FDA Orange Book

Is there a generic for Detectnet?

Detectnet contains copper cu-64 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

No. The Orange Book lists no active FDA-approved generic (ANDA) for Detectnet (copper cu-64 dotatate). The Orange Book shows its last listed patent expires September 3, 2041 and its last listed exclusivity ends September 3, 2027.

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Detectnet products in the Orange Book

Detectnet products and approved generics
Form and routeStrengthBrand statusBrand TEActive genericsGeneric TE codes
solution, intravenous4mL (1mCi/ML)Marketed (Rx)None0None

NDA 213227, held by CURIUM US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Detectnet patents

Patents listed for Detectnet
PatentExpiresCoversUse codeNDA
10159759August 23, 2032Method of useU-2951213227
11160888August 23, 2032Method of useU-2951213227
10383961July 2, 2033Method of useU-2951213227
12102696September 3, 2041Drug productNone213227

Detectnet exclusivity

Exclusivity listed for Detectnet
CodeMeaningExpiresNDA
ODE-317Orphan drug exclusivitySeptember 3, 2027213227

Detectnet NDC codes

Questions

Is there a generic for Detectnet?

No. The Orange Book lists no active FDA-approved generic (ANDA) for Detectnet (copper cu-64 dotatate). The Orange Book shows its last listed patent expires September 3, 2041 and its last listed exclusivity ends September 3, 2027.

What is the generic name for Detectnet?

The active ingredient in Detectnet is copper cu-64 dotatate, per the FDA Orange Book.

When does the Detectnet patent expire?

The last patent listed for Detectnet in the Orange Book expires September 3, 2041. 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.

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