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Last Updated: December 5, 2019

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KYTRIL Drug Profile

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Which patents cover Kytril, and when can generic versions of Kytril launch?

Kytril is a drug marketed by Roche and is included in three NDAs.

The generic ingredient in KYTRIL is granisetron hydrochloride. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the granisetron hydrochloride profile page.

Drug patent expirations by year for KYTRIL
Recent Clinical Trials for KYTRIL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Rutgers UniversityN/A
Memorial Sloan Kettering Cancer CenterN/A
University of Colorado, DenverN/A

See all KYTRIL clinical trials

Recent Litigation for KYTRIL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc.2015-12-04
HELSINN HEALTHCARE S.A. v. HOSPIRA, INC.2015-03-23
HELSINN HEALTHCARE S.A. v. DR. REDDY'S LABORATORIES, LTD.2011-07-08

See all KYTRIL litigation

Synonyms for KYTRIL
007G998
007M998
1-METHYL-1H-INDAZOLE-3-CARBOXYLIC ACID (9-METHYL-9-AZA-BICYCLO[3.3.1]NON-3-YL)-AMIDE HYDROCHLORIDE
1-methyl-N-((1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide hydrochloride
1-methyl-N-((1R,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide hydrochloride
1-Methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1H-indazole-3-carboxamide hydrochloride
1-methyl-n-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-1h-indazole-3-carboxamide hydrochloride(1:1)
1-METHYL-N-(9-METHYL-9-AZABICYCLO[3.3.1]NON-3-YL)-INDAZOLE-3-CARBOXAMIDE HCL
1-Methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-indazole-3-carboxamide hydrochloride
1-Methyl-N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)-1H-indazole-3-carboxamide hydrochloride
1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]nonan-3-yl)indazole-3-carboxamide hydrochloride
1-Methyl-N-(9-methyl-endo-9-azabicyclo(3.3.1)non-3-yl)-1H-indazole-3-carboxamide monohydrochloride
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]-3-indazolecarboxamide hydrochloride
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]indazole-3-carboxamide hydrochloride
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]indazole-3-carboxamide;hydrochloride
1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide hydrochloride
1044956-47-9
107007-99-8
109889-09-0 (Parent)
1H-Indazole-3-carboxamide, 1-methyl-N-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-, monohydrochloride, endo-
1H-Indazole-3-carboxamide, 1-methyl-N-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-,monohydrochloride, endo-
318F6L70J8
A801552
AB0012545
AB0105685
AB2000059
AB53971
AC-478
AC1L22XJ
AC1OCEWF
AC1Q3DY9
AKOS015894931
AKOS025311206
ALM-101
AN-5268
API0002865
AS-12882
BC208011
BCP02186
BCP9000731
BEMA-Granisetron
BRL 43694A
BRL-43694A
C18H24N4O.HCl
CAS-107007-99-8
CCG-101117
CCG-213056
CHEBI:5538
CHEMBL1237080
CHEMBL1900758
CPD000469138
CS-1510
D00677
DSSTox_CID_28983
DSSTox_GSID_49057
DSSTox_RID_83248
DTXSID7049057
endo-1-Methyl-N-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-1H-indazole-3-carboxamide hydrochloride
FT-0082684
FT-0626806
G0401
Granisertron hydrochloride
Granisetron (Hydrochloride)
Granisetron HCl
Granisetron hydrochloride
Granisetron hydrochloride (JAN/USAN)
Granisetron hydrochloride [USAN:USP]
Granisetron hydrochloride [USAN]
Granisetron hydrochloride preservative free
Granisetron hydrochloride, >=98% (HPLC), solid
Granisetron hydrochloride, European Pharmacopoeia (EP) Reference Standard
Granisetron Hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Granisetron hydrochloride, United States Pharmacopeia (USP) Reference Standard
Granisetron Hydrocholride
Granisetron hydrocholride,(S)
Granisetron-MDTS
Granisol
HY-B0071A
I06-0077
I06-077
J-001688
Kytril (TN)
Kytril Injection
LP01173
LS-81436
MCULE-2461768801
MFCD01747034
MLS001401373
MLS003915623
NC00367
NCGC00183873-01
NCGC00261858-01
NSC-672814
NSC-759839
NSC672814
NSC759839
Pharmakon1600-01502365
QYZRTBKYBJRGJB-UHFFFAOYSA-N
s1345
SAM001246527
Sancuso
SC-17029
SCHEMBL33433
SCHEMBL34177
SCHEMBL34179
SMR000469138
SMR001456513
SyB L-0701
TL8000249
Tox21_113607
Tox21_501173
UNII-318F6L70J8
W-5272
Paragraph IV (Patent) Challenges for KYTRIL
Tradename Dosage Ingredient NDA Submissiondate
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2007-03-08
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2004-07-19
KYTRIL INJECTABLE;INJECTION granisetron hydrochloride 020239 2004-06-01

US Patents and Regulatory Information for KYTRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride TABLET;ORAL 020305-002 Jun 15, 1998 DISCN Yes No   Start Trial   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for KYTRIL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride SOLUTION;ORAL 021238-001 Jun 27, 2001   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-003 Sep 17, 2004   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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