drug
trofinetide
Marketedupdated 3mo agoby $ACAD ACADIA PHARMACEUTICALS INC
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for rett syndrome and 5 investigational indications.
all catalysts(7)
approval · 7
Mar 10, 2023
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Sep 30, 2024
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Sep 30, 2024
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Aug 5, 2025
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Aug 5, 2025
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Dec 11, 2025
approval
$ACAD29.01+2.73%
DAYBUE STIX (TROFINETIDE) — FDA approval
trofinetide
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Mar 27, 2026
approval
$ACAD29.01+2.73%
DAYBUE (TROFINETIDE) — FDA approval
trofinetide
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Trials studying trofinetide
- phase3Open-Label Extension Study of Trofinetide for Rett Syndrome
- phase3An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
- phase3Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
- phase3Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 10, 2028
~1.6 years out
Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.
patents (32)
- Jan 12, 2043patentUS 11827600*PED
- Jan 12, 2043patentUS 11827600*PED
- Jan 12, 2043patentUS 11827600*PED
- Jan 12, 2043patentUS 11827600*PED
- Jan 12, 2043patentUS 12492167*PED
- Jan 12, 2043patentUS 12492167*PED
- Jan 12, 2043patentUS 12492167*PED
- Jan 12, 2043patentUS 12492167*PED
- Jul 12, 2042compositionUS 11827600
- Jul 12, 2042compositionUS 11827600
- Jul 12, 2042compositionUS 11827600
- Jul 12, 2042compositionUS 11827600
- Jul 12, 2042compositionUS 12492167
- Jul 12, 2042compositionUS 12492167
- Jul 12, 2042compositionUS 12492167
- Jul 12, 2042compositionUS 12492167
- Feb 3, 2041patentUS 11370755*PED
- Feb 3, 2041patentUS 11370755*PED
- Feb 3, 2041patentUS 11370755*PED
- Feb 3, 2041patentUS 11370755*PED
- Aug 3, 2040compositionUS 11370755
- Aug 3, 2040compositionUS 11370755
- Aug 3, 2040compositionUS 11370755
- Aug 3, 2040compositionUS 11370755
- Jul 27, 2032patentUS 9212204*PED
- Jul 27, 2032patentUS 9212204*PED
- Jul 27, 2032patentUS 9212204*PED
- Jul 27, 2032patentUS 9212204*PED
- Jan 27, 2032method-of-use (U-3556)US 9212204
- Jan 27, 2032method-of-use (U-3556)US 9212204
- Jan 27, 2032method-of-use (U-3556)US 9212204
- Jan 27, 2032method-of-use (U-3556)US 9212204
FDA exclusivities (16)
- Sep 10, 2030PEDPediatric (6mo bonus)4.1y
- Sep 10, 2030PEDPediatric (6mo bonus)4.1y
- Sep 10, 2030PEDPediatric (6mo bonus)4.1y
- Sep 10, 2030PEDPediatric (6mo bonus)4.1y
- Mar 10, 2030ODE*ODE*3.6y
- Mar 10, 2030ODE-425Orphan Drug (7y)3.6y
- Mar 10, 2030ODE*ODE*3.6y
- Mar 10, 2030ODE*ODE*3.6y
- Sep 10, 2028PEDPediatric (6mo bonus)2.1y
- Sep 10, 2028PEDPediatric (6mo bonus)2.1y
- Sep 10, 2028PEDPediatric (6mo bonus)2.1y
- Sep 10, 2028PEDPediatric (6mo bonus)2.1y
- Mar 10, 2028NCENew Chemical Entity (5y)1.6y
- Mar 10, 2028NCENew Chemical Entity (5y)1.6y
- Mar 10, 2028NCENew Chemical Entity (5y)1.6y
- Mar 10, 2028NCENew Chemical Entity (5y)1.6y
News(1)
- On second try, Acadia drug gets nod from European regulatorsThe influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.biopharma_dive · 1mo ago
Data sources
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