PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details
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What are the generic sources for pramipexole dihydrochloride and what is the scope of patent protection?
Pramipexole dihydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Alembic, Dr Reddys, Endo Operations, Macleods Pharms Ltd, Novast Labs, Sandoz, Xiamen Lp Pharm Co, Zydus Pharms, Aurobindo Pharma Ltd, Chartwell Rx, Glenmark Pharms Ltd, Heritage Pharma Avet, Natco, Natco Pharma, Nostrum Labs Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, Zennova, and Zydus Pharms Usa Inc, and is included in thirty-two 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-one patent family members in forty-four countries.
There are twenty-two 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
International Patents: | 231 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 25 |
NDAs: | 32 |
Drug Master File Entries: | 22 |
Finished Product Suppliers / Packagers: | 24 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 121 |
Patent Applications: | 2,944 |
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
Sponsor | Phase |
---|---|
Lund University | Phase 3 |
Region Skane | Phase 3 |
Hoffmann-La Roche | Phase 1 |
Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 3MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 1.5MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 0.75MG | TABLET, EXTENDED RELEASE;ORAL |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for PRAMIPEXOLE DIHYDROCHLORIDE
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
MIRAPEX ER | Extended-release Tablets | pramipexole dihydrochloride | 2.25 mg and 3.75 mg | 022421 | 1 | 2011-07-26 |
MIRAPEX ER | Extended-release Tablets | pramipexole dihydrochloride | 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg | 022421 | 1 | 2010-06-01 |
MIRAPEX | Tablets | pramipexole dihydrochloride | 0.75 mg | 020667 | 1 | 2008-07-31 |
MIRAPEX | Tablets | pramipexole dihydrochloride | 0.125 mg, 0.5 mg, 1 mg and 1.5 mg | 020667 | 1 | 2005-06-24 |
MIRAPEX | Tablets | pramipexole dihydrochloride | 0.25 mg | 020667 | 1 | 2005-05-27 |
US Patents and Regulatory Information for PRAMIPEXOLE DIHYDROCHLORIDE
Expired US Patents for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRAMIPEXOLE DIHYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 101005831 | Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof | ⤷ Sign Up |
Uruguay | 27913 | FORMA DE DOSIFICACION UNA VEZ AL DIA DE PRAMIPEXOL | ⤷ Sign Up |
Japan | 2008509194 | ⤷ Sign Up | |
Eurasian Patent Organization | 201001083 | КОМПОЗИЦИЯ ТАБЛЕТКИ ПРОЛОНГИРОВАННОГО ВЫСВОБОЖДЕНИЯ, СОДЕРЖАЩАЯ ПРАМИПЕКСОЛ ИЛИ ЕГО ФАРМАЦЕВТИЧЕСКИ ПРИЕМЛЕМУЮ СОЛЬ, СПОСОБ ЕЕ ИЗГОТОВЛЕНИЯ И ЕЕ ПРИМЕНЕНИЕ | ⤷ Sign Up |
Iceland | 7623 | Sískammtalausnar töflusamsetning úr pramipexóli | ⤷ Sign Up |
South Korea | 20050062516 | SUSTAINED-RELEASE TABLET COMPOSITION OF PRAMIPEXOLE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0186087 | SPC/GB98/017 | United Kingdom | ⤷ Sign Up | 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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