FDA Orange Book · active-ingredient family
Pramipexole dihydrochloride
Pramipexole dihydrochloride is approved as 2 brand and 30 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MIRAPEX ER · NDA 022421
2
Brand (NDA)
30
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIRAPEX ERRLD×7 | BOEHRINGER INGELHEIM | NDA 022421 | — | Feb 19, 2010 | |
| MIRAPEXRLD×7 | BOEHRINGER INGELHEIM | NDA 020667 | — | Jul 01, 1997 |
Generic (ANDA) products (30)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PRAMIPEXOLE DIHYDROCHLORIDE×7 | NOVAST LABS | ANDA 213444 | AB | Feb 03, 2022 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×2 | XIAMEN LP PHARM CO | ANDA 212797 | AB | Jun 11, 2021 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×7 | ALEMBIC | ANDA 204518 | AB | Jan 02, 2019 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | UNICHEM | ANDA 207011 | — | Dec 19, 2018 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | RISING | ANDA 211088 | AB | Oct 03, 2018 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×7 | ZYDUS PHARMS | ANDA 202891 | AB | Dec 12, 2017 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×2 | ACTAVIS ELIZABETH | ANDA 203615 | AB | Oct 14, 2016 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×7 | MACLEODS PHARMS LTD | ANDA 206156 | AB | Jun 24, 2016 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | ACTAVIS ELIZABETH | ANDA 201963 | AB | Apr 21, 2016 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | DR REDDYS | ANDA 203354 | AB | Aug 07, 2015 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | CHARTWELL RX | ANDA 202353 | AB | Dec 04, 2014 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | SCIEGEN PHARMS | ANDA 203855 | AB | Oct 28, 2014 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | STRIDES PHARMA | ANDA 202702 | AB | Jun 03, 2014 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×7 | PH HEALTH | ANDA 202206 | — | Feb 06, 2014 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | SUN PHARM INDS INC | ANDA 091683 | — | Mar 27, 2013 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | AUROBINDO PHARMA LTD | ANDA 202633 | AB | Oct 26, 2012 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | MACLEODS PHARMS LTD | ANDA 202164 | — | Sep 20, 2012 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | PHARMOBEDIENT | ANDA 090151 | AB | Apr 30, 2012 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | HERITAGE PHARMA AVET | ANDA 091254 | — | Nov 30, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | ALEMBIC | ANDA 078894 | — | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | CHARTWELL RX | ANDA 090241 | — | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | GLENMARK PHARMS LTD | ANDA 090781 | AB | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | HERITAGE PHARMA AVET | ANDA 078551 | — | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | NATCO | ANDA 077854 | — | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | PHARMOBEDIENT | ANDA 091450 | — | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | TORRENT PHARMS | ANDA 090865 | AB | Oct 08, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | SANDOZ | ANDA 090190 | — | Jul 06, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×6 | ZYDUS PHARMS USA INC | ANDA 078920 | AB | Jul 06, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE | NATCO PHARMA | ANDA 090764 | — | Apr 09, 2010 | |
| PRAMIPEXOLE DIHYDROCHLORIDE×5 | HERITAGE PHARMA AVET | ANDA 077724 | — | Feb 19, 2008 |
Listed patents (2)
| 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 |
Pramipexole dihydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
