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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 24, 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 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, 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 fifty NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for granisetron

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Recent Clinical Trials for granisetron

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

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Recent Litigation for granisetron

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District Court Litigation
Case NameDate
Prostrakan, Inc. v. Actavis Laboratories UT, Inc.2016-01-15
ProStrakan, Inc. v. Actavis Laboratories UT, Inc.2016-01-13

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Pharmacology for granisetron
Medical Subject Heading (MeSH) Categories for granisetron
Synonyms for granisetron
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-[(1r,5s)-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-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-
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
DB00889
DL-166
DTXSID0023111
FT-0626805
Granisetron (JAN/USAN/INN)
Granisetron [USAN:INN:BAN:JAN]
Granisetronum
GTPL2300
HMS2089P14
HMS3715H17
Kevatril
Kevatril|||1-Methyl-N-[(3-endo)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3-carboxamide,
Q-101870
Sancuso
Sancuso (TN)
SCHEMBL34178
SCHEMBL4890
SCHEMBL4891
SR-05000001492
SR-05000001492-1
SR-05000001492-2
Sustol
UNII-WZG3J2MCOL
VA11035
W-5139
WZG3J2MCOL
ZINC100018852
ZINC100018854
ZINC347
Paragraph IV (Patent) Challenges for GRANISETRON
Tradename Dosage Ingredient NDA Submissiondate
SANCUSO FILM, EXTENDED RELEASE;TRANSDERMAL granisetron 022198 2015-10-09

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
Apotex Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride TABLET;ORAL 078843-001 Feb 27, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Roche KYTRIL granisetron hydrochloride INJECTABLE;INJECTION 020239-004 Mar 11, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bionpharma Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078880-001 Jun 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc GRANISETRON HYDROCHLORIDE granisetron hydrochloride INJECTABLE;INJECTION 078531-002 Apr 30, 2009 AP RX 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
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Medtronic
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Harvard Business School

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.