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Last Updated: March 28, 2024

TRAMADOL HYDROCHLORIDE Drug Patent Profile


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

Tramadol Hydrochloride is a drug marketed by Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Accord Hlthcare, ACI, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Nostrum Labs Inc, and Rising. and is included in forty-four NDAs.

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

Summary for TRAMADOL HYDROCHLORIDE
Drug patent expirations by year for TRAMADOL HYDROCHLORIDE
Recent Clinical Trials for TRAMADOL HYDROCHLORIDE

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

SponsorPhase
University Hospital "Sestre Milosrdnice"N/A
Novartis PharmaceuticalsPhase 3
University of AlgiersPhase 4

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
Anatomical Therapeutic Chemical (ATC) Classes for TRAMADOL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
RYZOLT Extended-release Tablets tramadol hydrochloride 100 mg, 200 mg and 300 mg 021745 1 2009-06-18
ULTRAM ER Extended-release Tablets tramadol hydrochloride 300 mg 021692 1 2007-09-25
ULTRAM ER Extended-release Tablets tramadol hydrochloride 200 mg 021692 1 2007-03-28
ULTRAM ER Extended-release Tablets tramadol hydrochloride 100 mg 021692 1 2007-01-08

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
Pliva TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075982-001 Jul 1, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cspc Ouyi Pharm Co TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 091498-001 Mar 29, 2013 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Unichem TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 211825-001 Aug 9, 2019 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rising TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077858-001 Sep 26, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075983-001 Jun 25, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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