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 Ultram Er, Ryzolt, Rybix Odt, Qdolo, Conzip. 34 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
Qdolo US11103452 Tramadol hydrochloride solution Sep 01, 2040 Athena
Qdolo US11752103 Tramadol hydrochloride solution Sep 01, 2040 Athena
Ryzolt US7988998 Sustained-release tramadol formulations with 24-hour efficacy Oct 27, 2023

(Expired)

Purdue Pharma
Conzip US7858118 Extended release composition containing Tramadol Apr 11, 2022

(Expired)

Cipher Pharms Inc
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
Ultram US6339105

(Pediatric)

Analgesic regimen Apr 12, 2020

(Expired)

Janssen Pharms
Ultram US6339105 Analgesic regimen Oct 12, 2019

(Expired)

Janssen Pharms
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
Rybix Odt US5464632 Rapidly disintegratable multiparticular tablet Mar 22, 2013

(Expired)

Shionogi Inc



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 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


Tramadol Hydrochloride's Family Patents

Family Patents

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Tramadol Hydrochloride Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


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. 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


Manufacturing Plant Locations
New

Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.

Country City Firm Name
United States
Elizabeth Actavis Elizabeth LLC, A Company of Teva





3. 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





4. 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


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Richmond Hill Apotex Inc.
Toronto Apotex Inc.
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited





5. 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


Manufacturing Plant Locations
New

Asta's manufacturing plants are situated in 3 countries - Lithuania, Sweden, United States. Given below are the details of these plant locations as well as the firm names of Asta as present at those locations.

Country City Firm Name
Lithuania
Kovno, Na Lt-50009 Asta Baranauskaite, M.D.
Sweden
Gustavsberg AstaReal AB
United States
Burlington AstaReal, Inc.





6. 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


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





7. 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





8. 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





9. 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





10. 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





11. 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





12. 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


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





13. 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





14. 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





15. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Greensboro Mylan Pharmaceuticals Inc
Morgantown Mylan Specialty, L.P.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans Mylan Technologies, Inc.
Rockford Mylan Institutional, Inc.
San Carlos Mylan Pharmaceuticals Inc.
India
Aurangabad Mylan Laboratories Limited (FDF-2)
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Hyderabad Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





16. 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





17. 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





18. 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


Manufacturing Plant Locations
New

Pliva's manufacturing plants are situated in 3 countries - Croatia, United States, Czech Republic. Given below are the details of these plant locations as well as the firm names of Pliva as present at those locations.

Country City Firm Name
Croatia
Brdovec Pliva Hrvatska d.o.o.
Zagreb PLIVA Hrvatska d.o.o.
United States
East Hanover Pliva, Inc.
Czech Republic
Brno PLIVA-Lachema a.s.





19. 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


Manufacturing Plant Locations
New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country City Firm Name
United States
Indianapolis Rubicon Foods LLC
Geismar Rubicon, LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





20. 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


Manufacturing Plant Locations
New

Specgx Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Specgx Llc as present at those locations.

Country City Firm Name
United States
Raleigh SpecGx LLC
Greenville SpecGx LLC
Saint Louis SpecGx LLC





21. STRIDES PHARMA

Strides Pharma Global Pte 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 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
50MG

tablet Prescription ORAL AB Nov 28, 2011


Manufacturing Plant Locations
New

Strides Pharma's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Strides Pharma as present at those locations.

Country City Firm Name
United States
East Brunswick Strides Pharma Inc.
Chestnut Ridge Strides Pharma, Inc.
India
Puducherry Strides Pharma Science Limited
Bangalore Strides Pharma Science Limited





22. 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


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Mohali Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Halol Sun Pharmaceutical Industries Ltd.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd





23. 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





24. 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





25. 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


Manufacturing Plant Locations
New

Teva's manufacturing plants are situated in 6 countries - United States, India, Canada, Czech Republic, Ireland, Israel. Given below are the details of these plant locations as well as the firm names of Teva as present at those locations.

Country City Firm Name
United States
Fort Dodge TEVA Animal Health Inc
Horsham Teva Branded Pharmaceutical Products R&D
Malvern Teva Branded Pharmaceutical Products R&D, Inc.
Miami Teva Branded Pharmaceutical Products R & D, Inc.
India
Gajraula, Amroha Teva API India Private Ltd.
Bhind Teva API India Ltd- Malanpur
Canada
Stouffville Teva Canada Limited
Markham Teva Canada Limited
Scarborough Teva Canada Limited
Czech Republic
Opava Teva Czech Industries s.r.o.
Ireland
Dundalk Teva Laboratories Ireland Ltd
Israel
Kiryat-Shmona TEVA Medical Ltd.





26. 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


Manufacturing Plant Locations
New

Unichem's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Unichem as present at those locations.

Country City Firm Name
India
Ghaziabad Unichem Laboratories Ltd.
Mumbai Unichem Laboratories Limited
Kolhapur Unichem Laboratories Limited
District Raigad Unichem Laboratories Ltd
Pilerne Bardez Unichem Laboratories Limited
Pithampur Unichem Laboratories Limited
United States
East Brunswick Unichem Pharmaceuticals USA Inc.
Hasbrouck Heights Unichem Pharmaceuticals Usa Inc





27. 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





28. 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