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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 022421

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NDA 022421 describes MIRAPEX ER, which 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. Additional details are available on the MIRAPEX ER profile page.

The generic ingredient in MIRAPEX ER is pramipexole dihydrochloride. There are twenty-five drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for 022421

Tradename:	MIRAPEX ER
Applicant:	Boehringer Ingelheim
Ingredient:	pramipexole dihydrochloride
Patents:	2

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.375MG
Approval Date:	Feb 19, 2010	TE:		RLD:	Yes
Patent:	7,695,734	Patent Expiration:	Apr 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	8,679,533	Patent Expiration:	Sep 8, 2029	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF PARKINSON'S DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	0.75MG
Approval Date:	Feb 19, 2010	TE:		RLD:	Yes
Patent:	7,695,734	Patent Expiration:	Apr 26, 2028	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 022421

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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	022421-004	Feb 19, 2010	4,886,812	⤷ Get Started Free
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-001	Feb 19, 2010	4,886,812	⤷ Get Started Free
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-005	Feb 19, 2010	4,886,812	⤷ Get Started Free
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-003	Feb 19, 2010	4,886,812	⤷ Get Started Free
Boehringer Ingelheim	MIRAPEX ER	pramipexole dihydrochloride	TABLET, EXTENDED RELEASE;ORAL	022421-002	Feb 19, 2010	4,886,812	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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