Last Updated: September 29, 2026

GLYCEROL Drug Patent Profile

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

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Which patents cover Glycerol, and what generic alternatives are available?

Glycerol is a drug marketed by Aurobindo Pharma, Esjay Pharma, Lupin, MSN, Navinta Llc, Ph Health, and Teva Pharms Inc. and is included in seven NDAs.

The generic ingredient in GLYCEROL is glycerol phenylbutyrate. There is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the glycerol phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Glycerol

A generic version of GLYCEROL was approved as glycerol phenylbutyrate by PH HEALTH on December 2^nd, 2021.

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Summary for GLYCEROL

US Patents:	0
Applicants:	7
NDAs:	7
DailyMed Link:	GLYCEROL at DailyMed

Drug patent expirations by year for GLYCEROL

US Patents and Regulatory Information for GLYCEROL

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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
Aurobindo Pharma	GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	220313-001	Apr 15, 2026	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Teva Pharms Inc	GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	218738-001	Apr 15, 2026	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Msn	GLYCEROL PHENYLBUTYRATE	glycerol phenylbutyrate	LIQUID;ORAL	219540-001	Apr 15, 2026	AA	RX	No	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

DrugChatter Q&A for GLYCEROL

Novartis glycerol dibehenate?

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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.