FDA Orange Book · active-ingredient family
Droxidopa
Droxidopa is approved as 1 brand and 16 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORTHERA · NDA 203202
1
Brand (NDA)
16
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORTHERARLD×3 | LUNDBECK NA LTD | NDA 203202 | AB | Feb 18, 2014 |
Generic (ANDA) products (16)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DROXIDOPA×3 | CHARTWELL RX | ANDA 214217 | — | May 05, 2022 | |
| DROXIDOPA×3 | ADAPTIS | ANDA 215265 | AB | Nov 01, 2021 | |
| DROXIDOPA×3 | ANNORA | ANDA 211726 | AB | Aug 09, 2021 | |
| DROXIDOPA×3 | SOMERSET THERAPS LLC | ANDA 214543 | AB | May 05, 2021 | |
| DROXIDOPA×3 | BIONPHARMA | ANDA 213033 | AB | Apr 28, 2021 | |
| DROXIDOPA×3 | ALKEM LABS LTD | ANDA 213911 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | AUROBINDO PHARMA LTD | ANDA 214387 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | HIKMA | ANDA 212835 | — | Feb 18, 2021 | |
| DROXIDOPA×3 | JUBILANT CADISTA | ANDA 214391 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | LUPIN PHARMS | ANDA 211652 | — | Feb 18, 2021 | |
| DROXIDOPA×3 | MSN PHARMS INC | ANDA 211741 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | SCIEGEN PHARMS | ANDA 214017 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | SUN PHARM | ANDA 214384 | AB | Feb 18, 2021 | |
| DROXIDOPA×3 | TEVA PHARMS USA INC | ANDA 213162 | — | Feb 18, 2021 | |
| DROXIDOPA×3 | UPSHER SMITH LABS | ANDA 213661 | — | Feb 18, 2021 | |
| DROXIDOPA×3 | ZYDUS PHARMS | ANDA 211818 | AB | Feb 18, 2021 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Droxidopa — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
