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Baclofen Patent Expiration

Baclofen was first introduced by Novartis Pharmaceuticals Corp in its drug Lioresal on Approved Prior to Jan 1, 1982. Other drugs containing Baclofen are Ozobax Ds, Fleqsuvy, Ozobax, Gablofen, Kemstro, Lyvispah. 38 different companies have introduced drugs containing Baclofen.


Baclofen Patents

Given below is the list of patents protecting Baclofen, 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
Lyvispah US11491125 Baclofen formulations and methods of minimizing patient exposure to metabolite variations Sep 29, 2041 Amneal
Lyvispah US11850225 Baclofen formulations and methods of minimizing patient exposure to metabolite variations Sep 29, 2041 Amneal
Ozobax US10610502 Oral baclofen solutions Aug 30, 2039 Metacel Pharms Llc
Lyvispah US10792262 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Amneal
Lyvispah US11654124 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Amneal
Lyvispah US11931328 Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives Jul 29, 2039 Amneal
Fleqsuvy US11324696 Suspensions and diluents for metronidazole and baclofen Sep 29, 2037 Azurity
Fleqsuvy US11446246 Suspensions and diluents for metronidazole and baclofen Sep 08, 2037 Azurity
Kemstro US6024981 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

 Ucb Inc
Kemstro US6221392 Rapidly dissolving robust dosage form Apr 09, 2018

(Expired)

 Ucb Inc



Baclofen's Family Patents

Family Patents

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Baclofen Generic API Manufacturers

Several generic applications have been filed for Baclofen. The first generic version for Baclofen was by Usl Pharma Inc and was approved on May 6, 1988. And the latest generic version is by Appco Pharma Llc and was approved on Jan 31, 2025.

Given below is the list of companies who have filed for Baclofen generic, along with the locations of their manufacturing plants worldwide.


1. AMNEAL

Amneal Pharmaceuticals Llc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05MG/ML

injectable Prescription INTRATHECAL AP May 3, 2016
2MG/ML

injectable Prescription INTRATHECAL AP May 3, 2016
0.5MG/ML

injectable Prescription INTRATHECAL AP May 3, 2016


Manufacturing Plant Locations
New

Amneal'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 Amneal as present at those locations.

Country City Firm Name
United States
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Glasgow Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Piscataway Amneal Pharmaceuticals, LLC
East Hanover Amneal Pharmaceuticals LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.





2. ANDAS 5 HOLDING

Andas 5 Holding Llc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Andas 5 Holding.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 9, 2020
20MG

tablet Prescription ORAL AB Oct 9, 2020
5MG

tablet Prescription ORAL AB Apr 30, 2021





3. ANI PHARMS

Ani Pharmaceuticals Inc has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Ani Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
25MG/5ML

suspension Prescription ORAL AB Jun 8, 2023





4. APPCO

Appco Pharma Llc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Appco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Feb 18, 2010
10MG

tablet Discontinued ORAL N/A Feb 18, 2010
5MG

tablet Prescription ORAL AB Jan 31, 2025


Manufacturing Plant Locations
New

Appco'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 Appco as present at those locations.

Country City Firm Name
United States
Somerset Appco Pharma, LLC
Piscataway Appco Pharma LLC





5. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Baclofen. 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
20MG

tablet Prescription ORAL AB Jul 13, 2021
10MG

tablet Prescription ORAL AB Jul 13, 2021


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





6. BEXIMCO PHARMS USA

Beximco Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Beximco Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Jul 16, 2021
20MG

tablet Prescription ORAL AB Jul 16, 2021
5MG

tablet Prescription ORAL AB Sep 19, 2023





7. CARACO

Caraco Pharmaceutical Laboratories Ltd has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Caraco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Aug 14, 2006


Manufacturing Plant Locations
New

Caraco'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 Caraco as present at those locations.

Country City Firm Name
United States
Farmington Hills Caraco Pharmaceutical Laboratories, LTD.
Tampa Caracolillo Coffee Mills, Inc.





8. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Baclofen. 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
20MG

tablet Prescription ORAL AB Aug 30, 2005
10MG

tablet Prescription ORAL AB Aug 30, 2005





9. GRAVITI PHARMS

Graviti Pharmaceuticals Private Ltd has filed for 3 different strengths of generic version for Baclofen. 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
10MG

tablet Prescription ORAL AB Jan 10, 2024
20MG

tablet Prescription ORAL AB Jan 10, 2024
5MG

tablet Prescription ORAL AB Oct 24, 2024





10. HERITAGE

Heritage Pharmaceuticals Inc Dba Avet Pharmaceuticals Inc has filed for 2 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Heritage.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG/ML

injectable Discontinued INTRATHECAL N/A Aug 10, 2023
2MG/ML

injectable Discontinued INTRATHECAL N/A Aug 10, 2023


Manufacturing Plant Locations
New

Heritage'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 Heritage as present at those locations.

