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MECLOMEN

NDA

MECLOFENAMATE SODIUM | N018006 | PARKE DAVIS DIV WARNER LAMBERT 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

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs5 inactive

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

WR GRACE AND COMECLOFENAMATE SODIUM USP

DMF 55841984

YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTDMECLOFENAMATE SODIUM

DMF 227952009

PROFARMACO SRLInactiveMECLOFENAMATE SODIUM

DMF 57411985

FINE CHEMICALS CORPInactiveMECLOFENAMATE SODIUM

DMF 62241986

CAMBREX PROFARMACO MILANO SRLInactiveMECLOFENAMATE SODIUM

DMF 68571987

QUIMICA SINTETICA SAInactiveMECLOFENAMATE SODIUM USP

DMF 68711987

WARNER LAMBERT COInactiveMECLOFENAMATE SODIUM

DMF 81441989

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

Products (2)

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#001 — EQ 50MG BASE

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

0 patents0 exclusivities▾

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