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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 in its drug Mirapex on Jul 1, 1997. Another drug containing Pramipexole Dihydrochloride is Mirapex Er. 25 different companies have introduced drugs containing Pramipexole Dihydrochloride.


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 Er US8679533 Pramipexole once-daily dosage form Sep 08, 2029 Boehringer Ingelheim
Mirapex Er US7695734 Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof Apr 26, 2028 Boehringer Ingelheim
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



Pramipexole Dihydrochloride's Family Patents

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Pramipexole Dihydrochloride Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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


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





2. 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


Manufacturing Plant Locations
New

Alembic'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 Alembic as present at those locations.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)





3. 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


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





4. 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





5. 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

(reference standard)

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





6. 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





7. 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





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. 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





10. NATCO

Natco Pharma 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 Natco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
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


Manufacturing Plant Locations
New

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

Country City Firm Name
United Kingdom
Buckingham Natco Foods Ltd
Hayes Natco Cash and Carry
India
Hyderabad NATCO PHARMA LTD
Paravada Natco Pharma Limited
Hyderabad Natco Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai
Rangareddy District Natco Pharma Ltd. - Chemical Division
Rangareddy NATCO Pharma Limited





11. NATCO PHARMA

Natco Pharma Ltd has filed for 1 generic for Pramipexole Dihydrochloride. Given below are the details of the strengths of this generic introduced by Natco Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.75MG

tablet Discontinued ORAL N/A Apr 9, 2010


Manufacturing Plant Locations
New

Natco 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 Natco Pharma as present at those locations.

Country City Firm Name
India
Hyderabad NATCO PHARMA LTD
Paravada Natco Pharma Limited
Hyderabad Natco Pharma Limited
Chennai NATCO Pharma Limited Chemical Division Chennai
Rangareddy District Natco Pharma Ltd. - Chemical Division
Rangareddy NATCO Pharma Limited





12. 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





13. 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





14. 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


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





15. 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


Manufacturing Plant Locations
New

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

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
Princeton Sandoz Inc
East Hanover Sandoz Incorporated
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





16. 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





17. 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


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
Bangalore Strides Pharma Science Limited
Puducherry Strides Pharma Science Limited





18. 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





19. 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





20. 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


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





21. 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





22. 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





23. 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





24. 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