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KYTRIL

NDA

GRANISETRON HYDROCHLORIDE | N020239 | HOFFMANN LA ROCHE INC

4 strengths0 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2015-P-1898 · 4 docket documents Hyman, Phelps & McNamara, P.C. filed this citizen petition under 21 C.F.R. § 10.25 and sections 505(b) and 505(w) of the FDC Act requesting that the FDA determine whether KYTRIL (granisetron HCl) Tablets at 1 mg and 2 mg strengths, approved under NDA 020305 and held by Hoffmann-La Roche, Inc., was v	505(q)	2015-05-28	Granted	Hyman, Phelps & McNamara, P.C.

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

API Supply Chain15 active DMFs5 inactive

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

WAVELENGTH ENTERPRISES LTDGRANISETRON HYDROCHLORIDE

DMF 138441998

CHONGQING CARELIFE PHARMACEUTICAL CO LTDGRANISETRON HYDROCHLORIDE USP NON-STERILE BULK DRUG SUBSTANCE

DMF 168382003

INKE SAGRANISETRON HYDROCHLORIDE

DMF 173462004

CIPLA LTDGRANISETRON HYDROCHLORIDE USP

DMF 177932004

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDGRANISETRON HYDROCHLORIDE, NON-STERILE BULK DRUG SUBSTANCE

DMF 190782005

NATCO PHARMA LTDGRANISETRON HYDROCHLORIDE

DMF 192152006

HUBEI HAOSUN PHARMACEUTICAL CO LTDGRANISETRON HYDROCHLORIDE (NON-STERILE)

DMF 193652006

WOCKHARDT LTDGRANISETRON HYDROCHLORIDE

DMF 197082006

TARO PHARMACEUTICAL INDUSTRIES LTDGRANISETRON HYDROCHLORIDE USP

DMF 199472006

ORBION PHARMACEUTICALS PRIVATE LTDGRANISETRON HYDROCHLORIDE

DMF 199672006

NATCO PHARMA LTDGRANISETRON HYDROCHLORIDE (INJECTABLE GRADE)

DMF 206782007

SCINOPHARM TAIWAN LTDGRANISETRON HYDROCHLORIDE

DMF 208692007

HIKMA PHARMACEUTICALSGRANISETRON HYDROCHLORIDE USP

DMF 252982011

SYN-TECH CHEM AND PHARM CO LTDGRANISETRON HYDROCHLORIDE USP

DMF 265042012

SWATI SPENTOSE PRIVATE LTDGRANISETRON HYDROCHLORIDE USP

DMF 351472020

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveGRANISETRON HYDROCHLORIDE USP

DMF 165602003

AMINO CHEMICALS LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 174762004

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 184262005

MYLAN LABORATORIES LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 190702005

HAMARI CHEMICALS LTDInactiveGRANISETRON HYDROCHLORIDE

DMF 235882010

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 19, 2011	SUPPL -23	View Letter (PDF)
Nov 12, 2009	SUPPL -21	View Letter (PDF)
Nov 30, 2005	SUPPL -18	View Letter (PDF)
Sep 21, 2004	SUPPL -16	View Letter (PDF)
Sep 21, 2004	SUPPL -17	View Letter (PDF)
Aug 25, 2004	SUPPL -15	View Letter (PDF)
Aug 16, 2002	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — EQ 3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Dec 29, 1993

No patent or exclusivity listings for this strength.

#002 — EQ 4MG BASE/4ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 11, 1994

#003 — EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 17, 2004

#004 — EQ 1MG BASE/ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Mar 11, 1994