Is there a generic for Acetylcysteine lysine?

The FDA Orange Book does not currently list an approved generic (ANDA) for Acetylcysteine lysine. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Acetylcysteine lysine?

LEGUBETI (NDA 215040, GALEPHAR) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

Does Acetylcysteine lysine have FDA marketing exclusivity?

Yes. The Orange Book records 2 marketing-exclusivity periods for Acetylcysteine lysine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Acetylcysteine lysine are approved?

Acetylcysteine lysine is approved in the following dosage form: for solution.

FDA Orange Book · active-ingredient family

Acetylcysteine lysine

Acetylcysteine lysine: 1 brand, 0 generics; first approved Feb 13, 2024.

Brand only2 exclusivity periodsHas discontinued products

Generic status & protection

Marketing exclusivity runs through Feb 13, 2027.

Latest exclusivity ends Feb 13, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Brand (NDA) products

Originator applications

LEGUBETIRLD
GALEPHARNDA 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 —

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

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

NPNew product exclusivity (3 years)
Feb 13, 2027
in 6 mo
NPNew product exclusivity (3 years)
Feb 13, 2027
in 6 mo

Listed patents

Orange Book patent file

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

FDA approval span

First approval

Feb 13, 2024

2 yr 7 mo ago

Most recent approval

Feb 13, 2024

2 yr 7 mo ago

All 1 application were approved in 2024.

Brand (NDA) 1100%

Generic (ANDA) 00%

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.

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