Question 1

Is there a generic for Acetylcysteine lysine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Acetylcysteine lysine?

Accepted Answer

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

Question 3

Does Acetylcysteine lysine have FDA marketing exclusivity?

Accepted Answer

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.

Question 4

What dosage forms of Acetylcysteine lysine are approved?

Accepted Answer

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

Acetylcysteine lysine

Brand (NDA) products · for solution

Marketing exclusivity (2)

Listed patents

Acetylcysteine lysine — frequently asked questions

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