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SUSTOL

NDA

GRANISETRON | N022445 | HERON THERAPEUTICS 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

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

63 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 47 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cisplatin Disposition and Kidney Injury NCT03817970	Phase 3	Active	University of Colorado, Denver	72	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
Granisetron Transdermal Patch for Prevention of Postoperative Nausea and Vomiting NCT02457195	Phase 2	Completed	Milton S. Hershey Medical Center	50	2016-02 → 2018-02-19
AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors NCT00415103	Phase 4	Completed	PETHEMA Foundation	196	2006-11 → 2009-09
A Single Dose, 4-Period, 2-Treatment Replicate Design Bioequivalency Study of Granisetron Hydrochloride 1 mg Tablets Under Fasting Conditions NCT00618254	N/A	Completed	Roxane Laboratories	32	2005-03 → 2005-04
Granisetron 1 mg Tablets, Non-fasting NCT00834522	Phase 1	Completed	Teva Pharmaceuticals USA	80	2005-07 → 2005-07
An Investigation on the Effect of Age and BMI on the Pharmacokinetics of Transdermal Granisetron NCT00868764	Phase 1	Completed	Kyowa Kirin Co., Ltd.	60	2009-04 → 2009-09
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
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

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$694.07

Highest Price

$694.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
47426-0101-06SUSTOL 10MG/0.4ML INJ,SYRINGE KIT	$694.07	FSS	Heron Therapeutics, Inc.	03/14/2026
47426-0101-06SUSTOL 10MG/0.4ML INJ,SYRINGE KIT	$694.07	Big4	Heron Therapeutics, Inc.	03/14/2026

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

Medicare Part D Spending

CMS annual spending data for Sustol (2024)

Total Spending

$112K

Total Claims

123

Beneficiaries

Avg Cost/Unit

$1848.35

Spending Trend

$39K(2019)→$23K(2020)→$45K(2021)→$95K(2022)→$88K(2023)→$112K(2024)

YoY Change:-5.4%

5yr CAGR:+3.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Sustol (2024)

Total Spending

$6.6M

Total Claims

12,286

Beneficiaries

2,665

ASP Price

$5.61

Spending Trend

$11.3M(2019)→$1.2M(2020)→$3.5M(2021)→$4.4M(2022)→$6.6M(2023)→$6.6M(2024)

YoY Change:-6.8%

5yr CAGR:+36.3%

HCPCS: J1627 — Injection, granisetron, extended-release, 0.1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

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

3 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2026	SUPPL -14	View Letter (PDF)
May 26, 2023	SUPPL -10	View Letter (PDF)
Aug 9, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/0.4ML (10MG/0.4ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;SUBCUTANEOUS | Approved: Aug 9, 2016

No patent or exclusivity listings for this strength.