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  3. ›Ekterly
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sebetralstat

Marketedupdated 3mo ago
by $KALV KalVista Pharmaceuticals, Inc.
Approved
community read0 votes

all catalysts(0)

nothing on the calendar yet

Trials studying sebetralstat

  • —Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With Sebetralstatavailable
  • —Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstatapproved for marketing

Patent cliff

source: FDA Orange Book
first barrier falls
Jul 3, 2030
~3.9 years out

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

patents (8)

  • Jan 26, 2039formulationUS 11234939
  • Dec 25, 2037compositionUS 11230537
  • Jun 23, 2037method-of-use (U-4223)US 11739068
  • Nov 26, 2035compositionUS 10364238
  • Nov 26, 2035method-of-use (U-4223)US 10611758
  • Nov 26, 2035compositionUS 11001578
  • Nov 26, 2035compositionUS 11084809
  • Nov 26, 2035method-of-use (U-4223)US 11198691

FDA exclusivities (1)

  • Jul 3, 2030NCENew Chemical Entity (5y)3.9y

News(4)

  • ‘We’re not afraid of competition’: BioCryst CEO sets out strategy after scrapping internal discovery
    BioCryst CEO Charlie Gayer told Fierce the company is “not getting away from science and R&D” despite shutting down its internal discovery efforts.
    fiercebiotech · 6d ago
  • Gossamer regains rights to lung disease asset from Chiesi after Phase 3 fail
    Despite a Phase 3 miss, Gossamer Bio is full steam ahead for its lung disease asset, pointing to previous “review issues” at the FDA as one of the reasons to continue development.
    biospace · 24d ago
  • Chiesi to buy KalVista in $1.9B deal for rare disease drug
    The acquisition is the fifth of a biotech company so far this week and, according to some Wall Street analysts, proves pharma’s interest in new and emerging oral therapies for hereditary angioedema.
    biopharma_dive · 3mo ago
  • STAT+: A patent win for Pfizer and BridgeBio
    A change to FDA clinical trial data review, Rocket sells its priority review voucher, and more biotech news from The Readout
    stat · 3mo ago
brand
Ekterly
generic
sebetralstat [INN]
indication
Hereditary Angioedema (HAE) (C1 Esterase Inhibitor [C1-INH] Deficiency)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 38m ago
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