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SANCUSO

NDA

GRANISETRON | N022198 | APOTEX INC

1 strength0 unique patents0 unique exclusivities

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

64 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 48 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cisplatin Disposition and Kidney Injury NCT03817970	Phase 3	Active	University of Colorado, Denver	45	2019-11-15 → 2027-12-31
BMT-08: A Comparative Effectiveness Study of Transdermal Granisetron to Ondansetron NCT04150614	Phase 4	Recruiting	University of Illinois at Chicago	90	2020-05-14 → 2026-07
To Study the Safety and Effectiveness of a Granisetron Patch to Treat Chemotherapy-Induced Nausea and Vomiting (CINV)NCT00273468	Phase 3	Completed	Kyowa Kirin Co., Ltd.	630	2006-01 → 2006-10
PK, Tolerability and Safety of the Co-administration of Sancuso® (Transdermal Granisetron) and IV Granisetron NCT00873197	Phase 1	Completed	Kyowa Kirin Co., Ltd.	12	2009-04 → 2009-05
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy NCT00231478	Phase 4	Completed	Hoffmann-La Roche	171	2007-04 → 2007-12
Safety and Efficacy of Palonosetron in Preventing Chemotherapy-induced Nausea and Vomiting NCT00503386	Phase 2	Completed	Hangzhou Jiuyuan Gene Engineering Co. Ltd.,	144	2006-04 → 2006-10
Safety and Pharmacokinetics of Sancuso and IV Granisetron in Patients Aged 13 to 17 Years NCT01596400	Phase 1	Completed	Kyowa Kirin Pharmaceutical Development Ltd	19	2012-05 → 2016-12
Ph3 Safety/Efficacy Study of Rolapitant for the Prevention of CINV in Subjects Receiving Highly Emetogenic Chemotherapy NCT01500213	Phase 3	Completed	Tesaro, Inc.	555	2012-02 → 2014-03
Combination of Cabazitaxel With Prednisolone With Primary Prophylaxis With PEG-G-CSF in Treatment of Patients With Prostate Cancer NCT02441894	Phase 4	Completed	Sanofi	21	2015-04 → 2016-11
An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients NCT00666783	Phase 2	Completed	Xijing Hospital	208	—

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 1 NDC

Highest NADAC/Unit

$686.64

per ea

Lowest NADAC/Unit

$686.64

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
66220063731SANCUSO 3.1 MG/24 HR PATCH	$686.64	EA	Brand	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 1 NDC (1 FSS)

Lowest Price

$475.74

Highest Price

$475.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
66220-0637-31SANCUSO 3.1MG/24HR PATCH	$475.74	FSS	Cumberland Pharmaceuticals, Inc.	02/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Sancuso (2024)

Total Spending

$6.6M

Total Claims

3,171

Beneficiaries

1,220

Avg Cost/Unit

$669.52

Spending Trend

$9.2M(2019)→$8.0M(2020)→$7.6M(2021)→$7.2M(2022)→$6.8M(2023)→$6.6M(2024)

YoY Change:-3.5%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs1 inactive

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

CIPLA LTDGRANISETRON USP

DMF 188202005

INKE SAGRANISETRON BASE

DMF 217902008

HUBEI HAOSUN PHARMACEUTICAL CO LTDGRANISETRON BASE

DMF 220892008

WAVELENGTH ENTERPRISES LTDGRANISETRON BASE

DMF 223112008

DR REDDYS LABORATORIES LTDGRANISETRON USP

DMF 231282009

SYN-TECH CHEM AND PHARM CO LTDGRANISETRON

DMF 259802012

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveGRANISETRON

DMF 164702003

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Sep 17, 2024	SUPPL -23	View Letter (PDF)
Jan 30, 2023	SUPPL -19	View Letter (PDF)
May 1, 2020	SUPPL -20	View Letter (PDF)
Oct 1, 2015	SUPPL -3	View Letter (PDF)
Sep 23, 2014	SUPPL -12	View Letter (PDF)
Sep 28, 2011	SUPPL -5	View Letter (PDF)
Sep 16, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.1MG/24HR

RLD

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Sep 12, 2008

No patent or exclusivity listings for this strength.