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  1. pharmadog
  2. ›drugs
  3. ›Erleada
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apalutamide

Marketedupdated 5mo ago
by $JNJ JOHNSON & JOHNSON
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • drugERLEADA60 co-mentions · 15 sources
  • tagApproval60 co-mentions · 15 sources
  • companyJanssen Biotech Inc30 co-mentions · 15 sources
  • tagSmall Molecule30 co-mentions · 15 sources

indications

investigational
Prostate Cancer

all catalysts(15)

approval · 15
Feb 14, 2018
approval
9y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Sep 17, 2019
approval
7y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Jul 10, 2020
approval
6y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Sep 1, 2020
approval
6y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Nov 20, 2020
approval
6y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Jul 14, 2021
approval
5y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Sep 7, 2021
approval
5y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Apr 26, 2022
approval
4y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Nov 8, 2022
approval
4y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Nov 8, 2022
approval
4y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Feb 17, 2023
approval
4y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Dec 19, 2023
approval
3y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Jul 9, 2024
approval
2y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Aug 2, 2024
approval
2y ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
Mar 5, 2026
approval
7mo ago
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
→
view all 15 catalysts →

Trials studying apalutamide

  • phase1A Study of JNJ-87189401 Combined With JNJ-78278343 for Advanced Prostate Cancerrecruitingn=355
  • phase2Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Canceractive not recruitingn=26
  • phase2Investigating SX-682 in Combination With Apalutamide in Metastatic Castration-resistant Prostate Cancerrecruitingn=78
  • phase3An Efficacy and Safety Study of Apalutamide (JNJ-56021927) in Combination With Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Participants With Chemotherapy-naive Metastatic Castration-resistant Prostate Cancer (mCRPC)active not recruitingn=982
  • phase3An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLASactive not recruitingn=1,503
  • phase3AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)recruitingn=670
  • phase2Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Canceractive not recruitingn=174
  • phase1A Study to Learn How Enzalutamide, Apalutamide and Bicalutamide Affect the Way Fezolinetant is Processed in Men With Prostate Cancernot yet recruitingn=56

Patent cliff

source: FDA Orange Book
first barrier falls
Mar 27, 2027
173 days

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

patents (28)

  • Jan 14, 2041method-of-use (U-4449)US 11723898
  • Jan 14, 2041method-of-use (U-4449)US 11723898
  • Jan 30, 2040method-of-use (U-3901)US 11963952
  • Jan 30, 2040method-of-use (U-3901)US 11963952
  • Jan 30, 2040method-of-use (U-4201)US 12303497
  • Jan 30, 2040method-of-use (U-4201)US 12303497
  • Apr 30, 2038method-of-use (U-3012)US 10702508
  • Apr 30, 2038method-of-use (U-3012)US 10702508
  • Dec 3, 2035formulationUS 12303493
  • Dec 3, 2035formulationUS 12303493
  • Sep 23, 2033method-of-use (U-3013)US 10849888
  • Sep 23, 2033method-of-use (U-3013)US 10849888
  • Sep 23, 2033method-of-use (U-2237)US 9884054
  • Sep 23, 2033method-of-use (U-2237)US 9884054
  • Sep 23, 2033method-of-use (U-2381)US RE49353
  • Sep 23, 2033method-of-use (U-2381)US RE49353
  • Sep 23, 2033method-of-use (U-4450)US RE50642
  • Sep 23, 2033method-of-use (U-4450)US RE50642
  • Jun 4, 2033compositionUS 9481663
  • Jun 4, 2033compositionUS 9481663
  • Sep 15, 2030compositionUS 84455073.9y
  • Sep 15, 2030compositionUS 84455073.9y
  • Mar 27, 2027method-of-use (U-2624)US 8802689173d
  • Mar 27, 2027method-of-use (U-2624)US 8802689173d
  • Mar 27, 2027compositionUS 9388159173d
  • Mar 27, 2027compositionUS 9388159173d
  • Mar 27, 2027formulationUS 9987261173d
  • Mar 27, 2027formulationUS 9987261173d

News(3)

  • J&J dips despite upbeat outlook; AstraZeneca, Spero cut China deals
    J&J’s shares ticked down as oncology sales missed expectations. Elsewhere, AstraZeneca bet $600 million on a lung cancer drug and a pair of biotechs snagged two of the year’s top venture rounds.
    biopharma_dive · 2mo ago
  • #ASCO26: Erleada succeeds in early-stage prostate cancer study, but questions remain
    CHICAGO — As part of a hormone therapy regimen for prostate cancer, J&J’s Erleada cut the risk of metastasis or death by 20% when given around surgery, researchers reported Sunday. Treatment with t…
    endpoints · 4mo ago
  • GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026
    We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.
    onclive · 4mo ago
brand
Erleada
generic
apalutamide [INN]
indication
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
phase
marketed
Data sources
openFDA · ClinicalTrials.gov
last refreshed 4h ago
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