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Last Updated: October 12, 2024

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-four 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:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Feb 19, 2010TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Sep 8, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Feb 19, 2010TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Apr 26, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022421

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 022421-002 Feb 19, 2010 ⤷  Sign Up ⤷  Sign Up
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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