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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 6^th, 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

See drug prices for PRAMIPEXOLE DIHYDROCHLORIDE

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

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

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

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
Rising	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	211088-001	Oct 3, 2018	AB	RX	No	No
Zydus Pharms	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202891-003	Dec 12, 2017	AB	RX	No	No
Macleods Pharms Ltd	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	206156-007	Jan 23, 2017	AB	RX	No	No
Heritage Pharma	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	077724-005	Feb 19, 2008		DISCN	No	No
Sciegen Pharms Inc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	203855-003	Oct 28, 2014	AB	RX	No	No
Unichem	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	207011-006	Dec 19, 2018		DISCN	No	No