Question 1

Is there a generic for Givosiran sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Givosiran sodium?

Accepted Answer

GIVLAARI (NDA 212194, ALNYLAM PHARMS INC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Givosiran sodium?

Accepted Answer

The Orange Book lists 8 patents against Givosiran sodium products, with the earliest listed expiry in 2028. 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 Givosiran sodium have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
10131907	Aug 24, 2028	in 2 yr 3 mo	SubstanceProductU-2672
8828956	Dec 04, 2028	in 2 yr 6 mo	SubstanceProductU-2672
8106022	Dec 12, 2029	in 3 yr 6 mo	SubstanceProductU-2672
9631193	Mar 15, 2033	in 6 yr 10 mo	U-2672
10125364	Mar 15, 2033	in 6 yr 10 mo	SubstanceProductU-2672
9133461	Nov 30, 2033	in 7 yr 7 mo	SubstanceProductU-2672
10119143	Oct 03, 2034	in 8 yr 5 mo	SubstanceProductU-2672
11028392	Oct 03, 2034	in 8 yr 5 mo	SubstanceProductU-2672

Givosiran sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (8)

Givosiran sodium — frequently asked questions

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