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Generated: August 15, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021897

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NDA 021897 describes VIVITROL, which is a drug marketed by Alkermes and is included in one NDA. It is available from one supplier. There are sixteen patents protecting this drug. Additional details are available on the VIVITROL profile page.

The generic ingredient in VIVITROL is naltrexone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the naltrexone profile page.

Summary for 021897

Tradename:	VIVITROL
Applicant:	Alkermes
Ingredient:	naltrexone
Patents:	16
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 021897

Generic Entry Date for 021897^: ➤ Try a Free Trial* Constraining patent/regulatory exclusivity: ➤ Try a Free Trial Dosage: FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR

^*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.

Medical Subject Heading (MeSH) Categories for 021897

Narcotic Antagonists

Suppliers and Packaging for NDA: 021897

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897	NDA	Alkermes, Inc.	65757-300	N	65757-300-01

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR			Strength	380MG/VIAL
Approval Date:	Apr 13, 2006	TE:		RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Dec 30, 2018	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Try a Free Trial	Patent Expiration:	May 19, 2020	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Try a Free Trial	Patent Expiration:	Nov 12, 2019	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 021897

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	➤ Try a Free Trial	➤ Try a Free Trial
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	➤ Try a Free Trial	➤ Try a Free Trial
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	➤ Try a Free Trial	➤ Try a Free Trial
Alkermes	VIVITROL	naltrexone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	021897-001	Apr 13, 2006	➤ Try a Free Trial	➤ Try a Free 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 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.