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PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details
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What are the generic sources for pramipexole dihydrochloride and what is the scope of patent protection?
Pramipexole dihydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Actavis Elizabeth, Alembic Pharms Ltd, Anchen Pharms, Dr Reddys, Macleods Pharms Ltd, Sandoz Inc, Zydus Pharms, Aurobindo Pharma Ltd, Breckenridge Pharm, Glenmark Generics, Graviti Pharms, Heritage Pharma, Mylan, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem Labs Ltd, Zennova, and Zydus Pharms Usa Inc, and is included in thirty NDAs. There are two patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Pramipexole dihydrochloride has two hundred and thirty-two patent family members in forty-four countries.
There are twenty-five drug master file entries for pramipexole dihydrochloride. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for PRAMIPEXOLE DIHYDROCHLORIDE
| International Patents: | 232 |
| US Patents: | 2 |
| Tradenames: | 3 |
| Applicants: | 22 |
| NDAs: | 30 |
| Drug Master File Entries: | 25 |
| Suppliers / Packagers: | 23 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 114 |
| Patent Applications: | 2,235 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for PRAMIPEXOLE DIHYDROCHLORIDE |
| DailyMed Link: | PRAMIPEXOLE DIHYDROCHLORIDE at DailyMed |
Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hongguan biological pharmaceutical co. | N/A |
| First Affiliated Hospital of Zhejiang University | N/A |
| Vanderbilt University Medical Center | Phase 1 |
Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 4.5MG | TABLET, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 3MG | TABLET, EXTENDED RELEASE;ORAL |
| Start Trial | Start Trial | 1.5MG | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for PRAMIPEXOLE DIHYDROCHLORIDE
| Drug Class | Nonergot Dopamine Agonist |
| Mechanism of Action | Dopamine Agonists |
Paragraph IV (Patent) Challenges for PRAMIPEXOLE DIHYDROCHLORIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| MIRAPEX ER | TABLET, EXTENDED RELEASE;ORAL | pramipexole dihydrochloride | 022421 | 2011-07-26 |
| MIRAPEX ER | TABLET, EXTENDED RELEASE;ORAL | pramipexole dihydrochloride | 022421 | 2010-06-01 |
| 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 PRAMIPEXOLE DIHYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Zydus Pharms | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 202891-004 | Dec 12, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Dr Reddys | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 203354-003 | Aug 7, 2015 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Actavis Elizabeth | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET, EXTENDED RELEASE;ORAL | 201963-002 | Apr 21, 2016 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Breckenridge Pharm | PRAMIPEXOLE DIHYDROCHLORIDE | pramipexole dihydrochloride | TABLET;ORAL | 091450-002 | Oct 8, 2010 | AB | RX | No | 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 PRAMIPEXOLE DIHYDROCHLORIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | Start Trial | Start Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-001 | Jul 1, 1997 | Start Trial | Start Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-005 | Jul 1, 1997 | Start Trial | Start Trial |
| Boehringer Ingelheim | MIRAPEX | pramipexole dihydrochloride | TABLET;ORAL | 020667-006 | Feb 12, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PRAMIPEXOLE DIHYDROCHLORIDE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | 200412962 | Start Trial |
| European Patent Office | 1781260 | Start Trial |
| Norway | 20070719 | Start Trial |
| Eurasian Patent Organization | 200700201 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE
| 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 |
| >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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