drug · protein
lutetium Lu 177 dotatate
Marketedupdated 3mo agoby Advanced Accelerator Applications SA🔗 ChEMBL
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 1Protein 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 Cancer
- —Italian Prospective Observational Study Assessing the Effectiveness and Outcomes Associated With Lutathera Treatment in GEP-NETs
- phase3Study to Evaluate the Efficacy and Safety of Lutathera in Patients With Grade 2 and Grade 3 Advanced GEP-NET
- —Post-Authorization Long-Term Safety Study of LUTATHERA
- —LUTATHERA Injection General Use Result Survey
- phase1Lutathera and ASTX727 in Neuroendocrine Tumours
- phase1Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery
- phase2Intra-arterial Hepatic (IAH) Infusion of Radiolabelled Somatostatin Analogs in GEP-NET Patients With Dominant Liver Metastases
Patent cliff
source: FDA Orange Bookfirst barrier falls
Apr 23, 2027
246 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)4.7y
- Oct 23, 2027PEDPediatric (6mo bonus)1.2y
- Apr 23, 2027NPPNew Product (3y)246d
News(8)
- Silence cashes in on ‘differentiated’ data; UK reaffirms support for childhood vaccinesSome analysts believe Silence’s polycythemia vera drug could be superior to a closely watched Takeda medicine. Elsewhere, the FDA spurned a radiopharmaceutical and AbCellera shares climbed to level…biopharma_dive · 7d ago
- FDA rejects ITM's radiopharma drug over manufacturing problemsThe FDA rejected ITM Isotope Technologies Munich’s radiopharmaceutical agent for neuroendocrine tumors because of manufacturing issues, delaying a potential challenger to Novartis’ approved drug Lu…endpoints · 9d ago
- ITM neuroendocrine tumor drug spurned by FDA over manufacturing qualmsThe FDA has denied ITM Isotopes Technologies’ lead pipeline candidate for a rare group of tumors due to qualms over the drug’s manufacturing.fiercebiotech · 9d ago
- Novartis scraps mid-stage radiopharma asset as Pluvicto soarsThe discontinued asset, being trialed for breast cancer and solid tumors, had yielded disappointing data, leading to Novartis’ decision to abandon development, according to a company spokesperson.biospace · 28d ago
- Novartis drops phase 2 radioligand therapy, but CEO’s commitment to modality ‘unchanged’Novartis has dropped a phase 2-stage radioligand therapy after the candidate disappointed in the clinic.fiercebiotech · 29d ago
- Novartis to acquire ADC developer in a deal worth up to $1.5BThe deal hands over two ADCs with a different mechanism of action targeting cell growth, and marks Novartis' entry into ADC development.biopharma_dive · 1mo ago
- Precision under pressure: Logistic solutions for nuclear medicine scalabilityRacing the clock: How precision logistics deliver life-saving nuclear medicine.biopharma_dive · 2mo ago
- Novartis' radioligand therapy Lutathera could soon face generic competitionThe radioligand field is on the cusp of a major competitive moment, as a rival looks to bring the first generic to a market that’s been dominated by Novartis. Radioligand therapy aims to bring the ...endpoints · 3mo ago
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