FDA Orange Book
Is there a generic for Elucirem?
Elucirem contains gadopiclenol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elucirem (gadopiclenol). The Orange Book shows its last listed patent expires January 17, 2040 and its last listed exclusivity ends February 20, 2029.
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Elucirem products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 1.4553GM/3ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 14.553GM/30ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 24.255GM/50ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 3.63825GM/7.5ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 4.851GM/10ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 48.51GM/100ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 7.2765GM/15ML (485.1MG/ML) | Marketed (Rx) | None | 0 | None |
NDA 216986, held by GUERBET. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Elucirem patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8114863 | May 25, 2032 | Drug substance, Drug product | None | 216986 |
| 10973934 | August 6, 2039 | Drug substance | None | 216986 |
| 12064487 | January 17, 2040 | Method of use | U-4424 | 216986 |
| 11590246 | January 17, 2040 | Drug product | None | 216986 |
Elucirem exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 21, 2027 | 216986 |
| NPP | New patient population | February 20, 2029 | 216986 |
Elucirem NDC codes
Questions
Is there a generic for Elucirem?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Elucirem (gadopiclenol). The Orange Book shows its last listed patent expires January 17, 2040 and its last listed exclusivity ends February 20, 2029.
What is the generic name for Elucirem?
The active ingredient in Elucirem is gadopiclenol, per the FDA Orange Book.
When does the Elucirem patent expire?
The last patent listed for Elucirem in the Orange Book expires January 17, 2040. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.