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Pramipexole dihydrochlorideis the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms, Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharma, 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 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-five 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 Master File Entries:||25|
|Finished Product Suppliers / Packagers:||24|
|Raw Ingredient (Bulk) Api Vendors:||89|
|Formulation / Manufacturing:||see details|
|Drug Prices:||Drug price trends for PRAMIPEXOLE DIHYDROCHLORIDE|
|What excipients (inactive ingredients) are in PRAMIPEXOLE DIHYDROCHLORIDE?||PRAMIPEXOLE DIHYDROCHLORIDE excipients list|
|DailyMed Link:||PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed|
Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
|Massachusetts General Hospital||Phase 2/Phase 3|
|First Affiliated Hospital of Zhejiang University||N/A|
|Hongguan biological pharmaceutical co.||N/A|
Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
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 Action||Dopamine Agonists |
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
|MIRAPEX ER||TABLET, EXTENDED RELEASE;ORAL||pramipexole dihydrochloride||022421||2011-07-26|
|MIRAPEX ER||TABLET, EXTENDED RELEASE;ORAL||pramipexole dihydrochloride||022421||2010-06-01|
|Country||Patent Number||Estimated Expiration|
|Canada||2492424||⤷ Try it Free|
|Serbia||115104||⤷ Try it Free|
|Spain||2421787||⤷ Try it Free|
|Eurasian Patent Organization||016850||⤷ Try it Free|
|Denmark||1781260||⤷ Try it Free|
|Russian Federation||2005101639||⤷ Try it Free|
|Panama||8578301||⤷ Try it Free|
|>Country||>Patent Number||>Estimated Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0186087||SPC/GB98/017||United Kingdom||⤷ Try it Free||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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