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  1. pharmadog
  2. ›drugs
  3. ›Orserdu
drug · small molecule
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elacestrant hydrochloride

Marketedupdated 3mo ago
by A. Menarini Industrie Farmaceutiche Riunite Srl🔗 ChEMBL
Approved
community read0 votes

Small molecule drug with a maximum clinical stage of Approval (across all indications), with an approval for male breast carcinoma and breast neoplasm and 1 investigational indication.

targets

Estrogen receptor

all catalysts(0)

nothing on the calendar yet

Patent cliff

source: FDA Orange Book
first barrier falls
Aug 18, 2026
3 days

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

patents (14)

  • Jan 5, 2038compositionUS 10385008
  • Jan 5, 2038compositionUS 10385008
  • Jan 5, 2038method-of-use (U-3523)US 10745343
  • Jan 5, 2038method-of-use (U-3523)US 10745343
  • Feb 28, 2037method-of-use (U-3523)US 11819480
  • Feb 28, 2037method-of-use (U-3523)US 11819480
  • Oct 3, 2036method-of-use (U-3524)US 10420734
  • Oct 3, 2036method-of-use (U-3524)US 10420734
  • Oct 10, 2034method-of-use (U-3524)US 10071066
  • Oct 10, 2034method-of-use (U-3524)US 10071066
  • Oct 10, 2034method-of-use (U-3524)US 11779552
  • Oct 10, 2034method-of-use (U-3524)US 11779552
  • Aug 18, 2026compositionUS 76121143d
  • Aug 18, 2026compositionUS 76121143d

FDA exclusivities (2)

  • Jan 27, 2028NCENew Chemical Entity (5y)1.5y
  • Jan 27, 2028NCENew Chemical Entity (5y)1.5y

News(2)

  • 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 · 3mo ago
  • Arvinas, Pfizer find new partner for ‘Protac’ breast cancer drug
    A deal with Rigel Pharmaceuticals ends months of uncertainty about the future of Veppanu, a first-of-its-kind, newly approved medicine with a murky financial outlook.
    biopharma_dive · 3mo ago
brand
Orserdu
trade names
Orserdu
generic
elacestrant hydrochloride
MOA
Estrogen receptor alpha degrader
indication
Metastatic Breast Cancer
phase
marketed
Data sources
ClinicalTrials.gov · OpenTargets
last refreshed just now
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