Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Moodys
Merck
Boehringer Ingelheim
Johnson and Johnson
McKinsey
Mallinckrodt

Last Updated: November 14, 2019

DrugPatentWatch Database Preview

Granisetron hydrochloride - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

What are the generic drug sources for granisetron hydrochloride and what is the scope of patent protection?

Granisetron hydrochloride is the generic ingredient in four branded drugs marketed by Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bionpharma Inc, Cipla Ltd, Dr Reddys, Fresenius Kabi Usa, Hikma Farmaceutica, Luitpold, Mylan Asi, Mylan Labs Ltd, Sandoz Inc, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Roche, Pediatrx, Apotex Inc, Barr, Chartwell Molecular, Dr Reddys Labs Ltd, Epic Pharma Llc, Mylan, Natco Pharma, Orchid Hlthcare, Taro, and Teva Pharms, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for granisetron hydrochloride. Fourteen suppliers are listed for this compound.

Recent Clinical Trials for granisetron hydrochloride

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

SponsorPhase
Heron TherapeuticsPhase 2
University of Alabama at BirminghamPhase 2
Northwell HealthPhase 1/Phase 2

See all granisetron hydrochloride clinical trials

Recent Litigation for granisetron hydrochloride

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 granisetron hydrochloride litigation

Pharmacology for granisetron hydrochloride
Synonyms for granisetron hydrochloride
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 (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
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 GRANISETRON HYDROCHLORIDE
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 granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
West-ward Pharms Int GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077187-001 Jun 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 203454-001 Apr 4, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Akorn Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 079078-001 Sep 14, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Hikma Farmaceutica GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078629-001 Dec 23, 2009 AP RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms Usa GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077963-001 Jan 3, 2008 DISCN No 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 granisetron hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993   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 020239-004 Mar 11, 1994   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-002 Mar 11, 1994   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride TABLET;ORAL 020305-001 Mar 16, 1995   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Baxter
McKinsey
AstraZeneca
Johnson and Johnson
McKesson
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.