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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, Apotex Inc, Aurobindo Pharma Ltd, Breckenridge Pharm, Cspc Ouyi, Glenmark Generics, Heritage Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem Labs Ltd, 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-two 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 HERITAGE PHARMA on February 19^th, 2008.

Summary for PRAMIPEXOLE DIHYDROCHLORIDE

US Patents:	0
Applicants:	21
NDAs:	28
Suppliers / Packagers:	21
Bulk Api Vendors:	80
Clinical Trials:	112
Patent Applications:	1,412
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
East Carolina University	Phase 1/Phase 2
Region Skane	Phase 2
Lund University	Phase 2

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Recent Litigation for PRAMIPEXOLE DIHYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Edwards Lifesciences AG v. CoreValve, Inc.	2014-04-14
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.	2006-05-02
Sunovion Pharmaceuticals v. Dey Pharma	2006-02-22

See all PRAMIPEXOLE DIHYDROCHLORIDE litigation

Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Synonyms for PRAMIPEXOLE DIHYDROCHLORIDE

(6S)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride

(6S)-N(6)-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride

(6S)-N6-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine dihydrochloride

(S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride

(S)-N6-Propyl-4,5,6,7-tetrahydrobenzo[d]-thiazole-2,6-diamine dihydrochloride

(S)-N6-Propyl-4,5,6,7-tetrahydrobenzo[d]thiazole-2,6-diamine dihydrochloride

(S)-N6-Propyl-4,5,6,7-tetrahydrobenzothiazole-2,6-diamine Dihydrochloride

(S)-Pramipexole Dihydrochloride

104632-25-9

112GI018

2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-, dihydrochloride, (6S)-

2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-, dihydrochloride, (S)-

2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-,dihydrochloride, (6S)-

4R2HD0M28N

632P259

AB0020076

AB2000575

AC-1040

AC1L3P1Q

AK-79154

AKOS005145770

AKOS015844953

AN-15614

ANW-57521

API0005552

BC215599

BG0440

BI-Sifrol

C10H19Cl2N3S

CCG-220987

CCG-222342

CHEBI:51148

CHEMBL3143955

CS-0890

CTK8B7511

DTXSID90146623

FD7210

FT-0601705

GS-3583

H32P260

HY-17355

J-001210

J-524051

KS-00000GZ2

KS-5081

LS-182448

Mirapex

Mirapex ER

Mirapex LA

Mirapexin;Sifrol;Mirapex

MolPort-005-938-249

P2073

PPX dihydrochloride

Pramipexole hydrochloride

Pramipexole (dihydrochloride)

PRAMIPEXOLE 2HCL

Pramipexole diHCl

Pramipexole dihydrochloride [USAN]

Pramipexole dihydrochloride, >98% (HPLC), powder

PRAMIPEXOLE HYDROCHLORIDE

pramipexole hydrochloride anhydrous

QMNWXHSYPXQFSK-KLXURFKVSA-N

RTC-070954

SC-20191

SC-79550

SCHEMBL42113

SND-919CL2Y

SND-919Y

ST2402883

TC-070954

UNII-4R2HD0M28N

V0817

W-5189

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
Cspc Ouyi	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	211088-005	Oct 3, 2018	AB	RX	No	No
Macleods Pharms Ltd	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	202164-001	Sep 20, 2012	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	091254-002	Nov 30, 2010		DISCN	No	No
Sandoz	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090190-003	Jul 6, 2010		DISCN	No	No