Question 1

Is there a generic for Plozasiran sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Plozasiran sodium?

Accepted Answer

REDEMPLO (NDA 219947, ARROWHEAD) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Plozasiran sodium?

Accepted Answer

The Orange Book lists 5 patents against Plozasiran sodium 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 Plozasiran sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Plozasiran sodium. 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 Plozasiran sodium are approved?

Accepted Answer

Plozasiran sodium is approved in the following dosage form: solution.

Patent	Expires	In	Type
10294474	Mar 07, 2037	in 10 yr 10 mo	SubstanceProductU-4360
11174481	Mar 07, 2037	in 10 yr 10 mo	SubstanceProduct
12365899	Sep 10, 2038	in 12 yr 5 mo	SubstanceProductU-4360
11214801	Sep 10, 2038	in 12 yr 5 mo	SubstanceProductU-4360
10597657	Sep 10, 2038	in 12 yr 5 mo	SubstanceProductU-4360

Plozasiran sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (5)

Plozasiran sodium — frequently asked questions

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