MIRAPEX Drug Patent Profile

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 6^th, 2010.

Summary for MIRAPEX

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	246
Clinical Trials:	32
Patent Applications:	2,992
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

See drug prices for MIRAPEX

See drug sales revenues for MIRAPEX

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

See all MIRAPEX clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MIRAPEX

N04BC	Dopamine agonists
N04B	DOPAMINERGIC AGENTS
N04	ANTI-PARKINSON DRUGS
N	Nervous system

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
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-007	Jun 17, 2011	AB	RX	Yes	No			Y
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997		DISCN	Yes	No

Expired US Patents for MIRAPEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-007	Jul 30, 2007
Boehringer Ingelheim	MIRAPEX	pramipexole dihydrochloride	TABLET;ORAL	020667-005	Jul 1, 1997

International Patents for MIRAPEX

See the table below for patents covering MIRAPEX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	5154485
Japan	S63215451	WIPER BLADE
Ireland	853270

Supplementary Protection Certificates for MIRAPEX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186087	C980002	Netherlands		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		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		PRODUCT NAME: PRAMIPEXOL; REGISTRATION NO/DATE: EU/1/97/050/001 19971014