Pramipexole Dihydrochloride Patent Expiration
Pramipexole Dihydrochloride is Used for treating moderate to severe primary Restless Legs Syndrome (RLS). It was first introduced by Boehringer Ingelheim
Pramipexole Dihydrochloride Patents
Given below is the list of patents protecting Pramipexole Dihydrochloride, 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 |
|---|---|---|---|---|
| Mirapex | US6001861 | Use of pramipexole in the treatment of restless legs syndrome |
Jan 16, 2018
(Expired) | Boehringer Ingelheim |
| Mirapex | US6194445 | Use of pramipexole in the treatment of restless legs syndrome |
Jan 16, 2018
(Expired) | Boehringer Ingelheim |
| Mirapex Er | US7695734 | Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof | Apr 26, 2028 | Boehringer Ingelheim |
| Mirapex Er | US8679533 | Pramipexole once-daily dosage form | Sep 08, 2029 | Boehringer Ingelheim |
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Pramipexole Dihydrochloride Generics
Several generic applications have been filed for Pramipexole Dihydrochloride. The first generic version for Pramipexole Dihydrochloride was by Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc and was approved on Feb 19, 2008. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Nov 23, 2022.
Given below is the list of companies who have filed for Pramipexole Dihydrochloride generic.
1. NOSTRUM LABS INC
Nostrum Laboratories Inc has filed for 5 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Nostrum Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.125MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
2. STRIDES PHARMA
Strides Pharma Global Pte Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 1.5MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
| 0.25MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
| 0.5MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
| 0.75MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
| 1MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
| 0.125MG | tablet | Prescription | ORAL | AB | Jun 3, 2014 |
3. UNICHEM
Unichem Laboratories Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Unichem.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
| 0.75MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
| 1MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
| 1.5MG | tablet | Discontinued | ORAL | N/A | Dec 19, 2018 |
4. ZYDUS PHARMS USA INC
Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 1.5MG | tablet | Prescription | ORAL | AB | Jul 6, 2010 |
| 1MG | tablet | Prescription | ORAL | AB | Jul 6, 2010 |
| 0.5MG | tablet | Prescription | ORAL | AB | Jul 6, 2010 |
| 0.25MG | tablet | Prescription | ORAL | AB | Jul 6, 2010 |
| 0.125MG | tablet | Prescription | ORAL | AB | Jul 6, 2010 |
| 0.75MG | tablet | Prescription | ORAL | AB | Nov 23, 2022 |
5. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 11 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.125MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 3.75MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 2.25MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Jan 2, 2019 |
6. TORRENT PHARMS
Torrent Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Torrent Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.125MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.25MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.75MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 1.5MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
7. SUN PHARM INDS INC
Sun Pharmaceutical Industries Inc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 1.5MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
| 0.75MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
| 1MG | tablet | Discontinued | ORAL | N/A | Mar 27, 2013 |
8. HERITAGE PHARMA AVET
Heritage Pharma Labs Inc Dba Avet Pharmaceuticals Labs Inc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Heritage Pharma Avet.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
| 1.5MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
| 0.75MG | tablet | Discontinued | ORAL | N/A | Nov 30, 2010 |
9. ZENNOVA
Zennova Pharmaceuticals Chengdu Co Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Zennova.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.5MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
| 0.25MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
| 0.125MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
| 1.5MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
| 1MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
| 0.75MG | tablet | Prescription | ORAL | AB | Apr 30, 2012 |
10. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 7 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 3.75MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 2.25MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Dec 12, 2017 |
11. ACTAVIS ELIZABETH
Actavis Elizabeth Llc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 7 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Apr 21, 2016 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Apr 21, 2016 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Apr 21, 2016 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Apr 21, 2016 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Apr 21, 2016 |
| 2.25MG | tablet, extended release | Prescription | ORAL | AB | Oct 14, 2016 |
| 3.75MG | tablet, extended release | Prescription | ORAL | AB | Jan 3, 2017 |
12. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
13. SANDOZ
Sandoz Inc has filed for 9 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1MG | tablet | Discontinued | ORAL | N/A | Jul 6, 2010 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Dec 4, 2014 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Jul 6, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Jul 6, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Jul 6, 2010 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Dec 4, 2014 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Dec 4, 2014 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Dec 4, 2014 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Dec 4, 2014 |
14. SCIEGEN PHARMS INC
Sciegen Pharmaceuticals Inc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Sciegen Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.25MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
| 0.125MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
| 1.5MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
| 0.75MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 28, 2014 |
15. MACLEODS PHARMS LTD
Macleods Pharmaceuticals Ltd has filed for 11 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 1MG | tablet | Discontinued | ORAL | N/A | Sep 20, 2012 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Sep 20, 2012 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Sep 20, 2012 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Sep 20, 2012 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 2.25MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Jun 24, 2016 |
| 3.75MG | tablet, extended release | Prescription | ORAL | AB | Jan 23, 2017 |
16. GLENMARK PHARMS LTD
Glenmark Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.125MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.25MG
(reference standard) | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 1.5MG | tablet | Prescription | ORAL | AB | Oct 8, 2010 |
| 0.75MG | tablet | Prescription | ORAL | AB | Sep 11, 2015 |
17. MYLAN
Mylan Pharmaceuticals Inc has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.75MG | tablet | Discontinued | ORAL | N/A | Apr 9, 2010 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.125MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
| 1.5MG | tablet | Discontinued | ORAL | N/A | Oct 8, 2010 |
18. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 5 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Aug 7, 2015 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Aug 7, 2015 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Aug 7, 2015 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Aug 7, 2015 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Aug 7, 2015 |
19. RISING
Rising Pharma Holding Inc has filed for 5 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.5MG | tablet | Prescription | ORAL | AB | Oct 3, 2018 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 3, 2018 |
| 0.75MG | tablet | Prescription | ORAL | AB | Oct 3, 2018 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 3, 2018 |
| 0.25MG | tablet | Prescription | ORAL | AB | Oct 3, 2018 |
20. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 6 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 0.125MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
| 0.25MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
| 0.5MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
| 0.75MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
| 1MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
| 1.5MG | tablet | Prescription | ORAL | AB | Oct 26, 2012 |
21. ENDO OPERATIONS
Endo Operations Ltd has filed for 7 different strengths of generic version for Pramipexole Dihydrochloride. 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 |
|---|---|---|---|---|---|
| 4.5MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 3.75MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 0.375MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 0.75MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 1.5MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 2.25MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
| 3MG | tablet, extended release | Discontinued | ORAL | N/A | Feb 6, 2014 |
22. NOVAST LABS
Novast Laboratories Ltd has filed for 7 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Novast Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 2.25MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 1.5MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 4.5MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 3.75MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
| 3MG | tablet, extended release | Prescription | ORAL | AB | Feb 3, 2022 |
23. XIAMEN LP PHARM CO
Xiamen Lp Pharmacuetical Co Ltd has filed for 2 different strengths of generic version for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Xiamen Lp Pharm Co.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.375MG | tablet, extended release | Prescription | ORAL | AB | Jun 11, 2021 |
| 0.75MG | tablet, extended release | Prescription | ORAL | AB | Jun 11, 2021 |