Question 1

Is there a generic for Eplontersen sodium?

Accepted Answer

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

Question 2

What is the reference-listed drug for Eplontersen sodium?

Accepted Answer

WAINUA (NDA 217388, ASTRAZENECA AB) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Eplontersen sodium?

Accepted Answer

The Orange Book lists 4 patents against Eplontersen sodium products, with the earliest listed expiry in 2026. 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 Eplontersen sodium have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Eplontersen 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 Eplontersen sodium are approved?

Accepted Answer

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

Patent	Expires	In	Type
8101743	Apr 01, 2026	3 mo ago	SubstanceProduct
9127276	May 01, 2034	in 8 yr	Substance
9181549	May 01, 2034	in 8 yr	Substance
10683499	Aug 25, 2034	in 8 yr 4 mo	SubstanceProductU-2378

Eplontersen sodium

Brand (NDA) products · solution

Marketing exclusivity (2)

Listed patents (4)

Eplontersen sodium — frequently asked questions

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