Assyro AI

FDA Orange Book · active-ingredient family

Acetylcysteine

Acetylcysteine is approved as 3 brand and 27 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:CETYLEV · NDA 207916

3

Brand (NDA)

27

Generics (ANDA)

6

Listed patents

1

Exclusivity periods

Brand (NDA) products · injectable, solution, tablet, effervescent

ProductApplicantApplicationTEApproved
CETYLEVRLD×2ARBOR PHARMS LLCNDA 207916—Jan 29, 2016
ACETADOTERLDCUMBERLAND PHARMSNDA 021539APJan 23, 2004
MUCOMYSTRLD×2APOTHECONNDA 013601—Approved Prior to Jan 1, 1982

Generic (ANDA) products (27)

ProductApplicantApplicationTEApproved
ACETYLCYSTEINE×2CONBA USAANDA 214177ANMar 14, 2025
ACETYLCYSTEINE×2SOMERSET THERAPS LLCANDA 219194ANFeb 12, 2025
ACETYLCYSTEINESOMERSET THERAPS LLCANDA 218397APJun 07, 2024
ACETYLCYSTEINEEXELA PHARMAANDA 205643—Nov 01, 2023
ACETYLCYSTEINEONESOURCE SPECIALTYANDA 217182APApr 19, 2023
ACETYLCYSTEINEREGCON HOLDINGSANDA 215620APFeb 23, 2022
ACETYLCYSTEINEGLENMARK PHARMSANDA 213693APFeb 03, 2022
ACETYLCYSTEINEEXELA PHARMAANDA 204797—Apr 15, 2021
ACETYLCYSTEINEZYDUS PHARMSANDA 208166APJul 20, 2018
ACETYLCYSTEINESAGENT PHARMS INCANDA 091684APOct 31, 2017
ACETYLCYSTEINEEUGIA PHARMAANDA 207358APFeb 29, 2016
ACETYLCYSTEINERISINGANDA 203173APMar 24, 2015
ACETYLCYSTEINEALVOGENANDA 204674ANFeb 11, 2014
ACETYLCYSTEINEFRESENIUS KABI USAANDA 200644APNov 07, 2012
ACETYLCYSTEINEALVOGENANDA 203853ANJun 21, 2012
ACETYLCYSTEINEAM REGENTANDA 072489ANJul 28, 1995
ACETYLCYSTEINEAM REGENTANDA 072547ANJul 28, 1995
ACETYLCYSTEINEHOSPIRAANDA 073664ANAug 30, 1994
ACETYLCYSTEINEHOSPIRAANDA 074037ANAug 30, 1994
ACETYLCYSTEINEROXANEANDA 072621—Sep 30, 1992
ACETYLCYSTEINEROXANEANDA 072622—Sep 30, 1992
ACETYLCYSTEINEROXANEANDA 072323—Apr 30, 1992
ACETYLCYSTEINEROXANEANDA 072324—Apr 30, 1992
ACETYLCYSTEINEHOSPIRAANDA 071364—May 01, 1989
ACETYLCYSTEINEHOSPIRAANDA 071365—May 01, 1989
MUCOSIL-10DEYANDA 070575—Oct 14, 1986
MUCOSIL-20DEYANDA 070576—Oct 14, 1986

Marketing exclusivity (1)

  • D-196New indication / change exclusivity (3 years)

    Nov 26, 2027

    in 1 yr 6 mo

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8148356May 21, 202629 d ago
Product
9327028Jul 21, 2031in 5 yr 2 mo
U-1839
8722738Apr 06, 2032in 5 yr 11 mo
U-1373
9561204May 08, 2032in 6 yr
U-1373
8747894May 08, 2032in 6 yr
ProductU-1373
9427421May 08, 2032in 6 yr
Product

Acetylcysteine — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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