FDA Orange Book · active-ingredient family
Acetaminophen
Acetaminophen: 11 brands, 29 generics; first approved Sep 12, 1983; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 29 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
11
Generics (ANDA)
29
Listed patents
9
Next patent expiry
Nov 13, 2028
in 2 yr 4 mo
Brand (NDA) products
Originator applications
- ACETAMINOPHENRLDRSHIKMANDA 2069682022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - ACETAMINOPHENRLDRSB BRAUN MEDICALNDA 20495720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/50ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP2 - ACETAMINOPHENRLDRISINGNDA 2066102021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/VIAL POWDER INTRAVENOUS Discontinued — - OFIRMEVRLDMALLINCKRODT HOSPNDA 0224502010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Discontinued — - KENVUE BRANDSNDA 01987219942 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENRLDTARONDA 01833719834 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL Discontinued — 325MG SUPPOSITORY RECTAL OTC — 120MG SUPPOSITORY RECTAL OTC — 80MG SUPPOSITORY RECTAL OTC — - ACETAMINOPHENFRESENIUS KABI USANDA 2047672015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - ORTHO MCNEIL PHARMNDA 0177851986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/ML INJECTABLE INJECTION Discontinued — - COSETTENDA 018060—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL Discontinued — 650MG SUPPOSITORY RECTAL Discontinued — 325MG SUPPOSITORY RECTAL Discontinued — - POLYMEDICANDA 016401—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL Discontinued — - J AND J CONSUMER INCNDA 017756—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL Discontinued — 120MG SUPPOSITORY RECTAL Discontinued —
Generic (ANDA) products (29)
Abbreviated applications
- ACETAMINOPHENCAPLINANDA 2190962025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENGLANDANDA 21921520252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/50ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP2 - ACETAMINOPHENINFORLIFEANDA 2154032023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENAPOTEXANDA 2057462023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENZYDUS PHARMSANDA 2164672022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Discontinued — - ACETAMINOPHENASPIROANDA 2166172022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENBAXTER HLTHCARE CORPANDA 21433120212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 650MG/65ML (10MG/ML) SOLUTION INTRAVENOUS Rx — - ACETAMINOPHENMARKSANS PHARMAANDA 2154862021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENEUGIA PHARMAANDA 2109692020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENMYLANANDA 2132552020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENGRANULESANDA 2115442019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENHERITAGEANDA 2070352018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ACETAMINOPHENAUROBINDO PHARMAANDA 2072292016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENHIKMAANDA 2026052016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENRSSANDOZANDA 2040522016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM/100ML (10MG/ML) SOLUTION INTRAVENOUS Rx AP1 - ACETAMINOPHENSUN PHARM INDS LTDANDA 0785692011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ACETAMINOPHENSUN PHARM INDS LTDANDA 0902052009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL Discontinued — - ACETAMINOPHENOHM LABSANDA 0762002002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENPERRIGOANDA 0750772000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG TABLET, EXTENDED RELEASE ORAL OTC — - ACETAMINOPHENABLEANDA 0731061995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL Discontinued — - ACETAMINOPHENABLEANDA 0731071995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG SUPPOSITORY RECTAL Discontinued — - ACETAMINOPHENABLEANDA 0731081995
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL Discontinued — - COSETTE PHARMS NCANDA 0722181992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL Discontinued — - COSETTE PHARMS NCANDA 0723441992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 325MG SUPPOSITORY RECTAL Discontinued — - COSETTE PHARMS NCANDA 0722371992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL Discontinued — - ACETAMINOPHENACINO PRODSANDA 0710101987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL Discontinued — - ACETAMINOPHENACINO PRODSANDA 0710111987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL Discontinued — - ACETAMINOPHENPERRIGO NEW YORKANDA 0706071987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 120MG SUPPOSITORY RECTAL OTC — - ACETAMINOPHENPERRIGO NEW YORKANDA 0706081986
Approved strengths under this FDA application. Strength Dosage form Route Status TE 650MG SUPPOSITORY RECTAL OTC —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- PCPatent-challenge (180-day generic) exclusivity
7 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9987238 | in 2 yr 4 mo | U-2261 | |
| 10383834 | in 2 yr 4 mo | U-2262 | |
| 9610265 | in 2 yr 4 mo | U-2263 | |
| 9610265*PED | in 2 yr 10 mo | ||
| 9987238*PED | in 2 yr 10 mo | ||
| 10383834*PED | in 2 yr 10 mo | ||
| 8741959 | in 3 yr 9 mo | Product | |
| 9399012 | in 5 yr 2 mo | U-2262 | |
| 9399012*PED | in 5 yr 8 mo |
Approval history
FDA approval span
First approval
43 yr 6 mo ago
Most recent approval
8 mo ago
Approvals span 1983–2025 across 40 FDA applications.
Brand (NDA) 1128%
Generic (ANDA) 2973%
Acetaminophen: 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.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
