Baclofen Patent Expiration
Baclofen was first introduced by Novartis Pharmaceuticals Corp
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 |
|---|---|---|---|---|
| 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 |
| Lyvispah | US10792262 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | Jul 29, 2039 | Amneal |
| Lyvispah | US11491125 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations | Sep 29, 2041 | Amneal |
| Lyvispah | US11654124 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | Jul 29, 2039 | Amneal |
| Lyvispah | US11850225 | Baclofen formulations and methods of minimizing patient exposure to metabolite variations | Sep 29, 2041 | Amneal |
| Lyvispah | US11931328 | Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives | Jul 29, 2039 | Amneal |
| Ozobax | US10610502 | Oral baclofen solutions | Aug 30, 2039 | Metacel Pharms Llc |
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Baclofen Generics
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 Zydus Lifesciences Global Fze and was approved on Feb 13, 2024.
Given below is the list of companies who have filed for Baclofen generic.
1. GRAVITI PHARMS
Graviti Pharmaceuticals Private 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 Graviti Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 20MG | tablet | Prescription | ORAL | AB | Jan 10, 2024 |
| 10MG | tablet | Prescription | ORAL | AB | Jan 10, 2024 |
2. 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 |
3. 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 |
4. MYLAN LABS LTD
Mylan 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 Mylan Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 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 |
5. 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 |
|---|---|---|---|---|---|
| 0.5MG/ML | injectable | Prescription | INTRATHECAL | AP | May 3, 2016 |
| 2MG/ML | injectable | Prescription | INTRATHECAL | AP | May 3, 2016 |
| 0.05MG/ML | injectable | Prescription | INTRATHECAL | AP | May 3, 2016 |
6. 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 |
|---|---|---|---|---|---|
| 5MG | tablet | Prescription | ORAL | AB | Nov 8, 2023 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 8, 2023 |
| 20MG | tablet | Prescription | ORAL | AB | Nov 8, 2023 |
7. 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 |
8. 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 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
| 0.5MG/ML | injectable | Prescription | INTRATHECAL | AP | Sep 11, 2019 |
| 2MG/ML | injectable | Prescription | INTRATHECAL | AP | Sep 11, 2019 |
| 0.05MG/ML | injectable | Prescription | INTRATHECAL | AP | Jan 15, 2021 |
16. 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 |
17. 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 |
18. INNOGENIX
Innogenix 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 Innogenix.
| 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 |
19. 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 |
20. 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 |
21. EYWA PHARMA
Eywa Pharma Pte 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 Eywa Pharma.
| 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 |
22. RUBICON
Rubicon Research Private Ltd has filed for 7 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 |
|---|---|---|---|---|---|
| 5MG
(reference standard) | tablet | Prescription | ORAL | AB | Nov 28, 2017 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 28, 2017 |
| 20MG | tablet | Prescription | ORAL | AB | Nov 28, 2017 |
| 1MG/ML | injectable | Prescription | INTRATHECAL | AP | Feb 22, 2023 |
| 0.5MG/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 |
23. 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 |
24. MYLAN
Mylan 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 Mylan.
| 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 |
25. APPCO
Appco Pharma 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 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 |
26. 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 |
| 5MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
| 20MG | tablet | Prescription | ORAL | AB | Mar 5, 2021 |
27. 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 |
28. 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 |
29. 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 |
30. 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 |
31. 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 |
32. ACIC PHARMS
Acic 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 Acic Pharms.
| 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 |
33. 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 |
|---|---|---|---|---|---|
| 20MG | tablet | Prescription | ORAL | AB | Jan 25, 2022 |
| 5MG | tablet | Prescription | ORAL | AB | Jan 25, 2022 |
| 10MG | tablet | Prescription | ORAL | AB | Jan 25, 2022 |
34. 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 |
|---|---|---|---|---|---|
| 20MG | tablet | Prescription | ORAL | AB | Nov 23, 2018 |
| 10MG | tablet | Prescription | ORAL | AB | Nov 23, 2018 |
| 5MG | tablet | Prescription | ORAL | AB | Apr 17, 2020 |
| 15MG | tablet | Prescription | ORAL | AB | Feb 13, 2024 |