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Last Updated: November 2, 2024

LEGUBETI Drug Patent Profile


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When do Legubeti patents expire, and when can generic versions of Legubeti launch?

Legubeti is a drug marketed by Galephar and is included in one NDA.

The generic ingredient in LEGUBETI is acetylcysteine lysine. There are three drug master file entries for this compound. Additional details are available on the acetylcysteine lysine profile page.

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Summary for LEGUBETI
US Patents:0
Applicants:1
NDAs:1
Patent Applications: 122
DailyMed Link:LEGUBETI at DailyMed
Drug patent expirations by year for LEGUBETI
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LEGUBETI
Generic Entry Date for LEGUBETI*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
NDA:
Dosage:
FOR SOLUTION;ORAL

*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.

US Patents and Regulatory Information for LEGUBETI

LEGUBETI is protected by zero US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LEGUBETI is ⤷  Sign Up.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting LEGUBETI

NEW PRODUCT
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galephar LEGUBETI acetylcysteine lysine FOR SOLUTION;ORAL 215040-002 Feb 13, 2024 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galephar LEGUBETI acetylcysteine lysine FOR SOLUTION;ORAL 215040-001 Feb 13, 2024 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

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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.