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MIRAPEX Drug Profile

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When do Mirapex patents expire, and what generic alternatives are available?

Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are two patents protecting this drug and five Paragraph IV challenges.

The generic ingredient in MIRAPEX 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 Mirapex

A generic version of MIRAPEX was approved as pramipexole dihydrochloride by HERITAGE PHARMA on February 19^th, 2008.

Summary for MIRAPEX

US Patents:	0
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	219
Clinical Trials:	29
Patent Applications:	4,131
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MIRAPEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MIRAPEX
DailyMed Link:	MIRAPEX at DailyMed

See drug prices for MIRAPEX

See drug sales revenues for MIRAPEX

Recent Clinical Trials for MIRAPEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of New Mexico Clinical and Translational Science Center	Early Phase 1
University of New Mexico	Early Phase 1
Icahn School of Medicine at Mount Sinai	Phase 4

See all MIRAPEX clinical trials

Recent Litigation for MIRAPEX

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 MIRAPEX litigation

Pharmacology for MIRAPEX

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

Synonyms for MIRAPEX

(-) Pramipexole

(-)-Pramipexole

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

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

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

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

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

(6S)-N(6)-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 hydrate

(6S)-N~6~-Propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine--hydrogen chloride--water (1/2/1)

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

(6S)-N6-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 hydrate dihydrochloride

(s)-(-)-2-amino-6-n-propylamino-4,5,6,7-tetrahydrobenzothiazole

(S)-2-Amino-4,5,6,7-tetrahydro-6-(p ropylamino)benzothiazole dihydrochloride

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

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

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

(S)-2-amino-4,5,6,7-tetrahydro-6-(propylaMino)benzothiazole dihydrochloride Monohydrate;(S)-2-amino-4,5,6,7-tetrahydro-6-(propylaMino)benzothiazole dihydrochloride Monohydrate

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

(s)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzothiazole

(S)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzthiazole;(S)-2-amino-6-propylamino-4,5,6,7-tetrahydrobenzthiazole

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

(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

(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 hydrate

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

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

(S)-Pramipexole

(S)-Pramipexole Dihydrochloride

1-(4-Fluorophenyl)-4-[4-(2-pyridinyl)-1-piperaziny

104632-25-9

104632-26-0

111GE001

112GI013

112GI018

191217-81-9

191712-81-9

2-amino-4,5,6,7-tetrahydro-6-propylaminobenzothiazole

2-amino-6-propylaminotetrahydrobenzothiazole

2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N(sup 6)-propyl-, (S)-

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

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

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, monohydrate, (6S)-

2,6-Benzothiazolediamine, 4,5,6,7-tetrahydro-N6-propyl-, hydrochloride, hydrate (1:2:1), (6S)-

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

2,6-Benzothiazolediamine,4,5,6,7-tetrahydro-N6-propyl-dihydrochloride,monohydrate

3D867NP06J

4R2HD0M28N

632P259

632P260

83619PEU5T

A801025

AB00053772_14

AB00053772_16

AB00053772-12

AB00053772-13

AB0020076

AB0055235

AB2000420

AB2000575

AC-1040

AK-79154

AKOS005145770

AKOS015844953

AKOS015917338

AKOS016843188

ANW-57521

ANW-64032

API0005552

APVQOOKHDZVJEX-QTPLPEIMSA-N

B1488

BDBM50116766

BG0440

BI-Sifrol

BIDD:GT0250

C10H17N3S.2HCl

C10H17N3S.2HCl.H2O

C10H19Cl2N3S

CAS-104632-26-0

CAS-191217-81-9

CCG-100823

CCG-220987

CCG-222342

CHEBI:51147

CHEBI:51148

CHEBI:8356

CHEMBL301265

CHEMBL3143955

CHEMBL3182733

CPD000449298

CS-0890

CS-2510

CTK8B7511

CTK8C0068

CTK8E7913

CX1349

D00559

D05575

DB-038042

DB00413

DivK1c_006916

DS-14807

DSSTox_CID_24227

DSSTox_CID_3496

DSSTox_GSID_23496

DSSTox_GSID_44227

DSSTox_RID_77054

DSSTox_RID_80129

DTXSID1044227

DTXSID6023496

DTXSID90146623

EC 600-593-1

FASDKYOPVNHBLU-ZETCQYMHSA-N

FD7210

FT-0082223

FT-0601705

FT-0602102

FT-0651622

GS-3583

GTPL953

H32P260

HMS2051A21

HMS2090C15

HMS2232B03

HSDB 8253

HY-17355

HY-B0410

J-001210

J-001211

J-012354

J-524051

K-0425

K-5698

KBio1_001860

KBio2_002340

KBio2_004908

KBio2_007476

KBioSS_002343

KS-00000A3W

KS-00000GZ2

KS-00000XK2

KS-1308

KS-5081

LS-182448

LS-40722

LS-40723

MFCD00876894

Mirapex (TN)

