Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Merck
Boehringer Ingelheim
Johnson and Johnson
Baxter

Last Updated: November 14, 2019

DrugPatentWatch Database Preview

Pramipexole dihydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for pramipexole dihydrochloride and what is the scope of freedom to operate?

Pramipexole dihydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, 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, Teva Pharms, Torrent Pharms, Unichem Labs Ltd, and Zydus Pharms Usa Inc, and is included in thirty NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pramipexole dihydrochloride has two hundred and thirty patent family members in forty-four countries.

There are twenty-five drug master file entries for pramipexole dihydrochloride. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for pramipexole dihydrochloride

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

SponsorPhase
University Hospital, Strasbourg, FrancePhase 2
Second Affiliated Hospital of Soochow UniversityPhase 4
University of New MexicoEarly Phase 1

See all pramipexole dihydrochloride clinical trials

Recent Litigation for pramipexole dihydrochloride

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 pramipexole dihydrochloride litigation

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial4.5MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial3MGTABLET, EXTENDED RELEASE;ORAL
  Start Trial  Start Trial1.5MGTABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for pramipexole dihydrochloride
Drug ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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
Apotex Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090151-004 Apr 30, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090241-005 Oct 8, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Dr Reddys PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 203354-001 Aug 7, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202702-002 Jun 3, 2014 AB RX No 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 pramipexole dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-004 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-004 Jul 1, 1997   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 020667-003 Jul 1, 1997   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for pramipexole dihydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
Dow
Colorcon
Harvard Business School
Express Scripts
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.