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Generated: July 22, 2017
What is the patent landscape for Mirapex, and when can generic versions of Mirapex launch?
Mirapex is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are four patents protecting this drug and five Paragraph IV challenges.| Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: see list | 5 |
| Bulk Api Vendors: see list | 131 |
| Clinical Trials: see list | 28 |
| Patent Applications: see list | 4,127 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | MIRAPEX at DailyMed |
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
| 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 | 6,194,445 | ► Subscribe | ► Subscribe | |||||||||||||||||
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-003 | Feb 19, 2010 | AB | RX | Yes | No | 7,695,734 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Boehringer Ingelheim | MIRAPEX ER | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022421-007 | Jun 17, 2011 | AB | RX | Yes | No | 7,695,734 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-007 | Jul 30, 2007 | AB | RX | Yes | No | 6,194,445 | ► Subscribe | ► Subscribe | |||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | AB | RX | Yes | Yes | 6,001,861 | ► Subscribe | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-004 | Jul 1, 1997 | 4,886,812 | ► Subscribe | ||||||||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | 4,843,086 | ► Subscribe | ||||||||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | 4,886,812 | ► Subscribe | ||||||||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-002 | Jul 1, 1997 | 4,886,812 | ► Subscribe | ||||||||||||||||||||||
Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-004 | Jul 1, 1997 | 4,843,086 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| pramipexole dihydrochloride | Extended-release Tablets | 2.25 mg and 3.75 mg | Mirapex ER | 7/26/2011 |
| pramipexole dihydrochloride | Extended-release Tablets | 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg | Mirapex ER | 6/1/2010 |
| pramipexole dihydrochloride | Tablets | 0.75 mg | Mirapex | 7/31/2008 |
| pramipexole dihydrochloride | Tablets | 0.125 mg, 0.5 mg, 1 mg and 1.5 mg | Mirapex | 6/24/2005 |
| pramipexole dihydrochloride | Tablets | 0.25 mg | Mirapex | 5/27/2005 |
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Germany | 69827387 | ► Subscribe | |||||||||||||||||||||||||||
| South Africa | 9800420 | ► Subscribe | |||||||||||||||||||||||||||
| Slovenia | 989850 | ► Subscribe | |||||||||||||||||||||||||||
| Norway | 993360 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20000070234 | ► Subscribe | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C/GB98/017 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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 verifification 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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