Mirapex ER

Mirapex LA

Mirapexin

Mirapexin;Sifrol;Mirapex

MLS000758250

MLS001423952

NC00073

NCGC00167441-01

NCGC00167441-02

NCGC00167441-03

NCGC00255978-01

Oprymea

P2073

PNU 98528E

PNU-98528E

PPX dihydrochloride

Pramipexol

Pramipexol [Spanish]

pramipexole

Pramipexole hydrochloride

Pramipexole (dihydrochloride)

Pramipexole (Mirapex)

Pramipexole (USAN/INN)

Pramipexole [USAN:INN:BAN]

Pramipexole [USAN:INN]

PRAMIPEXOLE 2HCL

Pramipexole 2HCl Monohydrate

Pramipexole Base

Pramipexole diHCl

Pramipexole DiHCl monohydrate

Pramipexole dihydrochloride

Pramipexole dihydrochloride [USAN:USP]

Pramipexole dihydrochloride [USAN]

Pramipexole Dihydrochloride Anhydrous

Pramipexole dihydrochloride hydrate

Pramipexole dihydrochloride monohydrate

Pramipexole dihydrochloride, >98% (HPLC), powder

Pramipexole HCl hydrate

pramipexole hydrate dihydrochloride

PRAMIPEXOLE HYDROCHLORIDE

Pramipexole hydrochloride (USAN)

pramipexole hydrochloride anhydrous

Pramipexole hydrochloride hydrate

Pramipexole hydrochloride hydrate (JAN)

Pramipexole Teva

Pramipexole-dihydrochloride-monohydrate

Pramipexole-Mirapex

Pramipexole, PPX

Pramipexolum

Pramipexolum [Latin]

Q27122451

Q27888021

Q421304

QMNWXHSYPXQFSK-KLXURFKVSA-N

RT-015127

RT-015572

RTC-070954

s2011

s2460

s5066

SAM001247006

SC-20191

SC-46343

SC-79550

SCHEMBL35376

SCHEMBL42113

Sifrol

SMR000449298

SND 919

SND 9192CL2Y

SND-919

SND-919CL2Y

SND-919Y

SND919CL2Y

SpecPlus_000820

Spectrum_001838

Spectrum5_001453

SR-01000763219

SR-01000763219-5

SR-01000763219-6

ST2402883

ST24036373

ST24049029

SUD 919CL2Y

SUD-919CL2Y

SUD919CL2Y

SW197453-4

SW197453-5

TC-070954

Tox21_112445

Tox21_112445_1

Tox21_302316

U-98528E

UNII-3D867NP06J

UNII-4R2HD0M28N

UNII-83619PEU5T

V0817

W-5189

ZINC3781664

Paragraph IV (Patent) Challenges for MIRAPEX

Tradename	Dosage	Ingredient	NDA	Submissiondate
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 MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-001	Jul 1, 1997	AB	RX	Yes	No
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011	AB	RX	Yes	No			Y
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997	AB	RX	Yes	No
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007	AB	RX	Yes	No

Expired US Patents for MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-006	Feb 12, 1998
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-001	Jul 1, 1997

International Patents for MIRAPEX

Country	Patent Number	Estimated Expiration
Spain	556874
Denmark	0989850
Portugal	989850
Slovenia	0989850

Supplementary Protection Certificates for MIRAPEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	98C0013	Belgium		PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
0186087	C980002	Netherlands		PRODUCT NAME: PRAMIPEXOL, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER PRAMIPEXOL-DIHYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/97/050/001 - EU/1/97/050/010 19971014
0186087	SPC/GB98/017	United Kingdom		PRODUCT NAME: PRAMIPEXOLE, OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT, IN PARTICULAR PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE; REGISTERED: UK EU/1/97/050/001 19971014; UK EU/1/97/050/002 19971014; UK EU/1/97/050/003 19971014; UK EU/1/97/050/004 19971014; UK EU/1/97/050/005 19971014; UK EU/1/97/050/006 19971014; UK EU/1/97/050/007 19971014; UK EU/1/97/050/008 19971014; UK EU/1/97/050/009 19971014; UK EU/1/97/050/010 19971014