BENZYL ALCOHOL - Generic Drug Details

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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 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.

Summary for BENZYL ALCOHOL

US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	5
Raw Ingredient (Bulk) Api Vendors:	221
Clinical Trials:	22
Patent Applications:	6,602
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 Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
Shionogi Inc	ULESFIA	benzyl alcohol	LOTION;TOPICAL	022129-001	Apr 9, 2009	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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