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Generated: February 17, 2019

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Granisetron - Generic Drug Details

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

Granisetron is the generic ingredient in six branded drugs marketed by Kyowa Kirin, Heron Theraps Inc, Akorn Inc, Aurobindo Pharma Ltd, Baxter Hlthcare Corp, Bluepharma, Cipla Ltd, 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 Pharm, and Teva Pharms, and is included in fifty NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Granisetron has fifty-six patent family members in thirty-two countries.

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

Pharmacology for granisetron
Medical Subject Heading (MeSH) Categories for granisetron
Synonyms for granisetron
1-Methyl-1H-indazole-3-carboxylic acid (9-methyl-9-aza-bicyclo[3.3.1]non-3-yl)-amide
1-METHYL-N-((1R,3R,5S)-9-METHYL-9-AZABICYCLO[3.3.1]NONAN-3-YL)-1H-INDAZOLE-3-CARBOXAMIDE
1-methyl-N-(9-methyl-9-azabicyclo[3.3.1]non-3-yl)-indazole-3-carboxamide
1-Methyl-N-(9-methyl-endo-9-azabicyclo(3.3.1)non-3-yl)-1H-indazole-3-carboxamide
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]-3-indazolecarboxamide
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-3-yl]indazole-3-carboxamide
1-methyl-N-[(1S,5R)-9-methyl-9-azabicyclo[3.3.1]nonan-7-yl]indazole-3-carboxamide
1-methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide
107007-99-8 (mono-hydrochloride)
109889-09-0
121061-98-1
124998-65-8
1H-Indazole-3-carboxamide, 1-methyl-N-(9-methyl-9-azabicyclo(3.3.1)non-3-yl)-, endo-
1H-INDAZOLE-3-CARBOXAMIDE, 1-METHYL-N-[(3-ENDO)-9-METHYL-9-AZABICYCLO[3.3.1]NON-3-YL]-
3702AH
889g090
A802101
AB00918713-07
AB07494
AC-8910
AC1NR4P1
AKOS025402424
AN-7538
APF 530
APF530
API0005490
BDBM50443668
BDBM50449636
BIDD:GT0272
BRL 43694
BRL 43964
BRL-43694
C07023
CCG-221158
CHEBI:5537
CHEBI:94501
CHEMBL1290003
D04370
D0J5KF
DB00889
DL-166
DTXSID0023111
ENDO-GRANISETRON
FT-0626805
GRANESETRON
Granisetron (JAN/USAN/INN)
Granisetron (USAN/INN)
Granisetron [USAN:INN:BAN:JAN]
Granisetron Monohydrochloride
Granisetronum
GTPL2300
HMS2089P14
Kevatril
Kevatril|||1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide,
Kytril (TN)
Q-101870
Sancuso
Sancuso (TN)
SCHEMBL34178
SCHEMBL4890
SCHEMBL4891
Sustol
UNII-WZG3J2MCOL
VA11035
W-5139
WZG3J2MCOL
ZINC100018852
ZINC100018854
ZINC347

US Patents and Regulatory Information for granisetron

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078808-001 Apr 29, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Asi GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 091137-002 Apr 9, 2010 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-001 Dec 29, 1993 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078221-001 Dec 31, 2007 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 077913-001 Jun 26, 2008 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

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US Department of Justice
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Medtronic
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