pramipexole dihydrochloride · Boehringer Ingelheim · NDA 022421
Mirapex Er
Earliest generic entry, as listed · earliest of 7 marketed strengths
8 Sep 2029
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8679533.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8679533 | drug product, use U-219 · sets the listed date | 8 Sep 2029 |
| US 7695734 | drug product | 26 Apr 2028 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022421 · 001 · RLD · discontinued | tablet, extended release, oral | 0.375MG | 8 Sep 2029 |
| 022421 · 002 · RLD · discontinued | tablet, extended release, oral | 0.75MG | 8 Sep 2029 |
| 022421 · 003 · RLD · discontinued | tablet, extended release, oral | 1.5MG | 8 Sep 2029 |
| 022421 · 004 · RLD · discontinued | tablet, extended release, oral | 3MG | 8 Sep 2029 |
| 022421 · 005 · RLD · discontinued | tablet, extended release, oral | 4.5MG | 8 Sep 2029 |
| 022421 · 006 · RLD · discontinued | tablet, extended release, oral | 2.25MG | 8 Sep 2029 |
| 022421 · 007 · RLD · discontinued | tablet, extended release, oral | 3.75MG | 8 Sep 2029 |