FDA Orange Book · active-ingredient family
Gadopiclenol
Gadopiclenol is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ELUCIREM · NDA 216986
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
14
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ELUCIREMRLD×7 | GUERBET | NDA 216986 | — | Sep 21, 2022 |
Marketing exclusivity (14)
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
- NCENew chemical entity exclusivity (5 years)
Sep 21, 2027
in 1 yr 3 mo
- NPPNew patient population exclusivity (3 years)
Feb 20, 2029
in 2 yr 9 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8114863 | Sep 19, 2028 | in 2 yr 3 mo | Substance |
| 10973934 | Aug 06, 2039 | in 13 yr 4 mo | Substance |
| 12064487 | Jan 17, 2040 | in 13 yr 9 mo | U-4424 |
| 11590246 | Jan 17, 2040 | in 13 yr 9 mo | Product |
Gadopiclenol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
