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Generated: December 13, 2017

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 nineteen 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:1
Applicant:1
Ingredient:1
Patents:19
Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 021897

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 65757-300-01 1 KIT in 1 CARTON (65757-300-01) * 4 mL in 1 VIAL, GLASS (65757-302-02) * 4 mL in 1 VIAL, GLASS (65757-304-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength380MG/VIAL
Approval Date:Apr 13, 2006TE:RLD:Yes
Patent:► SubscribePatent Expiration:May 2, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:May 2, 2017Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Dec 30, 2018Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 021897

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
AlkermesVIVITROLnaltrexoneFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
AlkermesVIVITROLnaltrexoneFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
AlkermesVIVITROLnaltrexoneFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
AlkermesVIVITROLnaltrexoneFOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR021897-001Apr 13, 2006► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Healthtrust
Covington
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Harvard Business School
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