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Last Updated: December 13, 2019

DrugPatentWatch Database Preview

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. It is available from one supplier. 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-three 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022421
Mechanism of ActionDopamine Agonists
Suppliers and Packaging for NDA: 022421
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0109 0597-0109-07 1 BOTTLE, PLASTIC in 1 CARTON (0597-0109-07) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0109 0597-0109-17 1 BOTTLE, PLASTIC in 1 CARTON (0597-0109-17) > 7 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 022421
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Feb 19, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent 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:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Feb 19, 2010TE:ABRLD:Yes
Patent:  Start TrialPatent 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 022421-004 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-001 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-005 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-003 Feb 19, 2010   Start Trial   Start Trial
Boehringer Ingelheim MIRAPEX ER pramipexole dihydrochloride TABLET, EXTENDED RELEASE;ORAL 022421-002 Feb 19, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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