FDA Orange Book
Generic for Fosrenol
Fosrenol contains lanthanum carbonate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Fosrenol is lanthanum carbonate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 6 Fosrenol products the Orange Book lists.
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Fosrenol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, oral | EQ 1GM BASE | Marketed (Rx) | None | 0 | None |
| powder, oral | EQ 750MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, chewable, oral | EQ 1GM BASE | Marketed (Rx) | AB | 4 | AB |
| tablet, chewable, oral | EQ 250MG BASE | Discontinued | None | 0 | None |
| tablet, chewable, oral | EQ 500MG BASE | Marketed (Rx) | AB | 4 | AB |
| tablet, chewable, oral | EQ 750MG BASE | Marketed (Rx) | AB | 4 | AB |
NDA 204734, 021468, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic lanthanum carbonate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| NATCO PHARMA LTD | 090978 | AB (A-rated, therapeutically equivalent) | August 11, 2017 | EQ 1GM BASE, EQ 500MG BASE, EQ 750MG BASE |
| INVAGEN PHARMACEUTICALS INC | 206868 | AB (A-rated, therapeutically equivalent) | January 24, 2022 | EQ 1GM BASE, EQ 500MG BASE, EQ 750MG BASE |
| BARR LABORATORIES INC A WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC | 090977 | AB (A-rated, therapeutically equivalent) | January 27, 2022 | EQ 1GM BASE, EQ 500MG BASE, EQ 750MG BASE |
| ALKEM LABORATORIES LTD | 202329 | AB (A-rated, therapeutically equivalent) | March 13, 2025 | EQ 1GM BASE, EQ 500MG BASE, EQ 750MG BASE |
Fosrenol patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8980327 | December 1, 2030 | Drug product | None | 204734 |
| 9023397 | December 1, 2030 | Drug product | None | 204734 |
Fosrenol NDC codes
Questions
Is there a generic for Fosrenol?
Yes. The generic name for Fosrenol is lanthanum carbonate. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 3 of the 6 Fosrenol products the Orange Book lists.
What is the generic name for Fosrenol?
The active ingredient in Fosrenol is lanthanum carbonate, per the FDA Orange Book.
When does the Fosrenol patent expire?
The last patent listed for Fosrenol in the Orange Book expires December 1, 2030. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.