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Last Updated: April 5, 2020

DrugPatentWatch Database Preview

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.

Drug patent expirations by year for MIRAPEX
Drug Prices for MIRAPEX

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Drug Sales Revenue Trends for MIRAPEX

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Recent Clinical Trials for MIRAPEX

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SponsorPhase
University of New Mexico Clinical and Translational Science CenterEarly Phase 1
University of New MexicoEarly Phase 1
Icahn School of Medicine at Mount SinaiPhase 4

See all MIRAPEX clinical trials

Recent Litigation for MIRAPEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
Edwards Lifesciences AG v. CoreValve, Inc.2014-04-14
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.2006-05-02
Sunovion Pharmaceuticals v. Dey Pharma2006-02-22

See all MIRAPEX litigation

Pharmacology for MIRAPEX
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-007 Jun 17, 2011 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 AB RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 AB RX Yes 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

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

Supplementary Protection Certificates for MIRAPEX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 98C0013 Belgium   Start Trial PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014
0186087 C980002 Netherlands   Start Trial 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   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Express Scripts
Dow
Merck
Harvard Business School

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