Question 1

Is there a generic for Seladelpar lysine?

Accepted Answer

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

Question 2

What is the reference-listed drug for Seladelpar lysine?

Accepted Answer

LIVDELZI (NDA 217899, GILEAD SCIENCES 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 Seladelpar lysine?

Accepted Answer

The Orange Book lists 6 patents against Seladelpar lysine 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 Seladelpar lysine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Seladelpar lysine. 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 Seladelpar lysine are approved?

Accepted Answer

Seladelpar lysine is approved in the following dosage form: capsule.

Patent	Expires	In	Type
7301050	Aug 02, 2026	in 1 mo	SubstanceProduct
7709682	Sep 13, 2026	in 3 mo	Substance
11596614	Mar 19, 2035	in 8 yr 11 mo	U-1854
11406611	Mar 19, 2035	in 8 yr 11 mo	U-1854
10272058	Mar 19, 2035	in 8 yr 11 mo	U-1854
9486428	Mar 19, 2035	in 8 yr 11 mo	U-1854

Seladelpar lysine

Brand (NDA) products · capsule

Marketing exclusivity (2)

Listed patents (6)

Seladelpar lysine — frequently asked questions

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