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  1. pharmadog
  2. ›drugs
  3. ›Tagrisso
drug · small molecule
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osimertinib mesylate

Marketedupdated 5mo ago
by $AZN ASTRAZENECA PLC🔗 ChEMBL
Approved
annual revenue · 2024–2024peak $6.6B
2024: $6.6B2024$6.6B
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for non-small cell lung carcinoma and 1 investigational indication.

indications

investigational
NSCLC

targets

Epidermal growth factor receptor

all catalysts(0)

nothing on the calendar yet

Trials studying osimertinib mesylate

  • phase1Study of ONO-7475 in Combination With Osimertinib in EGFR Gene Mutation-positive Non-small Cell Lung Cancercompletedn=78
  • phase3A Study Evaluating Furmonertinib Plus Platinum-based Doublet Chemotherapy Versus Osimertinib in Patients With Epidermal Growth Factor Receptor (EGFR) Sensitizing Mutation-Positive Non-squamous Non-Small Cell Lung Cancer (NSCLC) and Brain Metastasesrecruitingn=380
  • phase2A Study of SHR-A2102 in Combination With Other Anti-tumor Therapies for Resectable Non-small Cell Lung Cancerrecruitingn=300
  • phase2A Study to Evaluate Safety and Efficacy of WSD0922-FU Combo With Osimertinib for NSCLCrecruitingn=48
  • phase1A Study of APG-1252 Plus Osimertinib(AZD9291) in EGFR TKI Resistant NSCLC Patientsactive not recruitingn=80
  • phase2A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Canceractive not recruitingn=198
  • phase2A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancerrecruitingn=40
  • phase2A Trial of SHR-A2102 With Other Antitumor Therapies in Advanced Solid Tumorsrecruitingn=400

Patent cliff

source: FDA Orange Book
first barrier falls
Feb 16, 2027
134 days

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

patents (10)

  • Nov 26, 2042method-of-use (U-3823)US 12465608
  • Nov 26, 2042method-of-use (U-3823)US 12465608
  • Jan 2, 2035formulationUS 10183020
  • Jan 2, 2035formulationUS 10183020
  • Aug 8, 2032compositionUS 8946235
  • Aug 8, 2032compositionUS 8946235
  • Jul 25, 2032compositionUS 11524951
  • Jul 25, 2032compositionUS 11524951
  • Jul 25, 2032compositionUS 9732058
  • Jul 25, 2032compositionUS 9732058

FDA exclusivities (6)

  • Dec 18, 2027ODE-337Orphan Drug (7y)1.2y
  • Dec 18, 2027ODE-337Orphan Drug (7y)1.2y
  • Sep 25, 2027I-952Indication (3y)355d
  • Sep 25, 2027I-952Indication (3y)355d
  • Feb 16, 2027I-941Indication (3y)134d
  • Feb 16, 2027I-941Indication (3y)134d

News(10)

  • Rare EGFR mutation increases lung cancer risk 62 times in never smokers
    A rare inherited germline mutation was found to increase risk for lung cancer by 25 times, while smoking only increased risk by 4 times.
    fiercebiotech · 17d ago
  • WCLC ‘26: A new ‘ADC era,’ China questions and AstraZeneca’s spotlight
    The year’s biggest meeting on lung cancer research featured data suggesting a new treatment standard for an aggressive tumor as well as debate about the reliability of results from China-run studies.
    biopharma_dive · 19d ago
  • Cullinan, Taiho showcase 6-month survival benefit in phase 3 trial for advanced lung cancer
    Cullinan Therapeutics and Taiho Oncology unveiled phase 3 data showing survival improvements greater than Johnson & Johnson’s Rybrevant in patients with advanced non-small cell lung cancer in the f…
    fiercebiotech · 23d ago
  • GSK pens $1.3B Hutchmed deal for early-stage KRAS-EGFR cancer asset
    GSK is handing over $110 million upfront to Hutchmed in a deal worth up to $1.295 billion to get its hands on a first-in-class oncology candidate.
    fiercebiotech · 1mo ago
  • AstraZeneca scores in lung cancer; Sandoz inks a China deal
    A combination of AstraZeneca’s Tagrisso and Hutchmed’s Orpathys extended survival for some lung cancer patients. Elsewhere, MapLight floated the idea of partnering on its autism drug.
    biopharma_dive · 1mo ago
  • AstraZeneca touts separate late-stage lung cancer wins with Tagrisso, Enhertu
    AstraZeneca on Monday reported successes in two late-stage trials in different forms of lung cancer — one with a two-drug combination of Tagrisso and Orpathys and another with its blockbuster antib…
    endpoints · 1mo ago
  • New Taiho, Cullinan data heats up lung cancer drug battle
    The findings position their drug, zipalertinib, as a threat to multiple approved medicines — while setting a bar for others in testing.
    biopharma_dive · 1mo ago
  • BlossomHill, Latigo outshine IPO expectations with oversubscribed debuts
    Two growing biotechs blasted through their IPO expectations Friday, with Blossom Hill Therapeutics and Latigo Biotherapeutics each raising at least 30% more than expected in their stock market debuts.
    fiercebiotech · 1mo ago
  • Latigo laces up for $247M IPO to fund non-opioid pain drug rival to Vertex’s Journavx
    Latigo Biotherapeutics has fleshed out its plans for an IPO to finance the development of its clinical-stage pipeline of non-opioid pain management drugs.
    fiercebiotech · 2mo ago
  • ‘Unlikely’ AstraZeneca-BMS mega-merger would be largest pharma deal ever
    If AstraZeneca and Bristol Myers Squibb were to successfully become one company, analysts say it could reset the current deal environment, which has picked up greatly in the first half of the year.
    biospace · 2mo ago
view all news mentions →
brand
Tagrisso
trade names
Tagrisso
generic
osimertinib mesylate
MOA
Epidermal growth factor receptor erbB1 inhibitor
indication
Non-Small Cell Lung Cancer
phase
marketed
approved
2015-11-13
Data sources
openFDA · ClinicalTrials.gov · OpenTargets
last refreshed 2h ago
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