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Last Updated: December 5, 2022

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 Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Novast Labs, Sandoz Inc, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharma Avet, Mylan, Nostrum Labs Inc, Rising, Sandoz, 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-two patent family members in forty-four countries.

There are twenty-two drug master file entries for pramipexole dihydrochloride. Twenty-five 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
See Plans and PricingSee Plans and Pricing4.5MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing3MGTABLET, EXTENDED RELEASE;ORAL
See Plans and PricingSee Plans and Pricing1.5MGTABLET, 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 Class Nonergot 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
Sandoz Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202353-001 Dec 4, 2014 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Anchen Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-007 Feb 6, 2014 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Heritage Pharma Avet PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 078551-003 Oct 8, 2010 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Macleods Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 206156-002 Jun 24, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurobindo Pharma Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 202633-004 Oct 26, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Croatia P20100682 See Plans and Pricing
Eurasian Patent Organization 201001083 КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ЕЕ ПРИМЕНЕНИЕ See Plans and Pricing
Taiwan I351955 See Plans and Pricing
Israel 166080 See Plans and Pricing
Ukraine 86831 КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ДЕЙСТВИЯ, СОДЕРЖАЩЕЙ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ПРИМЕНЕНИЯ;КОМПОЗИЦІЯ ТАБЛЕТКИ ПРОЛОНГОВАНОГО ВИВІЛЬНЕННЯ, ЯКА МІСТИТЬ ПРАМІПЕКСОЛ АБО ЙОГО ФАРМАЦЕВТИЧНО ПРИЙНЯТНУ СІЛЬ, СПОСІБ ЇЇ ВИГОТОВЛЕННЯ ТА ЇЇ ЗАСТОСУВАННЯ (EXTENDED RELEASE TABLET FORMULATION COMPRISING PRAMIPEXOLE OR PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, METHOD FOR ITS MANUFACTURING AND ADMINISTRATION) See Plans and Pricing
>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 See Plans and Pricing 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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