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Last Updated: January 17, 2021

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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.

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Drug patent expirations by year for PRAMIPEXOLE DIHYDROCHLORIDE
Drug Prices for PRAMIPEXOLE DIHYDROCHLORIDE

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Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

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SponsorPhase
Hongguan biological pharmaceutical co.N/A
First Affiliated Hospital of Zhejiang UniversityN/A
United States Department of DefensePhase 1

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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

US Patents and Regulatory Information for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heritage Pharma PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 077724-002 Feb 19, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Rising PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 211088-001 Oct 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202891-003 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156-007 Jan 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 077724-005 Feb 19, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 203855-003 Oct 28, 2014 AB RX No No   Start Trial   Start Trial   Start Trial
Unichem PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 207011-006 Dec 19, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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