MIRAPEX Drug Patent Profile
✉ Email this page to a colleague
When do Mirapex patents expire, and what generic alternatives are available?
Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are two patents protecting this drug and three Paragraph IV challenges.
The generic ingredient in MIRAPEX 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
A generic version of MIRAPEX was approved as pramipexole dihydrochloride by ZYDUS PHARMS USA INC on July 6th, 2010.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MIRAPEX?
- What are the global sales for MIRAPEX?
- What is Average Wholesale Price for MIRAPEX?
Summary for MIRAPEX
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 279 |
Clinical Trials: | 32 |
Patent Applications: | 29 |
Drug Prices: | Drug price information for MIRAPEX |
What excipients (inactive ingredients) are in MIRAPEX? | MIRAPEX excipients list |
DailyMed Link: | MIRAPEX at DailyMed |
Recent Clinical Trials for MIRAPEX
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Massachusetts General Hospital | Phase 2/Phase 3 |
University of New Mexico | Early Phase 1 |
University of New Mexico Clinical and Translational Science Center | Early Phase 1 |
Paragraph IV (Patent) Challenges for MIRAPEX
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
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 MIRAPEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-007 | Jun 17, 2011 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for MIRAPEX
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-003 | Jul 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MIRAPEX
See the table below for patents covering MIRAPEX around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 69827387 | ⤷ Sign Up | |
Australia | 583874 | ⤷ Sign Up | |
Netherlands | 980002 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIRAPEX
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0186087 | 98C0013 | Belgium | ⤷ Sign Up | PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014 |
0186087 | C980002 | Netherlands | ⤷ Sign Up | 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 | 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 |