FDA Orange Book · active-ingredient family
Calcium acetate
Calcium acetate: 3 brands, 15 generics; first approved Dec 10, 1990; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 15 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
15
Listed patents
3
Next patent expiry
Jul 20, 2027
in 11 mo
Brand (NDA) products
Originator applications
- PHOSLYRARLDFRESENIUS MEDCL CARENDA 0225812011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG/5ML SOLUTION ORAL Discontinued — - FRESENIUS MEDCL CARENDA 02116020013 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 333.5MG CAPSULE ORAL Discontinued — 667MG CAPSULE ORAL Discontinued — 667MG CAPSULE ORAL Discontinued — - PHOSLORLDFRESENIUS MEDCL CARENDA 0199761990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Discontinued —
Generic (ANDA) products (15)
Abbreviated applications
- CALCIUM ACETATESQUARE PHARMSANDA 2172052023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATESUVEN PHARMSANDA 2110382020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATELOTUS PHARM CO LTDANDA 2032982016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Discontinued — - CALCIUM ACETATEMPP PHARMAANDA 2031792015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATELUPINANDA 2021272015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Discontinued — - CALCIUM ACETATEHERITAGE PHARMS INCANDA 2023152015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATEHERITAGE PHARMS INCANDA 2028852015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Rx AB - CALCIUM ACETATEAMNEAL PHARMSANDA 2016582014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Discontinued — - CALCIUM ACETATERSINVAGEN PHARMSANDA 2031352013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATERSCHARTWELL MOLECULARANDA 2024202013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Rx AB - CALCIUM ACETATECHARTWELL RXANDA 0913122012
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATEPADAGIS USANDA 0915612011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Discontinued — - CYPRESS PHARMANDA 0785022008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Discontinued — - CALCIUM ACETATEHIKMAANDA 0777282008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG CAPSULE ORAL Rx AB - CALCIUM ACETATEHIKMAANDA 0776932008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 667MG TABLET ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8592480 | in 11 mo | U-1469 | |
| 9089528 | in 11 mo | U-1469 | |
| 8591938 | in 3 yr 7 mo | ProductU-1469 |
Approval history
FDA approval span
First approval
36 yr 2 mo ago
Most recent approval
3 yr 6 mo ago
Approvals span 1990–2023 across 18 FDA applications.
Brand (NDA) 317%
Generic (ANDA) 1583%
Calcium acetate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
