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Last Updated: October 12, 2024

PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details


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What are the generic sources for pramipexole dihydrochloride and what is the scope of patent protection?

Pramipexole dihydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty-two 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-one patent family members in forty-four countries.

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

Summary for PRAMIPEXOLE DIHYDROCHLORIDE
Drug Prices for PRAMIPEXOLE DIHYDROCHLORIDE

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Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

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

SponsorPhase
Lund UniversityPhase 3
Region SkanePhase 3
Hoffmann-La RochePhase 1

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up3MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up1.5MGTABLET, EXTENDED RELEASE;ORAL
⤷  Sign Up⤷  Sign Up0.75MGTABLET, 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
Anatomical Therapeutic Chemical (ATC) Classes for PRAMIPEXOLE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 2.25 mg and 3.75 mg 022421 1 2011-07-26
MIRAPEX ER Extended-release Tablets pramipexole dihydrochloride 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg 022421 1 2010-06-01
MIRAPEX Tablets pramipexole dihydrochloride 0.75 mg 020667 1 2008-07-31
MIRAPEX Tablets pramipexole dihydrochloride 0.125 mg, 0.5 mg, 1 mg and 1.5 mg 020667 1 2005-06-24
MIRAPEX Tablets pramipexole dihydrochloride 0.25 mg 020667 1 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
Actavis Elizabeth PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 201963-004 Apr 21, 2016 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202891-001 Dec 12, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Endo Operations PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-002 Feb 6, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zydus Pharms Usa Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078920-001 Jul 6, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

International Patents for PRAMIPEXOLE DIHYDROCHLORIDE

Country Patent Number Title Estimated Expiration
China 101005831 Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof ⤷  Sign Up
Uruguay 27913 FORMA DE DOSIFICACION UNA VEZ AL DIA DE PRAMIPEXOL ⤷  Sign Up
Japan 2008509194 ⤷  Sign Up
Eurasian Patent Organization 201001083 КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ⤷  Sign Up
Iceland 7623 Sískammtalausnar töflusamsetning úr pramipexóli ⤷  Sign Up
South Korea 20050062516 SUSTAINED-RELEASE TABLET COMPOSITION OF PRAMIPEXOLE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 SPC/GB98/017 United Kingdom ⤷  Sign Up 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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