Country City Firm Name
United States
Alger Heritage Cooperative
Beloit Heritage Cooperative
Morgantown Heritage Animal Hospital
De Graff Heritage Cooperative Inc
West Mansfield Heritage Cooperative Inc.
New Philadelphia Heritage Cooperative
Springfield Heritage Cooperative, Inc
Ada Heritage Cooperative Inc
London Heritage Cooperative, Inc
Fort Scott Heritage Acres Farm
Van Nuys Heritage Candy Company, Inc.
Sacramento Heritage Baking Company Inc.
Mc Cutchenville Heritage Cooperative, Inc
West Liberty Heritage Cooperative, Inc
Upper Sandusky Heritage Cooperative
Middlebury Heritage Acres
Vanlue Heritage Cooperative
Waterford Heritage Cooperative
Kenton Heritage Cooperative
Chino Heritage #2
Minneapolis Heritage Deli Provisions, LLC
Caldwell Heritage Country Store-Heritage Cooperative
Cairo Heritage Cooperative
London Heritage Cooperative Inc.
Lisbon Heritage Cooperative, Inc.
South Burlington Heritage Aviation
Woodsfield Heritage Cooperative
Dola Heritage Cooperative Inc
Richwood Heritage Cooperative, Inc
Urbana Heritage Cooperative Inc
Canfield Heritage Cooperative
Fletcher Heritage Cooperative Inc
Plain City Heritage Cooperative Inc.





11. HIBROW HLTHCARE

Hibrow Healthcare Private Ltd has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Hibrow Hlthcare.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL BX Feb 1, 2019
20MG

tablet Prescription ORAL BX Feb 1, 2019
5MG

tablet Prescription ORAL BX Nov 30, 2021





12. IMPAX

Impax Laboratories Llc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Impax.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Oct 26, 2007
10MG

tablet Discontinued ORAL N/A Oct 26, 2007
5MG

tablet Discontinued ORAL N/A Jul 7, 2021


Manufacturing Plant Locations
New

Impax'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 Impax as present at those locations.

Country City Firm Name
United States
Hayward Impax Laboratories, LLC.





13. IMPAX LABS

Impax Laboratories Inc has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Impax Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 26, 2007





14. IVAX SUB TEVA PHARMS

Ivax Pharmaceuticals Inc Sub Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Baclofen. 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
10MG

tablet Prescription ORAL AB Jul 21, 1988
20MG

(reference standard)

tablet Prescription ORAL AB Jul 21, 1988





15. LANNETT

Lannett Holdings Inc has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Lannett.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Jul 6, 2007


Manufacturing Plant Locations
New

Lannett'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 Lannett as present at those locations.

Country City Firm Name
United States
Seymour Lannett Company Inc.
Philadelphia Lannett Company, Inc.





16. LANNETT CO INC

Lannett Co Inc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Dec 20, 2005
10MG

tablet Prescription ORAL AB Jul 6, 2007
5MG

tablet Prescription ORAL AB Sep 22, 2021





17. MAIA PHARMS INC

Maia Pharmaceuticals Inc has filed for 4 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Maia Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG/ML

injectable Prescription INTRATHECAL AP Jul 30, 2019
2MG/ML

injectable Prescription INTRATHECAL AP Sep 11, 2019
0.5MG/ML

injectable Prescription INTRATHECAL AP Sep 11, 2019
0.05MG/ML

injectable Prescription INTRATHECAL AP Jan 15, 2021





18. MANKIND PHARMA

Mankind Pharma Ltd has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Mankind Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Jan 25, 2022
20MG

tablet Prescription ORAL AB Jan 25, 2022
10MG

tablet Prescription ORAL AB Jan 25, 2022


Manufacturing Plant Locations
New

Mankind Pharma'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 Mankind Pharma as present at those locations.

Country City Firm Name
India
Imt Manesar Mankind Pharma Limited
Paonta Sahib Mankind Pharma Limited





19. MICRO LABS

Micro Labs Ltd has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Micro Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Nov 8, 2023
5MG

tablet Prescription ORAL AB Nov 8, 2023
20MG

tablet Prescription ORAL AB Nov 8, 2023


Manufacturing Plant Locations
New

Micro Labs'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 Micro Labs as present at those locations.

