Is there a generic for Acetylcysteine?

Yes. The FDA Orange Book lists 27 approved generic (ANDA) applications for Acetylcysteine, referencing the brand CETYLEV. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Acetylcysteine?

CETYLEV (NDA 207916, ARBOR PHARMS LLC) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Acetylcysteine?

The Orange Book lists 6 patents against Acetylcysteine products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Acetylcysteine have FDA marketing exclusivity?

Yes. The Orange Book records 1 marketing-exclusivity period for Acetylcysteine. 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 are approved?

Acetylcysteine is approved in the following dosage forms: injectable, solution, tablet, effervescent.

FDA Orange Book · active-ingredient family

Acetylcysteine

Acetylcysteine: 3 brands, 27 generics; first approved Oct 14, 1986; generic available.

Generic available1 exclusivity periodHas discontinued products

Generic status & protection

Generic available: 27 ANDA applications approved.

Earliest patent expiry May 21, 2026Latest exclusivity ends Nov 26, 2027

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

May 21, 2026

3 mo ago

Brand (NDA) products

Originator applications

CETYLEVRLD
ARBOR PHARMS LLCNDA 20791620162 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
500MG TABLET, EFFERVESCENT ORAL Discontinued —
2.5GM TABLET, EFFERVESCENT ORAL Discontinued —
ACETADOTERLDRS
CUMBERLAND PHARMSNDA 0215392004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
MUCOMYSTRLD
APOTHECONNDA 013601—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —
10% SOLUTION INHALATION, ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
500MG	TABLET, EFFERVESCENT	ORAL	Discontinued	—
2.5GM	TABLET, EFFERVESCENT	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—
10%	SOLUTION	INHALATION, ORAL	Discontinued	—

Generic (ANDA) products (27)

Abbreviated applications

ACETYLCYSTEINE
CONBA USAANDA 21417720252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Rx AN
20% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
SOMERSET THERAPS LLCANDA 21919420252 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Rx AN
20% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
SOMERSET THERAPS LLCANDA 2183972024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
EXELA PHARMAANDA 2056432023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
ONESOURCE SPECIALTYANDA 2171822023
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
REGCON HOLDINGSANDA 2156202022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
GLENMARK PHARMSANDA 2136932022
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
EXELA PHARMAANDA 2047972021
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Discontinued —
ACETYLCYSTEINE
ZYDUS PHARMSANDA 2081662018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
SAGENT PHARMS INCANDA 0916842017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
EUGIA PHARMAANDA 2073582016
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
RISINGANDA 2031732015
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
ALVOGENANDA 2046742014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
FRESENIUS KABI USAANDA 2006442012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
6GM/30ML (200MG/ML) INJECTABLE INTRAVENOUS Rx AP
ACETYLCYSTEINE
ALVOGENANDA 2038532012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINERS
AM REGENTANDA 0724891995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINERS
AM REGENTANDA 0725471995
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
HOSPIRAANDA 0736641994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
HOSPIRAANDA 0740371994
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Rx AN
ACETYLCYSTEINE
ROXANEANDA 0726211992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
ROXANEANDA 0726221992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
ROXANEANDA 0723231992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
ROXANEANDA 0723241992
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
HOSPIRAANDA 0713641989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Discontinued —
ACETYLCYSTEINE
HOSPIRAANDA 0713651989
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —
MUCOSIL-10
DEYANDA 0705751986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
10% SOLUTION INHALATION, ORAL Discontinued —
MUCOSIL-20
DEYANDA 0705761986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
20% SOLUTION INHALATION, ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Rx	AN
20%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Rx	AN
20%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
6GM/30ML (200MG/ML)	INJECTABLE	INTRAVENOUS	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Rx	AN

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
10%	SOLUTION	INHALATION, ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
20%	SOLUTION	INHALATION, ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Marketing exclusivity

Hatch-Waxman

D-196New indication / change exclusivity (3 years)
Nov 26, 2027
in 1 yr 4 mo

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8148356	May 21, 2026	3 mo ago	Product
9327028	Jul 21, 2031	in 5 yr	U-1839
8722738	Apr 06, 2032	in 5 yr 9 mo	U-1373
9561204	May 08, 2032	in 5 yr 10 mo	U-1373
8747894	May 08, 2032	in 5 yr 10 mo	ProductU-1373
9427421	May 08, 2032	in 5 yr 10 mo	Product

Approval history

FDA approval span

First approval

Oct 14, 1986

40 yr 5 mo ago

Most recent approval

Mar 14, 2025

1 yr 5 mo ago

Approvals span 1986–2025 across 30 FDA applications.

Brand (NDA) 310%

Generic (ANDA) 2790%

Acetylcysteine: 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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