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FDA Orange Book · active-ingredient family

Calcium acetate

Calcium acetate is approved as 3 brand and 15 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:PHOSLYRA · NDA 022581

3

Brand (NDA)

15

Generics (ANDA)

3

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet

ProductApplicantApplicationTEApproved
PHOSLYRARLDFRESENIUS MEDCL CARENDA 022581—Apr 18, 2011
PHOSLO GELCAPSRLD×3FRESENIUS MEDCL CARENDA 021160—Apr 02, 2001
PHOSLORLDFRESENIUS MEDCL CARENDA 019976—Dec 10, 1990

Generic (ANDA) products (15)

ProductApplicantApplicationTEApproved
CALCIUM ACETATESQUARE PHARMSANDA 217205ABMar 13, 2023
CALCIUM ACETATESUVEN PHARMSANDA 211038ABFeb 21, 2020
CALCIUM ACETATELOTUS PHARM CO LTDANDA 203298—Jul 26, 2016
CALCIUM ACETATEMPP PHARMAANDA 203179ABOct 26, 2015
CALCIUM ACETATELUPINANDA 202127—Jul 09, 2015
CALCIUM ACETATEHERITAGE PHARMS INCANDA 202315ABJun 29, 2015
CALCIUM ACETATEHERITAGE PHARMS INCANDA 202885ABJan 22, 2015
CALCIUM ACETATEAMNEAL PHARMSANDA 201658—Oct 06, 2014
CALCIUM ACETATEINVAGEN PHARMSANDA 203135ABFeb 07, 2013
CALCIUM ACETATECHARTWELL MOLECULARANDA 202420ABFeb 05, 2013
CALCIUM ACETATECHARTWELL RXANDA 091312ABJun 01, 2012
CALCIUM ACETATEPADAGIS USANDA 091561—Apr 13, 2011
ELIPHOSCYPRESS PHARMANDA 078502—Nov 25, 2008
CALCIUM ACETATEHIKMAANDA 077728ABFeb 26, 2008
CALCIUM ACETATEHIKMAANDA 077693—Jan 30, 2008

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8592480Jul 20, 2027in 1 yr 1 mo
U-1469
9089528Jul 20, 2027in 1 yr 1 mo
U-1469
8591938Feb 23, 2030in 3 yr 9 mo
ProductU-1469

Calcium acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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