Acetylcysteine lysine
Acetylcysteine lysine: 1 brand, 0 generics; first approved Feb 13, 2024.
Marketing exclusivity runs through Feb 13, 2027.
Brand (NDA) products
- LEGUBETIRLDGALEPHARNDA 21504020242 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE/PACKET FOR SOLUTION ORAL Discontinued - EQ 2.5GM BASE/PACKET FOR SOLUTION ORAL Discontinued -
Patent & exclusivity timeline
Marketing exclusivity
- NPNew product exclusivity (3 years)
in 4 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
All 1 application were approved in 2024.
Acetylcysteine lysine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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