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ULESFIA

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Sicor Pharmaceuticals, Inc. - Attachment 2 - Propos... FDA-2006-P-0077 · 7 docket documents Sicor Pharmaceuticals, Inc. filed an ANDA suitability petition regarding Methotrexate Injection, USP, requesting approval for marketing an isotonic preservative formulation (25 mg/mL in 2 mL vials containing 50 mg methotrexate with benzyl alcohol as preservative) and a preservative-free formulation	Suitability	2008-11-17	Withdrawn	Sicor Pharmaceuticals, Inc. - Attachment 2 - Proposed Package Insert for PCH's Methotrexate Injection, USP

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

5 trials from ClinicalTrials.gov, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Safety and PK Study of Ha44 Gel Under Maximal Use Conditions for Treatment of Head Lice Infestation NCT01907490	Phase 2	Completed	Dr. Reddy's Laboratories Limited	38	2013-03 → 2013-12
Bioequivalence Study for Benzyl Alcohol Lotion 5%.NCT02624843	Phase 3	Completed	Akorn, Inc.	239	2015-08 → 2015-11
Study to Evaluate the Safety of a New Oxime, MMB4 DIMETHANESULFONATE (DMS)NCT02018250	Phase 1	Completed	U.S. Army Medical Research and Development Command	32	2012-03-17 → 2012-12
Comparison of Bacteriostatic Saline to Buffered Lidocaine for Ultrasound Guided Hip Joint Injection Local Anesthesia NCT02209272	Phase 4	Completed	Mayo Clinic	68	2014-08 → 2018-02
A Pediatric Safety and Pharmacokinetics Study of Ha44 Gel Administered Topically for Treatment of Head Lice Infestation NCT02010333	Phase 2	Completed	Dr. Reddy's Laboratories Limited	22	2013-04 → 2014-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

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.