Viewing data from:

BRAFTOVI

NDA

ENCORAFENIB | N210496 | ARRAY BIOPHARMA INC

2 strengths13 unique patents3 unique exclusivities

Patent Timeline

13 unique patents, 3 exclusivities by expiration date

Active (13)TodayExclusivity

2027

2028

2029

2030

2031

2032

2033

Today

Feb. 27, 2030

Feb. 26, 2030

Jul. 23, 2029

Jul. 4, 2031

Nov. 21, 2032

Aug. 5, 2033

Aug. 27, 2030

Aug. 27, 2030

Nov. 21, 2032

Aug. 27, 2030

Aug. 27, 2030

Aug. 27, 2030

Nov. 21, 2032

I-928

Oct. 11, 2026

I-957

Dec. 20, 2027

ODE-445

Oct. 11, 2030

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Use of BRAF-Targeted Therapy After Surgery and Usual Chemotherapy for BRAF-Mutated Colon Cancer NCT05710406	Phase 2/3	Active	Alliance for Clinical Trials in Oncology	1	2023-08-16 → 2034-06-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Braftovi (2023)

Total Spending

$87.2M

Total Claims

6,166

Beneficiaries

1,328

Avg Cost/Unit

$101.78

Spending Trend

$26.8M(2019)→$55.9M(2020)→$85.2M(2021)→$100.5M(2022)→$87.2M(2023)

YoY Change:+12.2%

5yr CAGR:+10.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

MSN LABORATORIES PRIVATE LTDENCORAFENIB

DMF 357562021

APITORIA PHARMA PRIVATE LTDENCORAFENIB

DMF 366302021

VALARY LAB PRIVATE LTDENCORAFENIB

DMF 419022025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2026	SUPPL -21	View Letter (PDF)
Mar 4, 2026	SUPPL -19	View Letter (PDF)
Mar 14, 2025	SUPPL -18	View Letter (PDF)
Dec 26, 2024	SUPPL -17	View Letter (PDF)
Sep 16, 2024	SUPPL -16	View Letter (PDF)
Oct 16, 2023	SUPPL -15	View Letter (PDF)
Oct 13, 2023	SUPPL -14	View Letter (PDF)
Feb 15, 2022	SUPPL -13	View Letter (PDF)
Apr 10, 2020	SUPPL -6	View Letter (PDF)
Jun 4, 2019	SUPPL -3	View Letter (PDF)
Feb 13, 2019	SUPPL -1	View Letter (PDF)
Jul 6, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 50MG

RLD

10 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Jun 27, 2018

Patents (10)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8541575	Feb 26, 2030	—	Yes	Yes		—
8946250	Jul 23, 2029	—	Yes	Yes	—	—
9314464	Jul 4, 2031	—	—	—		—
9387208	Nov 21, 2032	—	—	Yes	—	—
9593099	Aug 27, 2030	—	Yes	—	—	—
9593100	Aug 27, 2030	—	—	Yes	—	—
9763941	Nov 21, 2032	—	—	—		—
9850229	Aug 27, 2030	—	—	—		—
9850230	Aug 27, 2030	—	—	—		—
10005761	Aug 27, 2030	—	—	—		—

Exclusivities (3)

Code	Date	Status
I-928	Oct 11, 2026	< 1 year
I-957	Dec 20, 2027	Active
ODE-445	Oct 11, 2030	Active

#002 — 75MG

RLD

13 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Jun 27, 2018