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Last Updated: March 29, 2024

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 is one patent 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:1
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)
VIVITROL naltrexone FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 021897 NDA Alkermes, Inc. 65757-301 65757-301-01 1 KIT in 1 CARTON (65757-301-01) * 4 mL in 1 VIAL, GLASS (65757-303-02) * 4 mL in 1 VIAL, GLASS (65757-305-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULARStrength380MG/VIAL
Approval Date:Apr 13, 2006TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Oct 15, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
Patent:⤷  Try a TrialPatent Expiration:Oct 15, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ALCOHOL DEPENDENCE

Expired US Patents for NDA 021897

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

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