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PRAMIPEXOLE DIHYDROCHLORIDE Drug Profile
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When do Pramipexole Dihydrochloride patents expire, and what generic alternatives are available?
Pramipexole Dihydrochloride is a drug marketed by Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Glenmark Generics, Heritage Pharma, Mylan, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc. and is included in twenty-eight NDAs.
The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Pramipexole Dihydrochloride
A generic version of PRAMIPEXOLE DIHYDROCHLORIDE was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.
Summary for PRAMIPEXOLE DIHYDROCHLORIDE
US Patents: | 0 |
Applicants: | 21 |
NDAs: | 28 |
Suppliers / Packagers: | 23 |
Bulk Api Vendors: | 87 |
Clinical Trials: | 114 |
Patent Applications: | 1,441 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for PRAMIPEXOLE DIHYDROCHLORIDE |
DailyMed Link: | PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed |


Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hongguan biological pharmaceutical co. | N/A |
First Affiliated Hospital of Zhejiang University | N/A |
United States Department of Defense | Phase 1 |
Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE
Drug Class | Nonergot Dopamine Agonist |
Mechanism of Action | Dopamine Agonists |
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
MIRAPEX ER | TABLET, EXTENDED RELEASE;ORAL | pramipexole dihydrochloride | 022421 | 2011-07-26 |
MIRAPEX ER | TABLET, EXTENDED RELEASE;ORAL | pramipexole dihydrochloride | 022421 | 2010-06-01 |
MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 2008-07-31 |
MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 2005-06-24 |
MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 2005-05-27 |