Orange Book product · Brand (NDA)

ATELVIA

RISEDRONATE SODIUM

Brand (NDA)NDA 022560TE ABRX APIL

Oct 08, 2010

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 08, 2010
15 yr 11 mo ago
Patent 8246989 expires
Listed drug product patent expiration.
Jan 16, 2026
5 mo ago
Today
Patent 7645459 expires
Listed drug product patent expiration.
Jan 09, 2028
in 1 yr 7 mo
Patent 7645460 expires
Listed drug product patent expiration.
Jan 09, 2028
in 1 yr 7 mo

Active ingredient

RISEDRONATE SODIUM

Strength

35MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Application

NDA 022560

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
8246989	Jan 16, 2026	5 mo ago	Product
7645459	Jan 09, 2028	in 1 yr 7 mo	ProductU-662
7645460	Jan 09, 2028	in 1 yr 7 mo	ProductU-662