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Last Updated: August 14, 2020

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Tramadol hydrochloride - Generic Drug Details

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What are the generic drug sources for tramadol hydrochloride and what is the scope of freedom to operate?

Tramadol hydrochloride is the generic ingredient in six branded drugs marketed by Cipher Pharms Inc, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Par Pharm Inc, Sun Pharm, Valeant Pharms, Shionogi Inc, Accord Hlthcare, Aci Healthcare Ltd, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Fosun Pharma, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Polygen Pharms, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem Labs Ltd, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-eight NDAs. There are four patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has ninety-three patent family members in twenty-nine countries.

There are thirty-six drug master file entries for tramadol hydrochloride. Forty-three suppliers are listed for this compound.

Recent Clinical Trials for tramadol hydrochloride

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

SponsorPhase
Pain Management Institute Bethesda-Washington-MarylandN/A
Scilex Pharmaceuticals, Inc.N/A
Washington D.C. Veterans Affairs Medical CenterN/A

See all tramadol hydrochloride clinical trials

Pharmacology for tramadol hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for tramadol hydrochloride
Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
RYZOLT TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021745 2009-06-18
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-09-25
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-03-28
ULTRAM ER TABLET, EXTENDED RELEASE;ORAL tramadol hydrochloride 021692 2007-01-08
ULTRAM TABLET;ORAL tramadol hydrochloride 020281

US Patents and Regulatory Information for tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Rubicon TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 208708-001 Jun 28, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 091607-003 Dec 30, 2011 AB2 RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200503-003 Aug 29, 2011 AB1 RX No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 078783-002 Nov 13, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 076003-001 Jun 20, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem Labs Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 211825-001 Aug 9, 2019 AB RX No No   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 tramadol hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shionogi Inc RYBIX ODT tramadol hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021693-001 May 5, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-003 Sep 8, 2005   Start Trial   Start Trial
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005   Start Trial   Start Trial
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995   Start Trial   Start Trial
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-003 Dec 30, 2008   Start Trial   Start Trial
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-001 Dec 30, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tramadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SPC/GB04/012 United Kingdom   Start Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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