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Last Updated: October 26, 2020

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ULTRACET Drug Profile

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When do Ultracet patents expire, and what generic alternatives are available?

Ultracet is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in ULTRACET is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

Drug patent expirations by year for ULTRACET
Drug Prices for ULTRACET

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Recent Clinical Trials for ULTRACET

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PfizerPhase 4
Gia Dinh People HospitalN/A
The Catholic University of KoreaN/A

See all ULTRACET clinical trials

Pharmacology for ULTRACET
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ULTRACET
Tradename Dosage Ingredient NDA Submissiondate
ULTRACET TABLET;ORAL acetaminophen; tramadol hydrochloride 021123

US Patents and Regulatory Information for ULTRACET

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ULTRACET

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ULTRACET

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0566709 300152 Netherlands   Start Trial 300152, 20120903, EXPIRES: 20170404
0566709 SPC023/2008 Ireland   Start Trial SPC023/2008: 20090921, EXPIRES: 20170404
0566709 SPC/GB04/012 United Kingdom   Start Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709 C300152 Netherlands   Start Trial PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709 91079 Luxembourg   Start Trial 91079, EXPIRES: 20170903
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
AstraZeneca
Colorcon
McKinsey
Express Scripts

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