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  1. pharmadog
  2. ›drugs
  3. ›Fabhalta
drug · small molecule
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iptacopan hydrochloride

Marketedupdated 3mo ago
by $NVS NOVARTIS AG🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for paroxysmal nocturnal hemoglobinuria and iga glomerulonephritis and 2 investigational indications.

targets

Complement factor B

all catalysts(0)

nothing on the calendar yet

Patent cliff

source: FDA Orange Book
first barrier falls
Aug 7, 2027
357 days

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

patents (8)

  • Jul 15, 2041method-of-use (U-3895)US 11951101
  • Jul 15, 2041method-of-use (U-4300)US 12453726
  • May 25, 2041compositionUS 11603363
  • May 17, 2041method-of-use (U-4161)US 12384758
  • Aug 30, 2038method-of-use (U-3980)US 11723901
  • Aug 30, 2038method-of-use (U-4181)US 12285422
  • Jul 14, 2034method-of-use (U-3980)US 10093663
  • Jul 14, 2034compositionUS 9682968

FDA exclusivities (4)

  • Dec 5, 2030ODE-456Orphan Drug (7y)4.3y
  • Dec 5, 2028NCENew Chemical Entity (5y)2.3y
  • Mar 20, 2028I-963Indication (3y)1.6y
  • Aug 7, 2027I-949Indication (3y)357d

News(5)

  • Vertex unfazed by competitive IgAN space as FDA verdict looms
    Positive two-year follow-up data for Otsuka Pharmaceuticals’ IgA nephropathy drug Voyxact could support the FDA’s ongoing review of Vertex Pharmaceuticals’ povetacicept, CEO Reshma Kewalramani said…
    biospace · 10d ago
  • Bristol Myers to build ‘powerful’ AI factory; Samsung Biologics bids for peptide maker
    Bristol Myers is the third pharmaceutical company to recently seek Nvidia’s help building a large AI data center. Elsewhere, a Novartis kidney drug gained a leg up on competitors.
    biopharma_dive · 25d ago
  • Vertex’s IgA nephropathy drug derisked after Novartis, Vera approvals
    The FDA is currently reviewing Vertex Pharmaceuticals’ povetacicept, with a target action date of Nov. 30. If approved, the drug could benefit from campaigns from Novartis and Vera Therapeutics for…
    biospace · 25d ago
  • Jasper gets a lifeline in merger with immune drugmaker Kira
    The acquisition, which involves a concurrent licensing deal with startup Mirador, gives Jasper a chance to rebound from setbacks that have wiped out most of its market value.
    biopharma_dive · 28d ago
  • Jasper finds new purpose in merger with Kira, while offloading Tavneos rival to Mirador
    Jasper Therapeutics is being reborn via a merger with Nasdaq-listed immune-mediated disease biotech Kira Pharmaceuticals.
    fiercebiotech · 28d ago
brand
Fabhalta
trade names
Fabhalta
generic
iptacopan hydrochloride
MOA
Complement factor B inhibitor
indication
Myasthenia Gravis
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 37m ago
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