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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
351 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)351d

News(6)

  • Vera’s newly approved IgA nephropathy drug supports kidney function, like Otsuka’s Voyxact
    Otsuka Pharmaceuticals’ Voyxact is not the only IgA nephropathy drug that can slow the decline of kidney function. Vera Therapeutics’ Trutakna, which the FDA granted accelerated approval last month…
    biospace · 3d ago
  • 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 · 16d 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 · 1mo 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 · 1mo 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 · 1mo 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 · 1mo 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 23m ago
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