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Pramipexole dihydrochloride - Generic Drug Details

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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 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.

This ingredient has two hundred and forty-five patent family members in forty-nine countries.

There are twenty-four drug master file entries for pramipexole dihydrochloride. Thirty-three 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 / Packaging: see list33
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: pramipexole dihydrochloride

Tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET, EXTENDED RELEASE;ORAL3.75MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Macleods Pharms Ltd
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL202164-002Sep 20, 2012RXNo► subscribe► subscribe
Breckenridge Pharm
PRAMIPEXOLE DIHYDROCHLORIDE
pramipexole dihydrochloride
TABLET;ORAL091450-003Oct 8, 2010RXNo► subscribe► subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 2010RXNo7,695,734► subscribeY ► subscribe
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Expired Orange Book Patents for Generic Ingredient: pramipexole dihydrochloride

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-004Feb 19, 20104,886,812► subscribe
Boehringer Ingelheim
MIRAPEX
pramipexole dihydrochloride
TABLET;ORAL020667-002Jul 1, 19974,886,812► subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-003Feb 19, 20104,886,812► 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
New Zealand553561► subscribe
Poland375696► subscribe
Norway20050481► 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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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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