Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

Mar 19, 2035method-of-use (U-1854)US 10272058
Mar 19, 2035method-of-use (U-1854)US 11406611
Mar 19, 2035method-of-use (U-1854)US 11596614
Mar 19, 2035method-of-use (U-1854)US 9486428
Sep 13, 2026compositionUS 770968224d
Aug 2, 2026compositionUS 7301050

FDA exclusivities (2)

Aug 14, 2031ODE-486Orphan Drug (7y)5.0y
Aug 14, 2029NCENew Chemical Entity (5y)3.0y

News(0)

no news has mentioned this drug yet

brand

Livdelzi

generic

seladelpar lysine

MOA

12.1 Mechanism of Action Seladelpar is a peroxisome proliferator-activated receptor (PPAR)-delta (δ) agonist. However, the mechanism by which seladelpar exerts its therapeutic effects in patients with PBC is not well understood. Pharmacological activity that is potentially relevant to therapeutic effects includes inhibition of bile acid synthesis through activation of PPARδ, which is a nuclear receptor expressed in most tissues, including the liver. Published studies show that PPARδ activation by seladelpar reduces bile acid synthesis through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol.

indication

Primary Biliary Cholangitis (Primary Biliary Cirrhosis)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 1h ago

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seladelpar lysine

Marketedupdated 3mo ago

by CymaBay Therapeutics Inc

Approved

community read0 votes

🐶 often sniffed alongside

top 3

Small molecule drug with a maximum clinical stage of Approval, with an approval for biliary liver cirrhosis.

all catalysts(2)

approval · 2

LIVDELZI (SELADELPAR LYSINE) — FDA approval

LIVDELZI (SELADELPAR LYSINE) — FDA approval

seladelpar lysine

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Patent cliff

source: FDA Orange Book

first barrier falls

Sep 13, 2026

24 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (6)

Mar 19, 2035method-of-use (U-1854)US 10272058
Mar 19, 2035method-of-use (U-1854)US 11406611
Mar 19, 2035method-of-use (U-1854)US 11596614
Mar 19, 2035method-of-use (U-1854)US 9486428
Sep 13, 2026compositionUS 770968224d
Aug 2, 2026compositionUS 7301050

FDA exclusivities (2)

Aug 14, 2031ODE-486Orphan Drug (7y)5.0y
Aug 14, 2029NCENew Chemical Entity (5y)3.0y

News(0)

no news has mentioned this drug yet

brand

Livdelzi

generic

seladelpar lysine

MOA

indication

Primary Biliary Cholangitis (Primary Biliary Cirrhosis)

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 1h ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

seladelpar lysine

🐶 often sniffed alongside

all catalysts(2)

Patent cliff

patents (6)

FDA exclusivities (2)

News(0)

Report a data issue

comments(0)

seladelpar lysine

🐶 often sniffed alongside

all catalysts(2)

Patent cliff

patents (6)

FDA exclusivities (2)

News(0)

Report a data issue

comments(0)