Mirapex ER Drug Patent Profile
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Which patents cover Mirapex Er, and what generic alternatives are available?
Mirapex Er is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
This drug has two hundred and thirty-one patent family members in forty-four countries.
The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mirapex Er
A generic version of Mirapex ER was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.
Summary for Mirapex ER
International Patents: | 231 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 32 |
Patent Applications: | 1,958 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Mirapex ER |
DailyMed Link: | Mirapex ER at DailyMed |
![Mirapex ER drug patent expirations Drug patent expirations by year for Mirapex ER](/p/graph/s/t/Mirapex_ER-patent-expirations.png)
![Drug Prices for Mirapex ER](/p/graph/drug-price/Mirapex+ER.png)
See drug prices for Mirapex ER
![Drug Sales Revenue Trends for Mirapex ER](/p/graph/drug-sales-revenues/Mirapex+ER.png)
Recent Clinical Trials for Mirapex ER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Massachusetts General Hospital | Phase 2/Phase 3 |
University of New Mexico Clinical and Translational Science Center | Early Phase 1 |
University of New Mexico | Early Phase 1 |
Pharmacology for Mirapex ER
Drug Class | Nonergot Dopamine Agonist |
Mechanism of Action | Dopamine Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for Mirapex ER
Paragraph IV (Patent) Challenges for MIRAPEX ER
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 |
US Patents and Regulatory Information for Mirapex ER
Mirapex ER is protected by two US patents.
Patents protecting Mirapex ER
Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Pramipexole once-daily dosage form
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PARKINSON'S DISEASE
Expired US Patents for Mirapex ER
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-001 | Feb 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-005 | Feb 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-003 | Feb 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-002 | Feb 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-004 | Feb 19, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Mirapex ER
See the table below for patents covering Mirapex ER around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Mexico | PA05001056 | COMPRIMIDO DE LIBERACION SOSTENIDA QUE COMPRENDE REBOXETINA. (SUSTAINED-RELEASE TABLET COMPRISING REBOXETINE.) | ⤷ Try a Trial |
Ireland | 58863 | Tetrahydro-benzthiazoles | ⤷ Try a Trial |
Brazil | 0312891 | Composição em comprimidos de liberação controlada compreendendo um agonista do receptor de dopamina | ⤷ Try a Trial |
Denmark | 1531814 | ⤷ Try a Trial | |
Spain | 556874 | ⤷ Try a Trial | |
Norway | 20050093 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Mirapex ER
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0186087 | SPC/GB98/017 | United Kingdom | ⤷ Try a Trial | 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 |
0186087 | C980002 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PRAMIPEXOL, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT, IN HET BIJZONDER PRAMIPEXOL-DIHYDROCHLORIDE-MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/97/050/001 - EU/1/97/050/010 19971014 |
0186087 | 98C0013 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |