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Last Updated: March 19, 2024

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Benzyl alcohol - Generic Drug Details


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What are the generic drug sources for benzyl alcohol and what is the scope of patent protection?

Benzyl alcohol is the generic ingredient in one branded drug marketed by Shionogi Inc and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for benzyl alcohol.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for benzyl alcohol
Generic Entry Date for benzyl alcohol*:
Constraining patent/regulatory exclusivity:
Dosage:
LOTION;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for benzyl alcohol

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

SponsorPhase
Inotiv LaboratoriesPhase 4
MicroConstants, Inc.Phase 4
Concentrics ResearchPhase 4

See all benzyl alcohol clinical trials

Medical Subject Heading (MeSH) Categories for benzyl alcohol
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

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

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