MIRAPEX Drug Patent Profile
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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-five 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.
Summary for MIRAPEX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 279 |
| Clinical Trials: | 32 |
| Patent Applications: | 4,739 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for MIRAPEX
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-007 | Jun 17, 2011 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-003 | Feb 19, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 | 020667-004 | Jul 1, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| Spain | 2231959 | ⤷ Try a Trial | |
| Australia | 6016898 | ⤷ Try a Trial | |
| Spain | 8707515 | ⤷ Try a Trial | |
| South Korea | 100761774 | ⤷ Try a Trial | |
| Poland | 190898 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MIRAPEX
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 | 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 | 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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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