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Last Updated: November 2, 2024

Acetylcysteine lysine - Generic Drug Details


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What are the generic drug sources for acetylcysteine lysine and what is the scope of patent protection?

Acetylcysteine lysine is the generic ingredient in one branded drug marketed by Galephar and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for acetylcysteine lysine
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Clinical Trials: 1
Patent Applications: 190
DailyMed Link:acetylcysteine lysine at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for acetylcysteine lysine
Generic Entry Date for acetylcysteine lysine*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT
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.

Recent Clinical Trials for acetylcysteine lysine

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

SponsorPhase
Joel LavinePhase 1/Phase 2
Raptor Pharmaceuticals Corp.Phase 1/Phase 2

See all acetylcysteine lysine clinical trials

US Patents and Regulatory Information for acetylcysteine lysine

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 215040-001 Feb 13, 2024 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Galephar LEGUBETI acetylcysteine lysine FOR SOLUTION;ORAL 215040-002 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.