Tramadol Hydrochloride Patent Expiration
Tramadol Hydrochloride was first introduced by Janssen Pharmaceuticals Inc
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.
Latest Legal Activities on Tramadol Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Tramadol Hydrochloride.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Email Notification | 12 Sep, 2023 | US11752103 |
| Mail Patent eGrant Notification | 12 Sep, 2023 | US11752103 |
| Recordation of Patent Grant Mailed | 12 Sep, 2023 | US11752103 |
| Patent Issue Date Used in PTA Calculation | 12 Sep, 2023 | US11752103 |
| Recordation of Patent eGrant | 12 Sep, 2023 | US11752103 |
| Patent eGrant Notification | 12 Sep, 2023 | US11752103 |
| Email Notification | 24 Aug, 2023 | US11752103 |
| Issue Notification Mailed | 23 Aug, 2023 | US11752103 |
| Application Is Considered Ready for Issue | 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 Rubicon Research Private Ltd and was approved on Apr 4, 2024.
Given below is the list of companies who have filed for Tramadol Hydrochloride generic.
1. GRAVITI PHARMS
Graviti Pharmaceuticals Private Ltd has filed for 1 generic 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 |
2. 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 |
3. 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 |
|---|---|---|---|---|---|
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Nov 13, 2009 |
| 200MG | tablet, extended release | Discontinued | ORAL | N/A | Nov 13, 2009 |
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Sep 20, 2011 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
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 |
| 200MG | tablet, extended release | Prescription | ORAL | AB1 | Aug 29, 2011 |
| 100MG
(reference standard) | tablet, extended release | Prescription | ORAL | AB1 | Aug 29, 2011 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 27, 2012 |
| 200MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 27, 2012 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 27, 2012 |
18. 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 |
19. 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 |
20. 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 |
21. 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 |
22. 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 |
|---|---|---|---|---|---|
| 100MG | tablet | Prescription | ORAL | N/A | Jun 28, 2019 |
| 50MG | 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 |
23. 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 |
24. 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 |
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 22, 2015 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 22, 2015 |
25. 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 |
26. 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 |
27. 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 |
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Oct 20, 2015 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Oct 20, 2015 |
| 200MG | tablet, extended release | Discontinued | ORAL | N/A | Oct 20, 2015 |
28. 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 |
|---|---|---|---|---|---|
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 30, 2011 |
| 200MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 30, 2011 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Dec 30, 2011 |
29. 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 |
| 300MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 27, 2012 |
| 100MG | tablet, extended release | Discontinued | ORAL | N/A | Jun 27, 2012 |