Orange Book product · Brand (NDA)

VIVITROL

NALTREXONE

Brand (NDA)NDA 021897RX ALKERMES

Apr 13, 2006

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 13, 2006
20 yr 6 mo ago
Today
Patent 7919499 expires
Listed method-of-use patent (U-1124) expiration.
Oct 15, 2029
in 3 yr 4 mo
Patent 7919499 expires
Listed method-of-use patent (U-1123) expiration.
Oct 15, 2029
in 3 yr 4 mo

Active ingredient

NALTREXONE

Strength

380MG/VIAL

Dosage form

FOR SUSPENSION, EXTENDED RELEASE

Route

INTRAMUSCULAR

TE code

Not listed

Application

NDA 021897

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7919499	Oct 15, 2029	in 3 yr 4 mo	U-1124
7919499	Oct 15, 2029	in 3 yr 4 mo	U-1123