Question 1

Is there a generic for Olezarsen sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Olezarsen sodium?

Accepted Answer

TRYNGOLZA (AUTOINJECTOR) (NDA 218614, IONIS 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 Olezarsen sodium?

Accepted Answer

The Orange Book lists 6 patents against Olezarsen sodium 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 Olezarsen sodium have FDA marketing exclusivity?

Accepted Answer

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

Accepted Answer

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

Patent	Expires	In	Type
9157082	Apr 27, 2032	in 5 yr 11 mo	U-4050
9593333	Feb 14, 2034	in 7 yr 9 mo	U-4050
12509684	May 01, 2034	in 8 yr	U-4050
9181549	May 01, 2034	in 8 yr	Substance
9163239	May 01, 2034	in 8 yr	Substance
9127276	May 01, 2034	in 8 yr	Substance

Olezarsen sodium

Brand (NDA) products · solution

Marketing exclusivity (1)

Listed patents (6)

Olezarsen sodium — frequently asked questions

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