Question 1

Is there a generic for Terlipressin acetate?

Accepted Answer

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

Question 2

What is the reference-listed drug for Terlipressin acetate?

Accepted Answer

TERLIVAZ (NDA 022231, MALLINCKRODT IRELAND) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Terlipressin acetate?

Accepted Answer

The Orange Book lists 1 patent against Terlipressin acetate products, with the earliest listed expiry in 2037. 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 Terlipressin acetate have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Terlipressin acetate. 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 Terlipressin acetate are approved?

Accepted Answer

Terlipressin acetate is approved in the following dosage form: powder.

Terlipressin acetate

Brand (NDA) products · powder

Marketing exclusivity (2)

Listed patents (1)

Terlipressin acetate — frequently asked questions

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