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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, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms Usa Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr, Breckenridge Pharm, Glenmark Generics, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Teva Pharms, Torrent Pharms, and Watson Labs. and is included in twenty-five NDAs.

The generic ingredient in PRAMIPEXOLE DIHYDROCHLORIDE is pramipexole dihydrochloride. There are twenty-four drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for PRAMIPEXOLE DIHYDROCHLORIDE

US Patents:	0
Applicants:	21
NDAs:	25
Suppliers / Packagers:	28
Bulk Api Vendors:	71
Clinical Trials:	100
Patent Applications:	1,277
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PRAMIPEXOLE DIHYDROCHLORIDE
DailyMed Link:	PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed

Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE

Drug Class	Nonergot Dopamine Agonist Serotonin Reuptake Inhibitor
Mechanism of Action	Dopamine Agonists Serotonin Uptake Inhibitors

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)-

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

MFCD00876894

Mirapex

Mirapex ER

Mirapex LA

Mirapexin;Sifrol;Mirapex

MolPort-005-938-249

P2073

PNU-98528E

PPX dihydrochloride

Pramipexole hydrochloride

Pramipexole (dihydrochloride)

PRAMIPEXOLE 2HCL

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

ST51051315

TC-070954

UNII-4R2HD0M28N

V0817

W-5189

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
Glenmark Generics	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	090781-001	Oct 8, 2010	AB	RX	No	No
Strides Pharma	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	202702-001	Jun 3, 2014	AB	RX	No	No
Actavis Grp Ptc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET;ORAL	091254-003	Nov 30, 2010		DISCN	No	No
Zydus Pharms Usa Inc	PRAMIPEXOLE DIHYDROCHLORIDE	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	202891-001	Dec 12, 2017	AB	RX	No	No

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