Question 1

Is there a generic for Copper cu-64 dotatate?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Copper cu-64 dotatate. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Copper cu-64 dotatate?

Accepted Answer

DETECTNET (NDA 213227, CURIUM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Copper cu-64 dotatate?

Accepted Answer

The Orange Book lists 4 patents against Copper cu-64 dotatate products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Copper cu-64 dotatate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Copper cu-64 dotatate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Copper cu-64 dotatate are approved?

Accepted Answer

Copper cu-64 dotatate is approved in the following dosage form: solution.

Patent	Expires	In	Type
10159759	Aug 23, 2032	in 6 yr 3 mo	U-2951
11160888	Aug 23, 2032	in 6 yr 3 mo	U-2951
10383961	Jul 02, 2033	in 7 yr 2 mo	U-2951
12102696	Sep 03, 2041	in 15 yr 5 mo	Product

Copper cu-64 dotatate

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (4)

Copper cu-64 dotatate — frequently asked questions

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