Viewing data from:

ZELBORAF

NDA

VEMURAFENIB | N202429 | HOFFMANN LA ROCHE INC

1 strength6 unique patents0 unique exclusivities

Patent Timeline

6 unique patents by expiration date

Expired (1)Expiring < 1yr (2)Active (3)Today

2027

2028

2029

2030

2031

2032

Today

Oct. 22, 2026

Jun. 20, 2029

Jun. 21, 2026

Aug. 2, 2026

Jul. 27, 2030

Jun. 6, 2032

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

2 trials from ClinicalTrials.gov — 2 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
KPMNG Study of MOlecular Profiling Guided Therapy Based on Genomic Alterations in Advanced Solid Tumors II NCT05525858	—	Recruiting	Seoul National University Bundang Hospital	1,000	2022-09-28 → 2027-03
DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial) - Master Screening Protocol NCT05722886	Phase 2/3	Recruiting	Cancer Research UK	825	2023-03-01 → 2029-10

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

Medicare Part D Spending

CMS annual spending data for Zelboraf (2023)

Total Spending

$13.0M

Total Claims

1,697

Beneficiaries

298

Avg Cost/Unit

$53.18

Spending Trend

$13.0M(2019)→$12.4M(2020)→$13.7M(2021)→$13.2M(2022)→$13.0M(2023)

YoY Change:+6.2%

5yr CAGR:+3.1%

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
May 19, 2020	SUPPL -19	View Letter (PDF)
Nov 9, 2017	SUPPL -16	View Letter (PDF)
Sep 19, 2017	SUPPL -14	View Letter (PDF)
Sep 19, 2017	SUPPL -15	View Letter (PDF)
Apr 18, 2017	SUPPL -12	View Letter (PDF)
Aug 31, 2016	SUPPL -9	View Letter (PDF)
May 11, 2016	SUPPL -10	View Letter (PDF)
Aug 12, 2015	SUPPL -8	View Letter (PDF)
Nov 28, 2014	SUPPL -6	View Letter (PDF)
Mar 20, 2014	SUPPL -4	View Letter (PDF)
Feb 11, 2014	SUPPL -5	View Letter (PDF)
Jul 5, 2013	SUPPL -2	View Letter (PDF)
Jul 5, 2013	SUPPL -3	View Letter (PDF)
Aug 17, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 240MG

RLD

6 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 17, 2011

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7504509	Oct 22, 2026	—	Yes	Yes	—	—
7863288	Jun 20, 2029	—	Yes	Yes	—	—
8143271	Jun 21, 2026	—	Yes	Yes	—	—
8470818	Aug 2, 2026	—	—	—		—
8741920	Jul 27, 2030	—	Yes	Yes	—	—
9447089	Jun 6, 2032	—	—	Yes	—	—