCHIMICA SPAInactiveDESIPRAMINE HYDROCHLORIDE USP

DMF 72161987

FABBRICA ITALIANA SINTETICI SPAInactiveDESIPRAMINE HYDROCHLORIDE

DMF 74011988

PCASInactiveDESIPRAMINE HYDROCHLORIDE

DMF 104611993

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

Products (2)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

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