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

patents (23)

Aug 5, 2033method-of-use (U-4051)US 9474754
Nov 21, 2032method-of-use (U-4051)US 10258622
Nov 21, 2032formulationUS 9387208
Nov 21, 2032formulationUS 9387208
Nov 21, 2032method-of-use (U-2335)US 9763941
Nov 21, 2032method-of-use (U-2335)US 9763941
Jul 4, 2031method-of-use (U-4051)US 93144644.9y
Jul 4, 2031method-of-use (U-2336)US 93144644.9y
Aug 27, 2030method-of-use (U-2335)US 100057614.0y
Aug 27, 2030method-of-use (U-4051)US 100057614.0y
Aug 27, 2030compositionUS 95930994.0y
Aug 27, 2030compositionUS 95930994.0y
Aug 27, 2030formulationUS 95931004.0y
Aug 27, 2030formulationUS 95931004.0y
Aug 27, 2030method-of-use (U-2337)US 98502294.0y
Aug 27, 2030method-of-use (U-2337)US 98502294.0y
Aug 27, 2030method-of-use (U-4051)US 98502304.0y
Aug 27, 2030method-of-use (U-2334)US 98502304.0y
Feb 27, 2030compositionUS RE495563.5y
Feb 26, 2030compositionUS 85415753.5y
Feb 26, 2030compositionUS 85415753.5y
Jul 23, 2029compositionUS 89462502.9y
Jul 23, 2029compositionUS 89462502.9y

FDA exclusivities (6)

Oct 11, 2030ODE-445Orphan Drug (7y)4.2y
Oct 11, 2030ODE-445Orphan Drug (7y)4.2y
Dec 20, 2027I-957Indication (3y)1.3y
Dec 20, 2027I-957Indication (3y)1.3y
Oct 11, 2026I-928Indication (3y)56d
Oct 11, 2026I-928Indication (3y)56d

News(2)

STAT+: Does Revolution Medicines’ pancreatic cancer drug have even greater potential?
Revolution Medicines' pancreatic cancer drug has not yet been approved — and already talk has shifted to how (and when) its use might be expanded.
stat · 2mo ago
Biomarker-Directed Therapies Move the GI Oncology Paradigm Beyond a One-Size-Fits-All Approach: With Michael J. Pishvaian, MD, PhD
Michael J. Pishvaian, MD, PhD discusses how biomarker-directed strategies, including HER2, CLDN18.2, and KRAS inhibition, are transforming GI cancer care.
onclive · 3mo ago

brand

Braftovi

generic

encorafenib

MOA

12.1 Mechanism of Action Encorafenib is a kinase inhibitor that targets BRAF V600E, as well as wild-type BRAF and CRAF in in vitro cell-free assays with IC 50 values of 0.35, 0.47, and 0.3 nM, respectively. Mutations in the BRAF gene, such as BRAF V600E, can result in constitutively activated BRAF kinases that may stimulate tumor cell growth. Encorafenib was also able to bind to other kinases in vitro including JNK1, JNK2, JNK3, LIMK1, LIMK2, MEK4, and STK36 and reduce ligand binding to these kinases at clinically achievable concentrations (≤0.9 µM). Encorafenib inhibited in vitro growth of tumor cell lines expressing BRAF V600 E, D, and K mutations. In mice implanted with tumor cells expressing BRAF V600E , encorafenib induced tumor regressions associated with RAF/MEK/ERK pathway suppression. Encorafenib and binimetinib target two different kinases in the RAS/RAF/MEK/ERK pathway. Compared with either drug alone, coadministration of encorafenib and binimetinib resulted in greater anti-proliferative activity in vitro in BRAF mutation-positive cell lines and greater anti-tumor activity with respect to tumor growth inhibition in BRAF V600E mutant human melanoma xenograft studies in mice. Additionally, the combination of encorafenib and binimetinib delayed the emergence of resistance in BRAF V600E mutant human melanoma xenografts in mice compared to either drug alone. In a BRAF V600E mutant NSCLC patient-derived xenograft model in mice, coadministration of encorafenib and binimetinib resulted in greater anti-tumor activity compared to binimetinib alone, with respect to tumor growth inhibition. Increased tumor growth delay after dosing cessation was also observed with the coadministration compared to either drug alone. In the setting of BRAF-mutant CRC, induction of EGFR-mediated MAPK pathway activation has been identified as a mechanism of resistance to BRAF inhibitors. Combinations of a BRAF inhibitor and agents targeting EGFR have been shown to overcome this resistanc

indication

Metastatic Colorectal Cancer

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 16m ago

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encorafenib

Marketedupdated 3mo ago

by Array BioPharma Inc

Approved

community read0 votes

🐶 often sniffed alongside

top 7

Small molecule drug with a maximum clinical stage of Approval (across all indications), with 4 approved and 5 investigational indications.

