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NDA

BENZYL ALCOHOL | N022129 | SHIONOGI INC

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Shionogi Inc. et al v. Actavis Laboratories UT, Inc. 1:2016cv00606 2 patentsANDA 209212Benzyl Alcohol	D. Del.	2016-07-14	Terminated 2017-03-21	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 DMF1 inactive

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

SIGMA ALDRICH IRELAND LTDBENZYL ALCOHOL

DMF 270172013

EMERALD KALAMA CHEMICAL LLCInactiveBENZYL ALCOHOL NF-API

DMF 200982006

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

LOTION;TOPICAL | Approved: Apr 9, 2009

No patent or exclusivity listings for this strength.