Question 1

Is there a generic for Trientine tetrahydrochloride?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Trientine tetrahydrochloride. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Trientine tetrahydrochloride?

Accepted Answer

CUVRIOR (NDA 215760, ORPHALAN) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Trientine tetrahydrochloride?

Accepted Answer

The Orange Book lists 4 patents against Trientine tetrahydrochloride products, with the earliest listed expiry in 2039. 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 Trientine tetrahydrochloride have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Trientine tetrahydrochloride. 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 Trientine tetrahydrochloride are approved?

Accepted Answer

Trientine tetrahydrochloride is approved in the following dosage form: tablet.

Patent	Expires	In	Type
12358862	May 03, 2039	in 13 yr 1 mo	SubstanceProductU-4262
12358861	May 03, 2039	in 13 yr 1 mo	SubstanceProductU-4262
11072577	May 03, 2039	in 13 yr 1 mo	U-3370
10988436	May 03, 2039	in 13 yr 1 mo	Substance

Trientine tetrahydrochloride

Brand (NDA) products · tablet

Marketing exclusivity (1)

Listed patents (4)

Trientine tetrahydrochloride — frequently asked questions

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