FDA Orange Book · active-ingredient family
Citric acid; magnesium oxide; sodium picosulfate
Citric acid; magnesium oxide; sodium picosulfate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CLENPIQ · NDA 209589
2
Brand (NDA)
1
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLENPIQRLD | FERRING PHARMS INC | NDA 209589 | — | Nov 28, 2017 | |
| PREPOPIKRLD | FERRING PHARMS INC | NDA 202535 | — | Jul 16, 2012 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID | HETERO LABS LTD V | ANDA 212789 | — | Jul 18, 2022 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8450338 | Oct 10, 2028 | in 2 yr 4 mo | Product |
| 8481083 | Oct 10, 2028 | in 2 yr 4 mo | Product |
| 11191753 | Jun 23, 2034 | in 8 yr 2 mo | U-3261 |
| 12576072 | Jun 23, 2034 | in 8 yr 2 mo | ProductU-3261 |
| 10624879 | Jun 23, 2034 | in 8 yr 2 mo | Product |
| 9827231 | Jun 26, 2034 | in 8 yr 2 mo | ProductU-2162 |
| 12458634 | Jan 27, 2038 | in 11 yr 9 mo | Product |
Citric acid; magnesium oxide; sodium picosulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
