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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Queensland Health
Daiichi Sankyo
Citi
Medtronic
Colorcon
Julphar
Harvard Business School
UBS

Generated: August 23, 2017

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Pramipexole dihydrochloride - Generic Drug Details

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

Pramipexole dihydrochloride
is the generic ingredient in three branded drugs marketed by Strides Pharma, Anchen Pharms, Actavis Elizabeth, Zydus Pharms Usa Inc, Boehringer Ingelheim, Barr, Aurobindo Pharma Ltd, Teva Pharms, Breckenridge Pharm, Apotex Inc, Watson Labs, Sandoz Inc, Dr Reddys Labs Ltd, Actavis Grp Ptc, Mylan, Sciegen Pharms Inc, Macleods Pharms Ltd, Torrent Pharms, Glenmark Generics, Sun Pharm Inds Inc, Sandoz, and Alembic Pharms Ltd, and is included in twenty-six NDAs. There are four 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 fifty patent family members in forty-nine countries.

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

Summary for Generic Name: pramipexole dihydrochloride

Tradenames:3
Patents:4
Applicants:22
NDAs:26
Drug Master File Entries: see list24
Suppliers / Packagers: see list31
Bulk Api Vendors: see list139
Clinical Trials: see list155
Patent Applications: see list5,884
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pramipexole dihydrochloride at DailyMed

Pharmacology for Ingredient: pramipexole dihydrochloride

Tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.375MGTABLET, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe4.5MGTABLET, EXTENDED RELEASE;ORAL
► Subscribe► Subscribe3MGTABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL078551-002Oct 8, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL203354-002Aug 7, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-003Jul 1, 1997ABRXYesNo► Subscribe► Subscribe ► Subscribe
Teva Pharms
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL090241-005Oct 8, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL090241-003Oct 8, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: pramipexole dihydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-003Jul 1, 1997► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-002Jul 1, 1997► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 2010► Subscribe► Subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-005Jul 1, 1997► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: pramipexole dihydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,377,977Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof► Subscribe
8,399,016Sustained-release tablet composition of pramipexole► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: pramipexole dihydrochloride

Country Document Number Estimated Expiration
Japan2009185051► Subscribe
New Zealand562681► Subscribe
Eurasian Patent Organization200900930► Subscribe
Cyprus1114263► Subscribe
Canada2492854► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: PRAMIPEXOLE DIHYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB98/017United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Express Scripts
Fuji
Cerilliant
US Army
Fish and Richardson
Teva
UBS
Colorcon
Argus Health
US Department of Justice

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.

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