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.

This drug has two hundred and thirty-one patent family members in forty-four countries.

The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-four 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 6^th, 2010.

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Summary for MIRAPEX ER

International Patents:	231
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	32
Patent Applications:	1,958
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for MIRAPEX ER
DailyMed Link:	MIRAPEX ER at DailyMed

Drug patent expirations by year for MIRAPEX ER

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	Early Phase 1
University of New Mexico Clinical and Translational Science Center	Early Phase 1

See all MIRAPEX ER clinical trials

Pharmacology for MIRAPEX ER

Drug Class	Nonergot Dopamine Agonist
Mechanism of Action	Dopamine Agonists

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.

Patents protecting MIRAPEX ER

Extended release tablet formulation containing pramipexole or a pharmaceutically acceptable salt thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Pramipexole once-daily dosage form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PARKINSON'S DISEASE

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Glossary

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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	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-006	Jun 17, 2011	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010	⤷ Sign Up	⤷ Sign Up
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-004	Feb 19, 2010	⤷ Sign Up	⤷ Sign Up
>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.

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Country	Patent Number	Title	Estimated Expiration
South Korea	101406767		⤷ Sign Up
Argentina	050602	FORMULACION EN COMPRIMIDOS DE LIBERACION EXTENDIDA QUE CONTIENE PRAMIPEXOL O SU SAL FARMACEUTICAMENTE ACEPTABLE, UN METODO PARA SU FABRICACION Y SU USO.	⤷ Sign Up
Malaysia	136318	SUSTAINED-RELEASE TABLET COMPOSITION	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MIRAPEX ER

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