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Serving leading biopharmaceutical companies globally:

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Generated: December 16, 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 Boehringer Ingelheim, Actavis Elizabeth, Anchen Pharms, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Sandoz Inc, Actavis Grp Ptc, Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Barr, Breckenridge Pharm, Glenmark Generics, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Teva Pharms, Torrent Pharms, Watson Labs, and Zydus Pharms Usa Inc, 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 sixty-seven patent family members in fifty countries and one supplementary protection certificate in one country.

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

Pharmacology for pramipexole dihydrochloride

Tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► Subscribe0.375MGTABLET, EXTENDED RELEASE;ORAL
u► Subscribe4.5MGTABLET, EXTENDED RELEASE;ORAL
u► 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
Sun Pharm Inds IncPRAMIPEXOLE DIHYDROCHLORIDEpramipexole dihydrochlorideTABLET;ORAL091683-003Mar 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-006Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY► Subscribe
Macleods Pharms LtdPRAMIPEXOLE DIHYDROCHLORIDEpramipexole dihydrochlorideTABLET;ORAL202164-005Sep 20, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-006Jun 17, 2011ABRXYesNo► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-007Jul 30, 2007ABRXYesNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Macleods Pharms LtdPRAMIPEXOLE DIHYDROCHLORIDEpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL206156-005Jun 24, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010ABRXYesNo► Subscribe► SubscribeY► 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 IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-006Feb 12, 1998► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 2010► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-002Jul 1, 1997► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-005Jul 1, 1997► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-001Jul 1, 1997► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 2010► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-007Jul 30, 2007► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-003Jul 1, 1997► Subscribe► Subscribe
Boehringer IngelheimMIRAPEXpramipexole dihydrochlorideTABLET;ORAL020667-004Jul 1, 1997► Subscribe► Subscribe
Boehringer IngelheimMIRAPEX ERpramipexole dihydrochlorideTABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 2010► 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
Canada2493179► Subscribe
MontenegroP52208► Subscribe
Poland375444► Subscribe
Eurasian Patent Organization201001083► Subscribe
Hong Kong1077753► Subscribe
Russian Federation2292873► Subscribe
Japan4757872► Subscribe
South Africa200700085► Subscribe
China1117564► Subscribe
Australia2011250676► 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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Serving leading biopharmaceutical companies globally:

Fuji
Cipla
UBS
Federal Trade Commission
Colorcon
Citi
McKesson
Boehringer Ingelheim
Baxter
Johnson and Johnson

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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