You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
McKinsey
AstraZeneca
Baxter
Dow

Last Updated: February 19, 2020

DrugPatentWatch Database Preview

PRAMIPEXOLE DIHYDROCHLORIDE Drug Profile


Email this page to a colleague

See Plans and Pricing

« Back to Dashboard

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 19th, 2008.

  Start Trial

Drug patent expirations by year for PRAMIPEXOLE DIHYDROCHLORIDE
Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

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

SponsorPhase
East Carolina UniversityPhase 1/Phase 2
Region SkanePhase 2
Lund UniversityPhase 2

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

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
Cspc Ouyi PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 211088-005 Oct 3, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202164-001 Sep 20, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202891-003 Dec 12, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156-007 Jan 23, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Heritage Pharma PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091254-002 Nov 30, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090190-003 Jul 6, 2010 DISCN 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

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

Serving leading biopharmaceutical companies globally:

Colorcon
Baxter
Moodys
AstraZeneca
Merck
Express Scripts

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.