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Generated: April 29, 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 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 Ltd, and is included in twenty-six NDAs. There are five 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 forty-six patent family members in forty-nine countries.

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

Summary for Generic Name: pramipexole dihydrochloride

Drug Master File Entries: see list24
Suppliers / Packagers: see list32
Bulk Api Vendors: see list139
Clinical Trials: see list49
Patent Applications: see list5,644
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:pramipexole dihydrochloride at DailyMed

Pharmacology for Ingredient: pramipexole dihydrochloride


Applicant Application No. Form Dosage
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Strides Pharma
pramipexole dihydrochloride
TABLET;ORAL202702-003Jun 3, 2014ABRXNoNo► Subscribe► Subscribe
Strides Pharma
pramipexole dihydrochloride
TABLET;ORAL202702-005Jun 3, 2014ABRXNoNo► Subscribe► Subscribe
Teva Pharms
pramipexole dihydrochloride
TABLET;ORAL090241-005Oct 8, 2010ABRXNoNo► Subscribe► Subscribe
Boehringer Ingelheim
pramipexole dihydrochloride
TABLET;ORAL020667-001Jul 1, 1997ABRXYesNo6,194,445► Subscribe ► Subscribe
Actavis Elizabeth
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL203615-002Jan 3, 2017ABRXNoNo► Subscribe► Subscribe
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