➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Boehringer Ingelheim
McKesson
Colorcon
Express Scripts

Last Updated: August 3, 2021

DrugPatentWatch Database Preview

PRAMIPEXOLE DIHYDROCHLORIDE - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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, Glenmark Generics, Heritage Pharma, Mylan, Nostrum Labs Inc, Rising, Sandoz, Sciegen Pharms Inc, Strides Pharma, Sun Pharm Inds Inc, Torrent Pharms, Unichem, 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-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for PRAMIPEXOLE DIHYDROCHLORIDE
Drug Prices for PRAMIPEXOLE DIHYDROCHLORIDE

See drug prices for PRAMIPEXOLE DIHYDROCHLORIDE

Recent Clinical Trials for PRAMIPEXOLE DIHYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Massachusetts General HospitalPhase 2/Phase 3
First Affiliated Hospital of Zhejiang UniversityN/A
Hongguan biological pharmaceutical co.N/A

See all PRAMIPEXOLE DIHYDROCHLORIDE clinical trials

Generic filers with tentative approvals for PRAMIPEXOLE DIHYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free4.5MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free3MGTABLET, EXTENDED RELEASE;ORAL
⤷  Try it Free⤷  Try it Free1.5MGTABLET, 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 ClassNonergot Dopamine Agonist
Mechanism of ActionDopamine 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
Sandoz PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090190-006 Oct 8, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Anchen Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202206-003 Feb 6, 2014 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alembic Pharms Ltd PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 204518-005 Jan 2, 2019 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Glenmark Generics PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090781-004 Oct 8, 2010 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm Inds Inc PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 091683-001 Mar 27, 2013 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Zydus Pharms PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 202891-003 Dec 12, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Heritage Pharma PRAMIPEXOLE DIHYDROCHLORIDE pramipexole dihydrochloride TABLET;ORAL 090241-005 Oct 8, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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

Supplementary Protection Certificates for PRAMIPEXOLE DIHYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0186087 SPC/GB98/017 United Kingdom ⤷  Try it Free 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Merck
Johnson and Johnson
Boehringer Ingelheim
McKesson
Colorcon
Express Scripts

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.