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FDA Orange Book · active-ingredient family

Acetaminophen

Acetaminophen is approved as 11 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACETAMINOPHEN · NDA 206968

11

Brand (NDA)

29

Generics (ANDA)

9

Listed patents

1

Exclusivity periods

Brand (NDA) products · injectable, powder, solution, suppository, tablet, extended release

ProductApplicantApplicationTEApproved
ACETAMINOPHENRLDHIKMANDA 206968—Jun 03, 2022
ACETAMINOPHENRLD×2B BRAUN MEDICALNDA 204957AP2Feb 18, 2021
ACETAMINOPHENRLDRISINGNDA 206610—Jan 15, 2021
OFIRMEVRLDMALLINCKRODT HOSPNDA 022450—Nov 02, 2010
TYLENOLRLD×2KENVUE BRANDSNDA 019872—Jun 08, 1994
ACETAMINOPHENRLD×4TARONDA 018337—Sep 12, 1983
ACETAMINOPHENFRESENIUS KABI USANDA 204767—Oct 28, 2015
INJECTAPAPORTHO MCNEIL PHARMNDA 017785—Mar 07, 1986
ACEPHEN×3COSETTENDA 018060—Approved Prior to Jan 1, 1982
NEOPAPPOLYMEDICANDA 016401—Approved Prior to Jan 1, 1982
TYLENOL×2J AND J CONSUMER INCNDA 017756—Approved Prior to Jan 1, 1982

Generic (ANDA) products (29)

ProductApplicantApplicationTEApproved
ACETAMINOPHENCAPLINANDA 219096AP1Dec 05, 2025
ACETAMINOPHEN×2GLANDANDA 219215APApr 02, 2025
ACETAMINOPHENINFORLIFEANDA 215403AP1May 03, 2023
ACETAMINOPHENAPOTEXANDA 205746AP1Apr 18, 2023
ACETAMINOPHENZYDUS PHARMSANDA 216467—Oct 25, 2022
ACETAMINOPHENASPIROANDA 216617AP1Jul 27, 2022
ACETAMINOPHEN×2BAXTER HLTHCARE CORPANDA 214331AP1Sep 17, 2021
ACETAMINOPHENMARKSANS PHARMAANDA 215486—Aug 25, 2021
ACETAMINOPHENEUGIA PHARMAANDA 210969AP1Oct 21, 2020
ACETAMINOPHENMYLANANDA 213255AP1Aug 07, 2020
ACETAMINOPHENGRANULESANDA 211544—Apr 16, 2019
ACETAMINOPHENHERITAGEANDA 207035—May 31, 2018
ACETAMINOPHENAUROBINDO PHARMAANDA 207229—Nov 09, 2016
ACETAMINOPHENHIKMAANDA 202605AP1Jun 13, 2016
ACETAMINOPHENSANDOZANDA 204052AP1Mar 22, 2016
ACETAMINOPHENSUN PHARM INDS LTDANDA 078569—Dec 14, 2011
ACETAMINOPHENSUN PHARM INDS LTDANDA 090205—Nov 18, 2009
ACETAMINOPHENOHM LABSANDA 076200—Mar 19, 2002
ACETAMINOPHENPERRIGOANDA 075077—Feb 25, 2000
ACETAMINOPHENABLEANDA 073106—Feb 27, 1995
ACETAMINOPHENABLEANDA 073107—Feb 27, 1995
ACETAMINOPHENABLEANDA 073108—Feb 27, 1995
ACEPHENCOSETTE PHARMS NCANDA 072218—Mar 27, 1992
ACEPHENCOSETTE PHARMS NCANDA 072344—Mar 27, 1992
ACEPHENCOSETTE PHARMS NCANDA 072237—Mar 27, 1992
ACETAMINOPHENACINO PRODSANDA 071010—May 12, 1987
ACETAMINOPHENACINO PRODSANDA 071011—May 12, 1987
ACETAMINOPHENPERRIGO NEW YORKANDA 070607—Apr 06, 1987
ACETAMINOPHENPERRIGO NEW YORKANDA 070608—Dec 01, 1986

Marketing exclusivity (1)

  • PCPatent-challenge (180-day generic) exclusivity

    Jan 07, 2026

    5 mo ago

Listed patents (9)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9987238Nov 13, 2028in 2 yr 5 mo
U-2261
10383834Nov 13, 2028in 2 yr 5 mo
U-2262
9610265Nov 13, 2028in 2 yr 5 mo
U-2263
9610265*PEDMay 13, 2029in 2 yr 11 mo
9987238*PEDMay 13, 2029in 2 yr 11 mo
10383834*PEDMay 13, 2029in 2 yr 11 mo
8741959Apr 19, 2030in 3 yr 11 mo
Product
9399012Sep 11, 2031in 5 yr 4 mo
U-2262
9399012*PEDMar 11, 2032in 5 yr 10 mo

Acetaminophen — frequently asked questions

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

Agent CTA Background

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