drug
apalutamide
Marketedupdated 3mo agoby $JNJ JOHNSON & JOHNSON
Approvedcommunity read0 votes
🐶 often sniffed alongside
top 4indications
investigational
Prostate Cancer
all catalysts(15)
approval · 15
Feb 14, 2018
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Sep 17, 2019
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Jul 10, 2020
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Sep 1, 2020
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Nov 20, 2020
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Jul 14, 2021
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Sep 7, 2021
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Apr 26, 2022
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Nov 8, 2022
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Nov 8, 2022
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Feb 17, 2023
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Dec 19, 2023
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Jul 9, 2024
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Aug 2, 2024
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Mar 5, 2026
approval
ERLEADA (APALUTAMIDE) — FDA approval
apalutamide
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Trials studying apalutamide
- phase2Genomic Biomarker-Selected Umbrella Neoadjuvant Study for High Risk Localized Prostate Cancer
- phase3A Study of Apalutamide in Participants With High-Risk, Localized or Locally Advanced Prostate Cancer Who Are Candidates for Radical Prostatectomy
- phase2Advanced ChemoHormonal Therapy for Treatment Naive Metastatic Prostate Cancer
- phase3An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS
- phase1A Study of Androgen Receptor (AR) Antagonist Apalutamide in Chinese Participants With Metastatic Castration-Resistant Prostate Cancer
- phase2Abiraterone, Enzalutamide, or Apalutamide in Castrate-sensitive Prostate Cancer.
- 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)
- phase3A Study of Apalutamide (ARN-509) in Men With Non-Metastatic Castration-Resistant Prostate Cancer
Patent cliff
source: FDA Orange Bookfirst barrier falls
Mar 27, 2027
218 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 84455074.1y
- Sep 15, 2030compositionUS 84455074.1y
- Mar 27, 2027method-of-use (U-2624)US 8802689218d
- Mar 27, 2027method-of-use (U-2624)US 8802689218d
- Mar 27, 2027compositionUS 9388159218d
- Mar 27, 2027compositionUS 9388159218d
- Mar 27, 2027formulationUS 9987261218d
- Mar 27, 2027formulationUS 9987261218d
News(3)
- J&J dips despite upbeat outlook; AstraZeneca, Spero cut China dealsJ&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 · 1mo ago
- #ASCO26: Erleada succeeds in early-stage prostate cancer study, but questions remainCHICAGO — 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 · 2mo ago
- GU Cancer Experts Highlight Top Abstracts to Watch During ASCO 2026We spoke with leading voices in GU oncology to see which presentations they are most looking forward to during the 2026 ASCO Annual Meeting.onclive · 3mo ago
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