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MIRAPEX Drug Profile
» See Plans and Pricing
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 five Paragraph IV challenges.
The generic ingredient in MIRAPEX is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.
US ANDA 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.
Summary for MIRAPEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 219 |
| Clinical Trials: | 29 |
| Patent Applications: | 4,137 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MIRAPEX |
| DailyMed Link: | MIRAPEX at DailyMed |
Recent Clinical Trials for MIRAPEX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of New Mexico | Early Phase 1 |
| University of New Mexico Clinical and Translational Science Center | Early Phase 1 |
| The Zucker Hillside Hospital | Phase 4 |
Pharmacology for MIRAPEX
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
Paragraph IV (Patent) Challenges for MIRAPEX
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 2008-07-31 |
| MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 2005-06-24 |
| MIRAPEX | TABLET;ORAL | pramipexole dihydrochloride | 020667 | 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 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-007 | Jun 17, 2011 | AB | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | ||
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| >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 | 020667-007 | Jul 30, 2007 | Start Trial | Start Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-006 | Feb 12, 1998 | Start Trial | Start Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MIRAPEX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 168862 | Start Trial |
| European Patent Office | 0186087 | Start Trial |
| Bulgaria | 103543 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MIRAPEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0186087 | SPC/GB98/017 | United Kingdom | Start 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 | 98C0013 | Belgium | Start Trial | PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014 |
| 0186087 | C980002 | Netherlands | Start 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
