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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Medtronic
Colorcon
Federal Trade Commission
Queensland Health
Dow
Chinese Patent Office
Harvard Business School
AstraZeneca

Generated: July 16, 2018

DrugPatentWatch Database Preview

SUSTOL Drug Profile

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Which patents cover Sustol, and what generic alternatives are available?

Sustol is a drug marketed by Heron Theraps Inc and is included in one NDA. There are six patents protecting this drug.

This drug has sixteen patent family members in ten countries.

The generic ingredient in SUSTOL is granisetron. There are twenty-six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the granisetron profile page.
Summary for SUSTOL
International Patents:16
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 34
Patent Applications: 4,040
Formulation / Manufacturing:see details
DailyMed Link:SUSTOL at DailyMed
Drug patent expirations by year for SUSTOL
Generic Entry Opportunity Date for SUSTOL
Generic Entry Date for SUSTOL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage::
INJECTION, EXTENDED RELEASE;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for SUSTOL
Medical Subject Heading (MeSH) Categories for SUSTOL
Synonyms for SUSTOL
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
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
UNII-WZG3J2MCOL
VA11035
W-5139
WZG3J2MCOL
ZINC100018852
ZINC100018854
ZINC347

US Patents and Regulatory Information for SUSTOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Heron Theraps Inc SUSTOL granisetron INJECTION, EXTENDED RELEASE;SUBCUTANEOUS 022445-001 Aug 9, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Non-Orange Book US Patents for SUSTOL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,861,068 Pharmaceutical compositions using semi-solid delivery vehicle ➤ Try a Free Trial
8,252,306 Process for preparing a semi-solid delivery vehicle comprising granisetron ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
US Army
Teva
Julphar
Argus Health
Medtronic
Farmers Insurance
Cerilliant
Federal Trade Commission

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