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  1. pharmadog
  2. ›drugs
  3. ›Lutathera
drug · protein
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lutetium Lu 177 dotatate

Marketedupdated 5mo ago
by Advanced Accelerator Applications SA🔗 ChEMBL
Approved
community read0 votes

🐶 often sniffed alongside

top 1
  • tagRadioligand Therapy2 co-mentions · 1 sources

Protein drug with a maximum clinical stage of Approval (across all indications), with an approval for neuroendocrine neoplasm and neuroendocrine carcinoma and 7 investigational indications.

targets

Somatostatin receptor

all catalysts(0)

nothing on the calendar yet

Trials studying lutetium Lu 177 dotatate

  • phase2177Lu-DOTATATE for the Treatment of Stage IV or Recurrent Breast Cancerrecruitingn=10
  • —Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETsactive not recruitingn=164
  • phase3Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NETactive not recruitingn=226
  • —Post-Authorization Long-Term Safety Study of LUTATHERAactive not recruitingn=1,014
  • —LUTATHERA Injection General Use Result Surveycompletedn=347
  • phase1Lutathera and ASTX727 in Neuroendocrine Tumoursrecruitingn=27
  • phase1Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgeryrecruitingn=10
  • phase2Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastasesrecruitingn=23

Patent cliff

source: FDA Orange Book
first barrier falls
Apr 23, 2027
205 days

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

patents (18)

  • Jan 25, 2039patentUS 10596276*PED
  • Jan 25, 2039patentUS 10596278*PED
  • Jan 25, 2039patentUS 11904027*PED
  • Jan 25, 2039patentUS 12144873*PED
  • Jan 25, 2039patentUS 12151003*PED
  • Jan 25, 2039patentUS 12161732*PED
  • Jan 25, 2039patentUS 12168063*PED
  • Jan 25, 2039patentUS 12415003*PED
  • Jan 25, 2039patentUS 12491272*PED
  • Jul 25, 2038formulationUS 10596276
  • Jul 25, 2038formulationUS 10596278
  • Jul 25, 2038formulationUS 11904027
  • Jul 25, 2038method-of-use (U-4036)US 12144873
  • Jul 25, 2038formulationUS 12151003
  • Jul 25, 2038formulationUS 12161732
  • Jul 25, 2038formulationUS 12168063
  • Jul 25, 2038method-of-use (U-4036)US 12415003
  • Jul 25, 2038method-of-use (U-4036)US 12491272

FDA exclusivities (4)

  • Oct 23, 2031PEDPediatric (6mo bonus)
  • Apr 23, 2031ODE-479Orphan Drug (7y)4.6y
  • Oct 23, 2027PEDPediatric (6mo bonus)1.1y
  • Apr 23, 2027NPPNew Product (3y)205d

News(10)

  • 3 steps for taking on Novartis in radiopharma: Curium up first
    To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and win market share.
    biospace · 11h ago
  • Novartis bets up to $900M for radioligand therapy from China’s BoomRay
    Novartis is the current radiopharma leader with two FDA-approved therapies in Pluvicto and Lutathera.
    biospace · 6d ago
  • Novartis secures new radioligand in $900M deal as competition strengthens
    As an imposing new competitor begins to take shape, radiopharma leader Novartis has beefed up its pipeline by licensing a preclinical radioligand therapy from a specialist Chinese biotech.
    fiercebiotech · 7d ago
  • Western licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    biospace · 8d ago
  • Sleuth forecasts 2027 jump in Western license deals for Chinese radioligand therapies
    Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
    biospace · 8d ago
  • Telix buys ITM for $1.65B in ‘supercritical’ radiopharma M&A
    Aside from its manufacturing and distribution footprint, ITM Isotope Technologies Munich will give Telix Pharmaceuticals the late-stage ITM-11, being developed for gastroenteropancreatic neuroendoc…
    biospace · 8d ago
  • Telix buys ITM in bid to create a ‘radiopharmaceutical powerhouse’
    Worth $1.65 billion up front, the deal combines two large pipelines and manufacturing networks, helping Telix potentially “corner the industry” for radiopharmaceuticals, one analyst wrote.
    biopharma_dive · 8d ago
  • Analysts ‘extremely bullish’ as Telix beams into Novartis’ territory with $1.6B ITM acquisition
    Telix has struck a deal to buy ITM Isotope Technologies Munich for $1.65 billion upfront, securing an R&D pipeline led by a rival to Novartis’ Lutathera and a radiopharmaceutical supply network.
    fiercebiotech · 8d ago
  • Novo explores macrocycles’ potential in $1.4B cardiometabolic pact with Danish biotech
    Novo’s race to rejuvenate its cardiometabolic portfolio has seen the rebranded Danish pharma pen a $1.4 billion biobucks pact with oral macrocycle drug start-up Orbis Medicines.
    fiercebiotech · 13d ago
  • FDA clears first generic radioligand drug; Sionna turns to layoffs
    A Lutathera copycat has become the first “radioligand equivalent” cleared by regulators. Elsewhere, Novo dropped the “Nordisk” from its name and a novel RNAi drug showed early promise.
    biopharma_dive · 13d ago
view all news mentions →
brand
Lutathera
trade names
Lutathera
generic
lutetium Lu 177 dotatate
MOA
Somatostatin receptor binding agent
indication
Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET)
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed 1h ago
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