FDA Orange Book
Generic for Renagel
Renagel contains sevelamer. 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 Renagel is sevelamer. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 2 of the 3 Renagel products the Orange Book lists.
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Renagel products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 403MG | Discontinued | None | 0 | None |
| tablet, oral | 400MG | Marketed (Rx) | AB | 4 | AB, BX |
| tablet, oral | 800MG | Marketed (Rx) | AB | 5 | AB, BX |
NDA 020926, 021179, held by GENZYME CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sevelamer
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| GLENMARK PHARMACEUTICALS LTD | 204724 | AB (A-rated, therapeutically equivalent) | February 8, 2019 | 400MG, 800MG |
| LUPIN LTD | 213145 | AB (A-rated, therapeutically equivalent) | June 16, 2021 | 400MG, 800MG |
| MACLEODS PHARMACEUTICALS LTD | 206883 | AB (A-rated, therapeutically equivalent) | May 26, 2023 | 400MG, 800MG |
| AUROBINDO PHARMA LTD | 212599 | BX (B-rated, not considered equivalent) | July 11, 2023 | 400MG, 800MG |
| NAVINTA LLC | 218966 | AB (A-rated, therapeutically equivalent) | February 3, 2025 | 800MG |
Questions
Is there a generic for Renagel?
Yes. The generic name for Renagel is sevelamer. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, BX. Generics match 2 of the 3 Renagel products the Orange Book lists.
What is the generic name for Renagel?
The active ingredient in Renagel is sevelamer, per the FDA Orange Book.
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.