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

475 trials from ClinicalTrials.gov — 5 recruiting, 7 active, 351 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
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
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
A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis NCT04221477	Phase 3	Active	Hoffmann-La Roche	271	2020-08-10 → 2031-03-02
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
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 → 2027-12-31
Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia NCT03805932	Phase 1	Active	National Cancer Institute (NCI)	18	2019-10-03 → 2029-06-30
Post-Op Pain Control for Prophylactic Intramedullary Nailing.NCT03823534	Phase 3	Recruiting	St. Louis University	60	2019-02-20 → 2027-03-31
Supracondylar Post-Operative Pain Study NCT03759028	Phase 4	Recruiting	University of California, Los Angeles	90	2019-02-26 → 2027-12-20
Opioids Versus Non-Opioids Postoperative After Knee Arthroscopic Surgery NCT03858231	Phase 4	Recruiting	Sanford Health	148	2018-10-29 → 2028-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 3 NDCs

Highest NADAC/Unit

$0.9781

per ea

Lowest NADAC/Unit

$0.9122

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
51672211602FEVERALL 325 MG SUPPOSITORY	$0.9781	EA	Brand	—	2026-06-17
51672211502FEVERALL 120 MG SUPPOSITORY	$0.9255	EA	Brand	$0.2429	2026-05-20
51672211402FEVERALL 80 MG SUPPOSITORY	$0.9122	EA	Brand	—	2026-05-20

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

API Supply Chain22 active DMFs36 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

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

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

DMF 174412004

DINESH PHARMACEUTICALS PRIVATE LTDInactiveACETAMINOPHEN USP

DMF 174792004

SRI KRISHNA PHARMACEUTICALS LTDInactiveACETAMINOPHEN GRANULES DC 90%

DMF 176062004

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

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