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Last Updated: April 28, 2024

Details for New Drug Application (NDA): 022445

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NDA 022445 describes SUSTOL, which is a drug marketed by Heron Theraps Inc and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the SUSTOL profile page.

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

Summary for 022445

Tradename:	SUSTOL
Applicant:	Heron Theraps Inc
Ingredient:	granisetron
Patents:	5
Formulation / Manufacturing:	see details

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022445

Generic Entry Date for 022445^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 NDA: 022445

Mechanism of Action	Serotonin 3 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 022445

Antiemetics
Serotonin Antagonists

Suppliers and Packaging for NDA: 022445

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445	NDA	Heron Therapeutics, Inc.	47426-101	47426-101-06	6 KIT in 1 CARTON (47426-101-06) / 1 SYRINGE, GLASS in 1 KIT / .4 mL in 1 SYRINGE, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS			Strength	10MG/0.4ML (10MG/0.4ML)
Approval Date:	Aug 9, 2016	TE:		RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	Sep 28, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PROPHYLACTIC TREATMENT OF NAUSEA AND VOMITING, INCLUDING PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED CHEMOTHERAPY
Patent:	⤷ Try a Trial	Patent Expiration:	Sep 28, 2024	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Try a Trial	Patent Expiration:	Sep 28, 2024	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OR PREVENTION OF NAUSEA AND VOMITING

Expired US Patents for NDA 022445

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Try a Trial	⤷ Try a Trial
Heron Theraps Inc	SUSTOL	granisetron	INJECTION, EXTENDED RELEASE;SUBCUTANEOUS	022445-001	Aug 9, 2016	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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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 verification 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.