Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Baxter
Boehringer Ingelheim
Express Scripts
Colorcon

Last Updated: January 30, 2023

Tramadol hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 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 three patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has sixty-two patent family members in twenty-six countries.

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

Summary for tramadol hydrochloride
International Patents:62
US Patents:3
Tradenames:7
Applicants:35
NDAs:39
Drug Master File Entries: 34
Finished Product Suppliers / Packagers: 41
Raw Ingredient (Bulk) Api Vendors: 89
Clinical Trials: 436
Patent Applications: 4,249
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
Sana BahadurPhase 2
Beni-Suef UniversityPhase 2
Hospital Universitario de BurgosPhase 4

See all tramadol hydrochloride clinical trials

Pharmacology for tramadol hydrochloride
Drug Class Opioid 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
Lupin Ltd TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200503-001 Aug 29, 2011 AB1 RX No Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Strides Pharma TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 078783-003 Sep 20, 2011 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anchen Pharms TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200491-002 Jun 27, 2012 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Sun Pharm TRAMADOL HYDROCHLORIDE tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 201384-003 Dec 7, 2011 AB1 RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Valeant Pharms ULTRAM ER tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021692-001 Sep 8, 2005 See Plans and Pricing See Plans and Pricing
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-001 Dec 30, 2008 See Plans and Pricing See Plans and Pricing
Janssen Pharms ULTRAM tramadol hydrochloride TABLET;ORAL 020281-002 Mar 3, 1995 See Plans and Pricing See Plans and Pricing
Cipher Pharms Inc CONZIP tramadol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022370-001 May 7, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for tramadol hydrochloride

Country Patent Number Title Estimated Expiration
Germany 60320039 See Plans and Pricing
Australia 2003275855 SUSTAINED-RELEASE TRAMADOL FORMULATIONS WITH 24-HOUR EFFICACY See Plans and Pricing
Ecuador SP055749 FORMULACION DE TRAMADOL DE LIBERACION SOSTENIDA CON EFICACIA DE 24 HORAS See Plans and Pricing
Japan 4897930 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for tramadol hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0566709 SPC/GB04/012 United Kingdom See Plans and Pricing PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
0566709 C300152 Netherlands See Plans and Pricing PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
Dow
Mallinckrodt
McKinsey
Moodys

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.