Orange Book product · Brand (NDA)

MIRAPEX ER

PRAMIPEXOLE DIHYDROCHLORIDE

Brand (NDA)NDA 022421DISCN BOEHRINGER INGELHEIM

Feb 19, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 19, 2010
16 yr 7 mo ago
Today
Patent 7695734 expires
Listed drug product patent expiration.
Apr 26, 2028
in 1 yr 11 mo
Patent 8679533 expires
Listed drug product patent expiration.
Sep 08, 2029
in 3 yr 3 mo

Active ingredient

PRAMIPEXOLE DIHYDROCHLORIDE

Strength

0.375MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 022421

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7695734	Apr 26, 2028	in 1 yr 11 mo	Product
8679533	Sep 08, 2029	in 3 yr 3 mo	ProductU-219