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LUDIOMIL

NDA

MAPROTILINE HYDROCHLORIDE | N017543 | NOVARTIS PHARMACEUTICALS CORP

3 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 DMF2 inactive

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

OLON SPAMAPROTILINE HYDROCHLORIDE

DMF 70961987

BALENCO ENTERPRISES INCInactiveMAPROTILINE HYDROCHLORIDE USP

DMF 67301986

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveMAPROTILINE HYDROCHLORIDE

DMF 70181987

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

Products (3)

Sort:

#001 — 25MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 50MG

0 patents0 exclusivities▾

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

#003 — 75MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 30, 1982