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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-four drug master file entries for this compound. Thirty-three suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the pramipexole dihydrochloride profile page.

Summary for NDA: 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.375MG
Approval Date:Feb 19, 2010TE:ABRLD:Yes
Patent:7,695,734Patent Expiration:Apr 26, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:8,679,533Patent Expiration:Sep 8, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.75MG
Approval Date:Feb 19, 2010TE:ABRLD:No
Patent:7,695,734Patent Expiration:Apr 26, 2028Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book 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;ORAL022421-004Feb 19, 20104,886,812► subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-001Feb 19, 20104,886,812► subscribe
Boehringer Ingelheim
MIRAPEX ER
pramipexole dihydrochloride
TABLET, EXTENDED RELEASE;ORAL022421-005Feb 19, 20104,886,812► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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