FDA Orange Book · active-ingredient family
Lanthanum carbonate
Lanthanum carbonate: 2 brands, 4 generics; first approved Oct 26, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
4
Listed patents
2
Next patent expiry
Dec 01, 2030
in 4 yr 2 mo
Brand (NDA) products
Originator applications
- TAKEDA PHARMS USANDA 20473420142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 750MG BASE POWDER ORAL Rx — EQ 1GM BASE POWDER ORAL Rx — - TAKEDA PHARMS USANDA 02146820054 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 250MG BASE TABLET, CHEWABLE ORAL Discontinued — EQ 500MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 750MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 1GM BASE TABLET, CHEWABLE ORAL Rx AB
Generic (ANDA) products (4)
Abbreviated applications
- LANTHANUM CARBONATEALKEM LABS LTDANDA 20232920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 750MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 1GM BASE TABLET, CHEWABLE ORAL Rx AB - LANTHANUM CARBONATEBARRANDA 09097720223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 750MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 1GM BASE TABLET, CHEWABLE ORAL Rx AB - LANTHANUM CARBONATEINVAGEN PHARMSANDA 20686820223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 750MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 1GM BASE TABLET, CHEWABLE ORAL Rx AB - LANTHANUM CARBONATENATCO PHARMA LTDANDA 09097820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 500MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 750MG BASE TABLET, CHEWABLE ORAL Rx AB EQ 1GM BASE TABLET, CHEWABLE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8980327 | in 4 yr 2 mo | Product | |
| 9023397 | in 4 yr 2 mo | Product |
Approval history
FDA approval span
First approval
22 yr 3 mo ago
Most recent approval
1 yr 7 mo ago
Approvals span 2004–2025 across 6 FDA applications.
Brand (NDA) 233%
Generic (ANDA) 467%
Lanthanum carbonate: 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.
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