Country City Firm Name
India
Verna Micro Labs Limited
Bengaluru Micro Labs Limited, Central Analytical Laboratory
Bengaluru Micro Labs Limited
Bangalore Micro Labs Limited





20. NORTHSTAR HLTHCARE

Northstar Healthcare Holdings Ltd has filed for 2 different strengths of generic version for Baclofen. 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
10MG

tablet Prescription ORAL AB Sep 18, 2009
20MG

tablet Prescription ORAL AB Sep 18, 2009





21. NORVIUM BIOSCIENCE

Norvium Bioscience Llc has filed for 5 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Jul 29, 2005
10MG

tablet Discontinued ORAL N/A Jul 29, 2005
1MG/ML

injectable Prescription INTRATHECAL AP Mar 6, 2018
2MG/ML

injectable Prescription INTRATHECAL AP Mar 21, 2018
0.5MG/ML

injectable Prescription INTRATHECAL AP Mar 21, 2018





22. OXFORD PHARMS

Oxford Pharmaceuticals Llc has filed for 2 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Oxford Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 31, 2007
20MG

tablet Prescription ORAL AB Oct 31, 2007





23. PROSAM LABS

Prosam Labs Llc has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Prosam Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Oct 31, 2007





24. RISING

Rising Pharma Holdings Inc has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Mar 5, 2021
20MG

tablet Prescription ORAL AB Mar 5, 2021
5MG

tablet Prescription ORAL AB Mar 5, 2021


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Mount Morris Rising Creek Bakery LLC
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Phoenix Rising Sun Farms Inc
Saddle Brook Rising Pharmaceuticals, Inc.
East Brunswick Rising Pharma Holding, Inc.
Fort Bragg Rising Tide Sea Vegetables
Rising Sun Rising Sun Veterinary Clinic
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





25. RUBICON

Rubicon Research Private Ltd has filed for 8 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Rubicon.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Nov 28, 2017
5MG

(reference standard)

tablet Prescription ORAL AB Nov 28, 2017
10MG

tablet Prescription ORAL AB Nov 28, 2017
0.5MG/ML

injectable Prescription INTRATHECAL AP Feb 22, 2023
1MG/ML

injectable Prescription INTRATHECAL AP Feb 22, 2023
2MG/ML

injectable Prescription INTRATHECAL AP Feb 22, 2023
15MG

tablet Prescription ORAL AB Feb 5, 2024
5MG/5ML

solution Prescription ORAL N/A Dec 6, 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
Geismar Rubicon, LLC
Indianapolis Rubicon Foods LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





26. SUN PHARM INDS INC

Sun Pharmaceutical Industries Inc has filed for 2 different strengths of generic version for Baclofen. 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
20MG

tablet Discontinued ORAL N/A Aug 14, 2006
10MG

tablet Discontinued ORAL N/A Aug 14, 2006





27. TEVA

Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A Feb 27, 1992
10MG

tablet Discontinued ORAL N/A Feb 27, 1992


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





28. UNICHEM

Unichem Laboratories Ltd has filed for 3 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Unichem.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Prescription ORAL AB Jul 9, 2020
10MG

tablet Prescription ORAL AB Jul 9, 2020
5MG

tablet Prescription ORAL AB Mar 9, 2023


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





29. UPSHER SMITH LABS

Upsher Smith Laboratories Llc has filed for 2 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Upsher Smith Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Aug 19, 1996
20MG

tablet Prescription ORAL AB Aug 19, 1996





30. USL PHARMA

Usl Pharma Inc has filed for 2 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Usl Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG

tablet Discontinued ORAL N/A May 6, 1988
10MG

tablet Discontinued ORAL N/A May 6, 1988





31. VINTAGE PHARMS

Vintage Pharmaceuticals Inc has filed for 1 generic for Baclofen. Given below are the details of the strengths of this generic introduced by Vintage Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Aug 30, 2005





32. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Baclofen. 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
20MG

tablet Discontinued ORAL N/A Aug 20, 1996
10MG

tablet Discontinued ORAL N/A Aug 20, 1996





33. ZYDUS LIFESCIENCES

Zydus Lifesciences Global Fze has filed for 4 different strengths of generic version for Baclofen. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Nov 23, 2018
20MG

tablet Prescription ORAL AB Nov 23, 2018
5MG

tablet Prescription ORAL AB Apr 17, 2020
15MG

tablet Prescription ORAL AB Feb 13, 2024


Manufacturing Plant Locations
New

Zydus Lifesciences'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 Zydus Lifesciences as present at those locations.

Country City Firm Name
India
District Solan Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Matoda Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited