Viewing data from:

ERIVEDGE

NDA

VISMODEGIB | N203388 | GENENTECH INC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2027

2028

2029

Today

7888364

Nov. 11, 2028

9278961

Dec. 15, 2028

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
GENENTECH, INC. et al v. SUN PHARMACEUTICAL INDUSTRIES LTD et al 2:2025cv11027 1 patentANDA 220393vismodegib	D.N.J.	2025-06-13	Active	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)NCT02465060	Phase 2	Active	National Cancer Institute (NCI)	6,452	2015-08-17 → 2026-12-31
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas NCT02523014	Phase 2	Recruiting	Alliance for Clinical Trials in Oncology	124	2015-09-28 → 2028-01
A Randomized Phase II Study of Cisplatin and Etoposide in Combination With Either Hedgehog Inhibitor GDC-0449 or IGF-1R MOAB IMC-A12 for Patients With Extensive Stage NCT00887159	Phase 2	Completed	National Cancer Institute (NCI)	168	2009-07-16 → 2016-11-15

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

Medicare Part D Spending

CMS annual spending data for Erivedge (2023)

Total Spending

$102.9M

Total Claims

7,735

Beneficiaries

1,719

Avg Cost/Unit

$492.89

Spending Trend

$122.6M(2019)→$138.1M(2020)→$140.2M(2021)→$124.8M(2022)→$102.9M(2023)

YoY Change:+5.8%

5yr CAGR:+4.9%

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

API Supply Chain5 active DMFs

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

SUN PHARMACEUTICAL INDUSTRIES LTDVISMODEGIB

DMF 412222025

MSN LABORATORIES PRIVATE LTDVISMODEGIB

DMF 412952025

SYNTHON BVVISMODEGIB

DMF 418692025

HETERO LABS LTDVISMODEGIB

DMF 421112025

ZYDUS LIFESCIENCES LTDVISMODEGIB

DMF 421572025

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Mar 28, 2023	SUPPL -17	View Letter (PDF)
Aug 3, 2020	SUPPL -16	View Letter (PDF)
Mar 28, 2019	SUPPL -14	View Letter (PDF)
Jan 22, 2019	SUPPL -12	View Letter (PDF)
Aug 4, 2017	SUPPL -11	View Letter (PDF)
Nov 8, 2016	SUPPL -10	View Letter (PDF)
May 22, 2015	SUPPL -8	View Letter (PDF)
May 22, 2015	SUPPL -6	View Letter (PDF)
May 22, 2015	SUPPL -7	View Letter (PDF)
May 22, 2015	SUPPL -5	View Letter (PDF)
Jan 31, 2012	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 150MG

RLD

2 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jan 30, 2012

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7888364	Nov 11, 2028	—	Yes	Yes	—	—
9278961	Dec 15, 2028	—	—	—		—