indications

investigational

NSCLC

all catalysts(12)

approval · 12

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

BRAFTOVI (ENCORAFENIB) — FDA approval

encorafenib

→

view all 12 catalysts →

Trials studying encorafenib

phase2A Study of Encorafenib Plus Cetuximab Taken Together With Pembrolizumab Compared to Pembrolizumab Alone in People With Previously Untreated Metastatic Colorectal Canceractive not recruitingn=108
phase2Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancercompletedn=95
phase1PF-07284892 in Participants With Advanced Solid Tumorsterminatedn=53
phase4Surgical or Radiotherapeutic Intervention Concerning Large Singular Stable to Progressive Metastases in Patients With BRAFV600-mutated Melanoma Receiving Treatment With Encorafenib + Binimetinibwithdrawn
—UK ENcorafenib and BInimetinib Real-world Study in Melanomaactive not recruitingn=50
phase4The FLOTILLA Study: Providing Continued Access to The Study Medicines Encorafenib and Binimetinib for Participants in Prior Clinical Trialsrecruitingn=46
phase3A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanomaactive not recruitingn=257
phase2Binimetinib Encorafenib Pembrolizumab +/- Stereotactic Radiosurgery in BRAFV600 Melanoma With Brain Metastasisactive not recruitingn=10

more trials →

Patent cliff

source: FDA Orange Book

first barrier falls

Oct 11, 2026

56 days

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

patents (23)

Aug 5, 2033method-of-use (U-4051)US 9474754
Nov 21, 2032method-of-use (U-4051)US 10258622
Nov 21, 2032formulationUS 9387208
Nov 21, 2032formulationUS 9387208
Nov 21, 2032method-of-use (U-2335)US 9763941
Nov 21, 2032method-of-use (U-2335)US 9763941
Jul 4, 2031method-of-use (U-4051)US 93144644.9y
Jul 4, 2031method-of-use (U-2336)US 93144644.9y
Aug 27, 2030method-of-use (U-2335)US 100057614.0y
Aug 27, 2030method-of-use (U-4051)US 100057614.0y
Aug 27, 2030compositionUS 95930994.0y
Aug 27, 2030compositionUS 95930994.0y
Aug 27, 2030formulationUS 95931004.0y
Aug 27, 2030formulationUS 95931004.0y
Aug 27, 2030method-of-use (U-2337)US 98502294.0y
Aug 27, 2030method-of-use (U-2337)US 98502294.0y
Aug 27, 2030method-of-use (U-4051)US 98502304.0y
Aug 27, 2030method-of-use (U-2334)US 98502304.0y
Feb 27, 2030compositionUS RE495563.5y
Feb 26, 2030compositionUS 85415753.5y
Feb 26, 2030compositionUS 85415753.5y
Jul 23, 2029compositionUS 89462502.9y
Jul 23, 2029compositionUS 89462502.9y

FDA exclusivities (6)

Oct 11, 2030ODE-445Orphan Drug (7y)4.2y
Oct 11, 2030ODE-445Orphan Drug (7y)4.2y
Dec 20, 2027I-957Indication (3y)1.3y
Dec 20, 2027I-957Indication (3y)1.3y
Oct 11, 2026I-928Indication (3y)56d
Oct 11, 2026I-928Indication (3y)56d

News(2)

STAT+: Does Revolution Medicines’ pancreatic cancer drug have even greater potential?
Revolution Medicines' pancreatic cancer drug has not yet been approved — and already talk has shifted to how (and when) its use might be expanded.
stat · 2mo ago
Biomarker-Directed Therapies Move the GI Oncology Paradigm Beyond a One-Size-Fits-All Approach: With Michael J. Pishvaian, MD, PhD
Michael J. Pishvaian, MD, PhD discusses how biomarker-directed strategies, including HER2, CLDN18.2, and KRAS inhibition, are transforming GI cancer care.
onclive · 3mo ago

brand

Braftovi

generic

encorafenib

MOA

indication

Metastatic Colorectal Cancer

phase

marketed

Data sources

openFDA · ClinicalTrials.gov

last refreshed 16m ago

Found something off?

comments(0)

5-min edit window · permanent after that

no comments yet — first sniff?

encorafenib

🐶 often sniffed alongside

indications

all catalysts(12)

Trials studying encorafenib

Patent cliff

patents (23)

FDA exclusivities (6)

News(2)

Report a data issue

comments(0)

encorafenib

🐶 often sniffed alongside

indications

all catalysts(12)

Trials studying encorafenib

Patent cliff

patents (23)

FDA exclusivities (6)

News(2)

Report a data issue

comments(0)