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Last Updated: March 19, 2024

TRAMADOL HYDROCHLORIDE - Generic Drug Details


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What are the generic drug sources for tramadol hydrochloride and what is the scope of patent protection?

Tramadol hydrochloride is the generic ingredient in seven branded drugs marketed by Cipher Pharms Inc, Athena, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Aurobindo Pharma Ltd, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Valeant Pharms, Shionogi Inc, 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, and Janssen Pharms, and is included in thirty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has one patent family member in one country.

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

Summary for TRAMADOL HYDROCHLORIDE
International Patents:1
US Patents:2
Tradenames:7
Applicants:35
NDAs:39
Drug Master File Entries: 34
Finished Product Suppliers / Packagers: 45
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 453
Patent Applications: 3,850
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in TRAMADOL HYDROCHLORIDE?TRAMADOL HYDROCHLORIDE excipients list
DailyMed Link:TRAMADOL HYDROCHLORIDE at DailyMed
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
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
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
Actavis Elizabeth TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET;ORAL 075960-001 Jun 19, 2002 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 091607-001 Dec 30, 2011 RX No Yes ⤷  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

Expired US Patents for TRAMADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 ⤷  Try a Trial ⤷  Try a Trial
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995 ⤷  Try a Trial ⤷  Try a Trial
Cipher Pharms Inc CONZIP tramadol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370-001 May 7, 2010 ⤷  Try a Trial ⤷  Try a 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 ⤷  Try a 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 ⤷  Try a 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.