Viewing data from:

LORELCO

NDA

PROBUCOL | N017535 | 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 DMF5 inactive

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

SCI PHARMTECH INCPROBUCOL

DMF 173552004

HOECHST MARION ROUSSEL INCInactivePROBUCOL (DH-581)

DMF 21671973

MEDICHEM SAInactivePROBUCOL

DMF 75791988

SUMIKA FINE CHEMICALS CO LTDInactivePROBUCOL

DMF 77611988

WYCKOFF CHEMICAL CO INCInactivePROBUCOL

DMF 82581989

ZAMBON SPAInactivePROBUCOL USP

DMF 82861989

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

Products (2)

Sort:

#001 — 250MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 500MG

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 6, 1988