FDA Orange Book · active-ingredient family
Lanthanum carbonate
Lanthanum carbonate is approved as 2 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FOSRENOL · NDA 204734
2
Brand (NDA)
4
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOSRENOLRLD×2 | TAKEDA PHARMS USA | NDA 204734 | — | Sep 24, 2014 | |
| FOSRENOLRLD×4 | TAKEDA PHARMS USA | NDA 021468 | AB | Nov 23, 2005 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| LANTHANUM CARBONATE×3 | ALKEM LABS LTD | ANDA 202329 | AB | Mar 13, 2025 | |
| LANTHANUM CARBONATE×3 | BARR | ANDA 090977 | AB | Jan 27, 2022 | |
| LANTHANUM CARBONATE×3 | INVAGEN PHARMS | ANDA 206868 | AB | Jan 24, 2022 | |
| LANTHANUM CARBONATE×3 | NATCO PHARMA LTD | ANDA 090978 | AB | Aug 11, 2017 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8980327 | Dec 01, 2030 | in 4 yr 6 mo | Product |
| 9023397 | Dec 01, 2030 | in 4 yr 6 mo | Product |
Lanthanum carbonate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
