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Tramadol Hydrochloride Patent Expiration

Tramadol Hydrochloride was first introduced by Janssen Pharmaceuticals Inc in its drug Ultram on Mar 3, 1995. Other drugs containing Tramadol Hydrochloride are Rybix Odt, Ryzolt, Qdolo, Ultram Er, Conzip. 35 different companies have introduced drugs containing Tramadol Hydrochloride.


Tramadol Hydrochloride Patents

Given below is the list of patents protecting Tramadol Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Conzip US7858118 Extended release composition containing Tramadol Apr 11, 2022

(Expired)

 Cipher Pharms Inc
Qdolo US11103452 Tramadol hydrochloride solution Sep 01, 2040 Athena
Qdolo US11752103 Tramadol hydrochloride solution Sep 01, 2040 Athena
Rybix Odt US5464632 Rapidly disintegratable multiparticular tablet Mar 22, 2013

(Expired)

 Shionogi Inc
Rybix Odt US6106861 Multiparticulate tablet disintegrating in less than 40 seconds in the mouth Dec 05, 2017

(Expired)

 Shionogi Inc
Ryzolt US5591452 Controlled release formulation May 10, 2014

(Expired)

 Purdue Pharma
Ryzolt US6254887 Controlled release tramadol May 10, 2014

(Expired)

 Purdue Pharma
Ryzolt US6607748 Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture Jun 29, 2020

(Expired)

 Purdue Pharma
Ryzolt US7988998 Sustained-release tramadol formulations with 24-hour efficacy Oct 27, 2023

(Expired)

 Purdue Pharma
Ultram US6339105 Analgesic regimen Oct 12, 2019

(Expired)

 Janssen Pharms
Ultram US6339105

(Pediatric)

 Analgesic regimen Apr 12, 2020

(Expired)

 Janssen Pharms



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tramadol Hydrochloride's patents.

Given below is the list recent legal activities going on the following patents of Tramadol Hydrochloride.

Activity Date Patent Number
Patent litigations
Email Notification
Critical
 12 Sep, 2023 US11752103
Mail Patent eGrant Notification 12 Sep, 2023 US11752103
Recordation of Patent Grant Mailed
Critical
 12 Sep, 2023 US11752103
Patent Issue Date Used in PTA Calculation
Critical
 12 Sep, 2023 US11752103
Recordation of Patent eGrant 12 Sep, 2023 US11752103
Patent eGrant Notification 12 Sep, 2023 US11752103
Email Notification
Critical
 24 Aug, 2023 US11752103
Issue Notification Mailed
Critical
 23 Aug, 2023 US11752103
Application Is Considered Ready for Issue
Critical
 10 Aug, 2023 US11752103
Dispatch to FDC 10 Aug, 2023 US11752103



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Tramadol Hydrochloride Generics

Several generic applications have been filed for Tramadol Hydrochloride. The first generic version for Tramadol Hydrochloride was by Actavis Elizabeth Llc and was approved on Jun 19, 2002. And the latest generic version is by Graviti Pharmaceuticals Private Ltd and was approved on Aug 2, 2024.

Given below is the list of companies who have filed for Tramadol Hydrochloride generic.


1. ACCORD HLTHCARE

Accord Healthcare Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Accord Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A May 16, 2013


2. ACI

Aci Healthcare Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Aci.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Nov 28, 2011


3. ACTAVIS ELIZABETH

Actavis Elizabeth Llc has filed for 4 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 19, 2002
100MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012
200MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012
300MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012


4. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jun 20, 2002


5. APOTEX

Apotex Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jul 10, 2002


6. ASTA

Asta Medica Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Asta.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jul 12, 2002


7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Mar 31, 2014
100MG tablet, extended release Discontinued ORAL N/A Oct 20, 2015
200MG tablet, extended release Discontinued ORAL N/A Oct 20, 2015
300MG tablet, extended release Discontinued ORAL N/A Oct 20, 2015


8. CSPC OUYI PHARM CO

Cspc Ouyi Pharmaceutical Co Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Cspc Ouyi Pharm Co.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Mar 29, 2013


9. ENDO OPERATIONS

Endo Operations Ltd has filed for 3 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012
100MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012
300MG tablet, extended release Discontinued ORAL N/A Jun 27, 2012


10. GRAVITI PHARMS

Graviti Pharmaceuticals Private Ltd has filed for 2 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Graviti Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 25, 2002
100MG tablet Prescription ORAL AB Aug 2, 2024


11. IPCA LABS LTD

Ipca Laboratories Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Ipca Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Nov 16, 2012


12. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Ivax Sub Teva Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jul 3, 2002


13. LUPIN LTD

Lupin Ltd has filed for 3 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
300MG tablet, extended release Prescription ORAL AB1 Aug 29, 2011
100MG

(reference standard)

tablet, extended release Prescription ORAL AB1 Aug 29, 2011
200MG tablet, extended release Prescription ORAL AB1 Aug 29, 2011


14. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Sep 25, 2015


15. MERRO PHARM USA

Merro Pharmaceutical Usa Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Merro Pharm Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jul 2, 2019


16. MYLAN

Mylan Pharmaceuticals Inc has filed for 4 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 21, 2002
200MG tablet, extended release Discontinued ORAL N/A Dec 22, 2015
100MG tablet, extended release Discontinued ORAL N/A Dec 22, 2015
300MG tablet, extended release Discontinued ORAL N/A Dec 22, 2015


17. MYLAN PHARMS INC

Mylan Pharmaceuticals Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Mylan Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Nov 21, 2002


18. NORTHSTAR HLTHCARE

Northstar Healthcare Holdings Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Northstar Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A May 26, 2010


19. PLIVA

Pliva Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Pliva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jul 1, 2002


20. RUBICON

Rubicon Research Private Ltd has filed for 4 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jun 28, 2019
100MG tablet Prescription ORAL AB Jun 28, 2019
25MG tablet Prescription ORAL N/A Nov 27, 2023
75MG tablet Prescription ORAL N/A Apr 4, 2024


21. SPECGX LLC

Specgx Llc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Specgx Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 25, 2002


22. STRIDES PHARMA

Strides Pharma Global Pte Ltd has filed for 3 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Strides Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet, extended release Discontinued ORAL N/A Nov 13, 2009
100MG tablet, extended release Discontinued ORAL N/A Nov 13, 2009
300MG tablet, extended release Discontinued ORAL N/A Sep 20, 2011


23. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 3 different strengths of generic version for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
200MG tablet, extended release Discontinued ORAL N/A Dec 30, 2011
100MG tablet, extended release Discontinued ORAL N/A Dec 30, 2011
300MG tablet, extended release Discontinued ORAL N/A Dec 30, 2011


24. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Inds Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG

(reference standard)

tablet Prescription ORAL AB Jun 19, 2002


25. SUN PHARM INDUSTRIES

Sun Pharmaceutical Industries Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Sun Pharm Industries.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 20, 2002


26. TEVA

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jun 19, 2002


27. UNICHEM

Unichem Laboratories Ltd has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Aug 9, 2019


28. WATSON LABS

Watson Laboratories has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Discontinued ORAL N/A Jun 24, 2002


29. ZYDUS PHARMS USA INC

Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Tramadol Hydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
50MG tablet Prescription ORAL AB Jan 31, 2011