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Last Updated: March 29, 2024

Pramipexole dihydrochloride - Generic Drug Details


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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, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Generics, Heritage Pharma Avet, Mylan, 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
Region SkanePhase 3
Lund UniversityPhase 3
Clinical Academic Center (2CA-Braga)Phase 2

See all pramipexole dihydrochloride clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial4.5MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a Trial3MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try a Trial⤷  Try a 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
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
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Anchen Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-005 Feb 6, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zennova PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090151-006 Apr 30, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 pramipexole dihydrochloride TABLET;ORAL 020667-002 Jul 1, 1997 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-007 Jul 30, 2007 ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim MIRAPEX pramipexole dihydrochloride TABLET;ORAL 020667-005 Jul 1, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pramipexole dihydrochloride

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2004011002 ⤷  Try a Trial
Eurasian Patent Organization 200700201 КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ЕЕ ПРИМЕНЕНИЕ ⤷  Try a Trial
Spain 2421787 ⤷  Try a Trial
>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 ⤷  Try a 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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