Viewing data from:

ACETAMINOPHEN

NDA

ACETAMINOPHEN | N018337 | TARO PHARMACEUTICAL INDUSTRIES LTD

4 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

500 trials from ClinicalTrials.gov — 36 recruiting, 14 active, 353 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Post-cesarean Analgesia: Comparing Effectiveness of Staggered v. Simultaneous Therapies NCT07102641	Phase 4	Active	Thomas Jefferson University	825	2025-08-26 → 2027-12
Randomized Phase II Trial of Rituximab With Either Pentostatin or Bendamustine for Multiply Relapsed or Refractory Hairy Cell Leukemia NCT01059786	Phase 2	Active	National Cancer Institute (NCI)	69	2010-07-01 → 2031-06-30
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT NCT00840853	Phase 1	Active	Baylor College of Medicine	68	2009-04 → 2031-04
Multimodal Analgesia Effect on Post Surgical Patient NCT04240626	Phase 4	Active	University of California, Davis	60	2021-01-20 → 2026-06-24
Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma NCT04270409	Phase 3	Active	Sanofi	337	2020-06-16 → 2033-10-21
A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy NCT04629248	Phase 3	Active	Hoffmann-La Roche	142	2021-06-25 → 2027-12-21
CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs NCT06565546	N/A	Active	University of Florida	100	2025-01-29 → 2026-10
A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma NCT04268498	Phase 2	Active	University of Miami	310	2020-02-11 → 2027-02-01
Maxigesic for Postoperative Pain Control After Laparoscopic or Robotic Gastrectomy NCT07768514	Phase 2	Active	Seoul National University Bundang Hospital	90	2025-11-21 → 2026-12-25
Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)NCT06305754	Phase 3	Active	Merck Sharp & Dohme LLC	551	2024-06-11 → 2030-06-14

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs

Highest NADAC/Unit

$0.9607

per ea

Lowest NADAC/Unit

$0.9129

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51672211602FEVERALL 325 MG SUPPOSITORY	$0.9607	EA	Brand	—	2026-08-19
51672211502FEVERALL 120 MG SUPPOSITORY	$0.9276	EA	Brand	$0.2442	2026-08-19
51672211402FEVERALL 80 MG SUPPOSITORY	$0.9129	EA	Brand	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain24 active DMFs34 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

SPECGX LLCACETAMINOPHEN USP

DMF 53261984

ATABAY KIMYA SANAYI VE TICARET ASACETAMINOPHEN

DMF 62671986

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN USP

DMF 158462002

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 162102002

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN USP

DMF 173432004

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN GRANULES DC 90% (KRISOPAP 90F)

DMF 174412004

SRI KRISHNA PHARMACEUTICALS LTDACETAMINOPHEN GRANULES DC 90%

DMF 176062004

RHODIA ORGANIQUEACETAMINOPHEN USP

DMF 179132004

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90 3

DMF 191492006

GRANULES INDIA LTDACETAMINOPHEN USP

DMF 198042006

ANQUI LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90-3 SD

DMF 248872011

SHENZHOU JIHENG PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 262472012

HEBEI JIHENG GROUP PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90%

DMF 262482012

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDACETAMINOPHEN DC90

DMF 263422012

MEGHMANI LLPACETAMINOPHEN, USP

DMF 270982013

MEGHMANI LLPACETAMINOPHEN USP

DMF 302442016

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC90-7SD

DMF 316322017

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC90-10 SD

DMF 343372019

FARMSON BASIC DRUGS PRIVATE LTDACETAMINOPHEN USP

DMF 352402021

ANQIU LUAN PHARMACEUTICAL CO LTDACETAMINOPHEN DC 90-9

DMF 366932022

APITORIA PHARMA PRIVATE LTDACETAMINOPHEN USP

DMF 368142022

IOL CHEMICALS AND PHARMACEUTICALS LTDACETAMINOPHEN USP (PARACETAMOL USP)

DMF 373362022

HEBEI JIHENG PHARMACEUTICAL CO LTDACETAMINOPHEN

DMF 377092022

MEGHMANI LLPACETAMINOPHEN USP

DMF 410592025

RHONE POULENC RORER PHARMACEUTICALS INCInactiveACETAMINOPHEN (BULK)

