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.
The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There is one drug master file entry for this compound. Twenty-two 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.
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Questions you can ask:
- What is the 5 year forecast for MIRAPEX ER?
- What are the global sales for MIRAPEX ER?
- What is Average Wholesale Price for MIRAPEX ER?
Summary for MIRAPEX ER
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 32 |
| Patent Applications: | 1,807 |
| Drug Prices: | Drug price information for MIRAPEX ER |
| DailyMed Link: | MIRAPEX ER at DailyMed |
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 |
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.
| 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 ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-001 | Feb 19, 2010 | DISCN | Yes | No | 8,679,533 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-006 | Jun 17, 2011 | DISCN | Yes | No | 8,679,533 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-002 | Feb 19, 2010 | DISCN | Yes | No | 7,695,734 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-007 | Jun 17, 2011 | DISCN | Yes | No | 7,695,734 | ⤷ Start Trial | Y | ⤷ 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 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 | 4,886,812 | ⤷ Start Trial |
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-005 | Feb 19, 2010 | 4,886,812 | ⤷ Start Trial |
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-004 | Feb 19, 2010 | 4,886,812 | ⤷ Start Trial |
| Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-002 | Feb 19, 2010 | 4,886,812 | ⤷ Start 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 |
|---|---|---|---|
| Austria | 45735 | ⤷ Start Trial | |
| Australia | 5154485 | ⤷ Start Trial | |
| Australia | 583874 | ⤷ Start Trial | |
| Bulgaria | 62023 | ⤷ Start 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 | ⤷ 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 | 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 |
| 0186087 | 98C0013 | Belgium | ⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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