Last Updated: September 27, 2026

BENZYL ALCOHOL - Generic Drug Details

Name: BENZYL ALCOHOL Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for benzyl alcohol and what is the scope of freedom to operate?

Benzyl alcohol is the generic ingredient in one branded drug marketed by Shionogi and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for BENZYL ALCOHOL

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	22
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BENZYL ALCOHOL
What excipients (inactive ingredients) are in BENZYL ALCOHOL?	BENZYL ALCOHOL excipients list
DailyMed Link:	BENZYL ALCOHOL at DailyMed

Recent Clinical Trials for BENZYL ALCOHOL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Medpace, Inc.	Phase 4
STATKING Clinical Services	Phase 4
Inotiv Laboratories	Phase 4

See all BENZYL ALCOHOL clinical trials

Medical Subject Heading (MeSH) Categories for BENZYL ALCOHOL

Anesthetics, Local

Anatomical Therapeutic Chemical (ATC) Classes for BENZYL ALCOHOL

P03AX	Other ectoparasiticides, incl. scabicides
P03A	ECTOPARASITICIDES, INCL. SCABICIDES
P03	ECTOPARASITICIDES, INCL. SCABICIDES, INSECTICIDES AND REPELLENTS
P	Antiparasitic products, insecticides and repellents

Paragraph IV (Patent) Challenges for BENZYL ALCOHOL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ULESFIA	Lotion	benzyl alcohol	5%	022129	1	2016-04-11

US Patents and Regulatory Information for BENZYL ALCOHOL

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shionogi	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BENZYL ALCOHOL

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shionogi	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Start Trial	⤷ Start Trial
Shionogi	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Start Trial	⤷ Start Trial
Shionogi	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Start Trial	⤷ Start Trial
Shionogi	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.