FDA Orange Book
Generic for Lutathera
Lutathera contains lutetium lu-177 dotatate. 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
Yes. The generic name for Lutathera is lutetium lu-177 dotatate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Lutathera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 10mCi/ML | Marketed (Rx) | AP | 1 | AP |
NDA 208700, held by ADVANCED ACCELERATOR APPLICATIONS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lutetium lu-177 dotatate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| LANTHEUS MEDICAL IMAGING INC | 217060 | AP (A-rated, therapeutically equivalent) | September 21, 2026 | 10mCi/ML |
Lutathera patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12168063 | July 25, 2038 | Drug product | U-4036 | 208700 |
| 12415003 | July 25, 2038 | Method of use | U-4036 | 208700 |
| 12491272 | July 25, 2038 | Method of use | U-4036 | 208700 |
| 12144873 | July 25, 2038 | Method of use | U-4036 | 208700 |
| 12151003 | July 25, 2038 | Drug product | U-4036 | 208700 |
| 12161732 | July 25, 2038 | Drug product | U-4036 | 208700 |
| 10596278 | July 25, 2038 | Drug product | None | 208700 |
| 10596276 | July 25, 2038 | Drug product | None | 208700 |
| 11904027 | July 25, 2038 | Drug product | None | 208700 |
| 12415003*PED | January 25, 2039 | Method of use | None | 208700 |
| 12144873*PED | January 25, 2039 | Method of use | None | 208700 |
| 12151003*PED | January 25, 2039 | Method of use | None | 208700 |
| 12491272*PED | January 25, 2039 | Method of use | None | 208700 |
| 10596278*PED | January 25, 2039 | Method of use | None | 208700 |
| 10596276*PED | January 25, 2039 | Method of use | None | 208700 |
| 12161732*PED | January 25, 2039 | Method of use | None | 208700 |
| 11904027*PED | January 25, 2039 | Method of use | None | 208700 |
| 12168063*PED | January 25, 2039 | Method of use | None | 208700 |
Lutathera exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | April 23, 2027 | 208700 |
| PED | Pediatric exclusivity | October 23, 2027 | 208700 |
| ODE-479 | Orphan drug exclusivity | April 23, 2031 | 208700 |
| PED | Pediatric exclusivity | October 23, 2031 | 208700 |
Lutathera NDC codes
Questions
Is there a generic for Lutathera?
Yes. The generic name for Lutathera is lutetium lu-177 dotatate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Lutathera?
The active ingredient in Lutathera is lutetium lu-177 dotatate, per the FDA Orange Book.
When does the Lutathera patent expire?
The last patent listed for Lutathera in the Orange Book expires January 25, 2039. 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.