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Generated: September 18, 2019

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 thirteen 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:13
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021897
Generic Entry Date for 021897*:
Constraining patent/regulatory exclusivity:
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
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)

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 Free TrialPatent Expiration:May 19, 2020Product Flag?YSubstance Flag?Delist Request?
Patent:  Try a Free TrialPatent Expiration:Nov 12, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:  Try a Free TrialPatent Expiration:May 19, 2020Product Flag?YSubstance Flag?Delist Request?

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 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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