Orange Book product · Brand (NDA)

PHOSLYRA

CALCIUM ACETATE

Brand (NDA)NDA 022581DISCN FRESENIUS MEDCL CARE

Apr 18, 2011

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 18, 2011
15 yr 5 mo ago
Today
Patent 8592480 expires
Listed method-of-use patent (U-1469) expiration.
Jul 20, 2027
in 1 yr 1 mo
Patent 9089528 expires
Listed method-of-use patent (U-1469) expiration.
Jul 20, 2027
in 1 yr 1 mo
Patent 8591938 expires
Listed drug product patent expiration.
Feb 23, 2030
in 3 yr 9 mo

Active ingredient

CALCIUM ACETATE

Strength

667MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 022581

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
8592480	Jul 20, 2027	in 1 yr 1 mo	U-1469
9089528	Jul 20, 2027	in 1 yr 1 mo	U-1469
8591938	Feb 23, 2030	in 3 yr 9 mo	ProductU-1469