Viewing data from:

ULTRACET

NDA

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE | N021123 | JANSSEN PHARMACEUTICALS INC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-5984 · 7 docket documents Senores Pharmaceuticals, Inc. filed a suitability petition requesting that the FDA determine whether their proposed drug product is suitable for abbreviated new drug application (ANDA) submission, seeking a favorable eligibility determination that would allow them to proceed with developing and subm	Suitability	2026-05-27	Open	Senores Pharmaceuticals, Inc
Lachman Consultant Sevices, Inc. - Citizen Petition FDA-2013-P-0675 · 3 docket documents Lachman Consultant Services, Inc. filed this petition on June 4, 2013, pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Tramadol Hydrochloride 37.5 mg and Acetaminophen 300 mg Tablets suitable for submission as an abbreviated new drug appli	Other	2013-06-18	WithdrawnUnverified summary	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

27 trials from ClinicalTrials.gov — 1 recruiting, 22 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Nephrostomy Tract Infiltration for Pain Control After PCNL NCT07721571	N/A	Recruiting	Hitit University	60	2026-07-17 → 2027-06-11
Phase 3 Study of Tramadol Hydrochloride/Acetaminophen SR Tab. & Tramadol Hydrochloride/Acetaminophen Tab. in Acute Toothache Patients After Teeth Extraction Surgery NCT01920386	Phase 3	Completed	Daewon Pharmaceutical Co., Ltd.	240	2013-06
An Open Label Study to Evaluate Safety, Tolerability and Clinical Utility of ULTRACET® (37.5mg Tramadol Hydrochloride/325mg Acetaminophen) for the Treatment of Breakthrough Pain in Cancer Patients NCT00576173	Phase 4	Completed	Johnson & Johnson Taiwan Ltd	60	2005-12 → 2007-02
A Study of the Efficacy and Safety of Tramadol HCl/Acetaminophen, Hydrocodone Bitartrate/Acetaminophen and Placebo in Patients With Pain From an Ankle Sprain With a Partial Torn Ligament NCT00236535	Phase 3	Completed	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	603	2003-12 → 2004-10
A Long-term Efficacy and Safety Study of Tramadol Hydrochloride Plus Acetaminophen (JNS013) in Japanese Participants With Chronic Pain NCT00736957	Phase 3	Completed	Janssen Pharmaceutical K.K.	219	2008-05 → 2009-11
Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)NCT01983111	Phase 4	Completed	Mundipharma Korea Ltd	136	2013-10 → 2014-11
An Efficacy and Safety Study of Extended Release (ER) Tramadol Hydrochloride (HCl)/Acetaminophen in Participants With Chronic Low-Back Pain NCT01112267	Phase 3	Completed	Janssen Korea, Ltd., Korea	248	2009-05 → 2009-10
Epidural Analgesia for Pancreatitis (Epipan Study)NCT02126332	Phase 3	Completed	University Hospital, Clermont-Ferrand	148	2014-06-06 → 2019-02-26
A Study of the Tolerability of Titrated Dose Tramadol/Acetaminophen Combination Tablet in Korean Patients With Osteoarthritis NCT01063842	Phase 4	Completed	Janssen Korea, Ltd., Korea	250	2005-08 → 2006-05
Effect of Combined Use of Naloxone and Tramacet on Postop Analgesia in Elderly Patients Having Joint Replacement Surgery NCT00679614	Phase 3	Completed	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's	45	2007-12-17 → 2011-05-31

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

Approval Letters

15 letters from Drugs@FDA

Date	Submission	Document
Feb 14, 2023	SUPPL -15	View Letter (PDF)
Sep 14, 2021	SUPPL -21	View Letter (PDF)
Mar 5, 2021	SUPPL -20	View Letter (PDF)
Oct 8, 2019	SUPPL -19	View Letter (PDF)
Sep 28, 2018	SUPPL -17	View Letter (PDF)
Sep 28, 2018	SUPPL -16	View Letter (PDF)
Aug 30, 2017	SUPPL -14	View Letter (PDF)
Dec 20, 2016	SUPPL -13	View Letter (PDF)
Dec 20, 2016	SUPPL -10	View Letter (PDF)
Dec 20, 2016	SUPPL -12	View Letter (PDF)
Oct 21, 2013	SUPPL -8	View Letter (PDF)
Jun 28, 2011	SUPPL -5	View Letter (PDF)
Nov 10, 2009	SUPPL -3	View Letter (PDF)
Apr 20, 2004	SUPPL -1	View Letter (PDF)
Aug 15, 2001	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 15, 2001

No patent or exclusivity listings for this strength.