DMF 31421978

ELI LILLY AND COInactiveACETAMINOPHEN CAPSULES

DMF 35951979

HOECHST AGInactiveACETAMINOPHEN, BULK FORM

DMF 43551981

PT RIASIMA ABADI INDUSTRI KIMIA FARMASI PERTAMAInactiveACETAMINOPHEN

DMF 46111982

SANOFI PHARMACEUTICALS INCInactiveACETAMINOPHEN

DMF 50481983

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDInactiveACETAMINOPHEN USP XX PWD & ACETAMINOPHEN W/10% STARCH

DMF 50611983

YAMAMOTO CHEMICAL INDUSTRIES CO LTDInactiveACETAMINOPHEN USP XX

DMF 55491984

MALLINCKRODT SPECIALTY CHEMICALS COInactiveACETAMINOPHEN

DMF 56831985

ILKIM ASInactiveACETAMINOPHEN USP

DMF 60271985

ADARE PHARMACEUTICALS INCInactiveACETAMINOPHEN, MICROENCAPSULATED

DMF 60821985

MIKART INCInactiveACETAMINOPHEN & CODEINE PHOSPHATE TABS. 650/60

DMF 60891985

MATERIALS PROCESSING TECHNOLOGY INCInactiveACETAMINOPHEN,73% GRANULATION

DMF 61681986

MIKART INCInactiveACETAMINOPHEN AND HYDROCODONE BITARTRATE

DMF 62071986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN USP

DMF 62451986

FARMSON PHARMACEUTICAL GUJARAT PRIVATE LTDInactiveACETAMINOPHEN

DMF 62761986

MATERIALS PROCESSING TECHNOLOGY INCInactiveACETAMINOPHEN 90%

DMF 63371986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN D.C. PVP

DMF 65721986

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN D.C. 90 PVP

DMF 65731986

BASF CORPInactiveACETAMINOPHEN

DMF 74621988

REINO CHEMICAL INDUSTRIAL CORPInactiveACETAMINOPHEN

DMF 76761988

HARTINGTON CHEMICALS DIV STAVELEY CHEMICALS LTDInactiveACETAMINOPHEN DC-PGS

DMF 77631988

DM GRAHAM LABORATORIES INCInactiveACETAMINOPHEN CONTROLLED-RELEASE BEADS 325 MG.

DMF 94761991

TRITON LABORATORIES PRIVATE LTDInactiveACETAMINOPHEN

DMF 99841992

INDUSTRIAS MONFEL SA DE CVInactiveACETAMINOPHEN

DMF 146381999

WUXI SHANHE GROUP NO 1 PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN (PARACETAMOL)

DMF 152262001

WENZHOU PHARMACEUTICAL FACTORYInactiveACETAMINOPHEN DC GRANULAR

DMF 163482003

HENGSHUI JIHENG PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN

DMF 170052003

DINESH PHARMACEUTICALS PRIVATE LTDInactiveACETAMINOPHEN USP

DMF 174792004

GRANULES INDIA LTDInactiveACETAMINOPHEN

DMF 177212004

ANQIU LUAN PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN DC 90 6

DMF 219612008

ANQIU LUAN PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN, OTC

DMF 225042009

ANHUI BBCA LIKANG PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN

DMF 252132011

FARMSON PHARMACEUTICAL GUJARAT PRIVATE LTDInactiveACETAMINOPHEN USP

DMF 274672014

ZHEJIANG KANGLE PHARMACEUTICAL CO LTDInactiveACETAMINOPHEN DC90 FINE

DMF 283022014

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Feb 10, 2020	SUPPL -35	View Letter (PDF)
Aug 13, 2015	SUPPL -34	View Letter (PDF)
Jan 17, 2014	SUPPL -32	View Letter (PDF)
Apr 8, 2010	SUPPL -28	View Letter (PDF)
Jul 1, 2008	SUPPL -25	View Letter (PDF)
Nov 8, 2007	SUPPL -24	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 650MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 325MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Approved Prior to Jan 1, 1982

#003 — 120MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Sep 12, 1983

#004 — 80MG

RLD

0 patents0 exclusivities▾

SUPPOSITORY;RECTAL | Approved: Aug 26, 1992