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  1. pharmadog
  2. ›drugs
  3. ›Kisqali
drug · small molecule
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ribociclib succinate

Marketedupdated 5mo 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 4 indications.

targets

Cyclin-dependent kinase 4Cyclin-dependent kinase 6

all catalysts(0)

nothing on the calendar yet

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 17, 2027
348 days

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

patents (12)

  • Apr 14, 2036formulationUS 10799506
  • Apr 14, 2036formulationUS 12064434
  • Apr 14, 2036formulationUS 12419894
  • Aug 7, 2034method-of-use (U-3975)US 12544379
  • Aug 7, 2034method-of-use (U-4405)US 12544380
  • Nov 9, 2031compositionUS 9193732
  • Nov 9, 2031method-of-use (U-3266)US 9868739
  • Mar 13, 2031compositionUS 84153554.4y
  • May 25, 2030compositionUS 86859803.6y
  • Dec 9, 2029method-of-use (U-3975)US 89626303.2y
  • Aug 20, 2029method-of-use (U-3975)US 94161362.9y
  • Jun 17, 2028compositionUS 83242251.7y

FDA exclusivities (1)

  • Sep 17, 2027I-950Indication (3y)348d

News(6)

  • AstraZeneca’s newly approved cancer pill fails late-stage study, blocking path to bigger market
    SERENA-4 was assessing AstraZeneca’s Etcamah as a first-line option for certain patients with advanced breast cancer—a setting that could have meant a $2.9 billion opportunity for the drug.
    biospace · 19d ago
  • Novartis’ board faces investor scrutiny after M&A misfires and R&D flops
    Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.
    biospace · 22d ago
  • AstraZeneca’s SERD pill overcomes adcomm defeat to win FDA nod in breast cancer
    The approval opens up a “modest” market for AstraZeneca’s Etcamah, according to Leerink analysts, who nevertheless looked forward to an upcoming late-stage readout that could lead to a “significant…
    biospace · 25d ago
  • Novartis climbs on upbeat drug sales as key readouts loom
    A return to quarterly sales growth boosted shares higher on Tuesday, though a handful of coming study results will have a bigger impact on the company’s long-term outlook.
    biopharma_dive · 2mo ago
  • Novartis stays 'geography-agnostic' in dealmaking amid flurry of China deals
    Novartis will continue to be on the lookout for bolt-on deals below $2 billion, CEO Vas Narasimhan said Tuesday on the pharma's second quarter earnings call—though major pickups aren’t completely o…
    biospace · 2mo ago
  • Dr McCann on the FDA Approval of Vepdegestrant for ESR1-Mutated, ER+ Advanced Breast Cancer
    Kelly Elizabeth McCann, MD, PhD, notes the role of vepdegestrant in the ESR1-mutated, ER-positive, HER2-negative advanced breast cancer treatment paradigm.
    onclive · 4mo ago
brand
Kisqali
trade names
Kisqali, Ribociclib succinate component of kisqali femara co-pack
generic
ribociclib succinate
MOA
Cyclin-dependent kinase 4 inhibitor; Cyclin-dependent kinase 6 inhibitor
indication
Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer (HER2- Breast Cancer)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 48m ago
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