FDA Orange Book
Generic for Renvela
Renvela contains sevelamer 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 Renvela is sevelamer carbonate. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Renvela products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 2.4GM/PACKET | Discontinued | None | 6 | AB |
| for suspension, oral | 800MG/PACKET | Discontinued | None | 7 | AB |
| tablet, oral | 800MG | Discontinued | None | 11 | AB |
NDA 022318, 022127, 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 carbonate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 207624 | AB (A-rated, therapeutically equivalent) | June 13, 2017 | 2.4GM/PACKET, 800MG/PACKET |
| AUROBINDO PHARMA LTD | 207179 | AB (A-rated, therapeutically equivalent) | July 17, 2017 | 800MG |
| DR REDDYS LABORATORIES LTD | 206094 | AB (A-rated, therapeutically equivalent) | September 29, 2017 | 800MG |
| INVAGEN PHARMACEUTICALS INC | 203860 | AB (A-rated, therapeutically equivalent) | October 26, 2017 | 800MG |
| AMNEAL PHARMACEUTICALS CO GMBH | 207288 | AB (A-rated, therapeutically equivalent) | November 28, 2017 | 800MG |
| QUAGEN PHARMACEUTICALS LLC | 200959 | AB (A-rated, therapeutically equivalent) | March 20, 2018 | 800MG |
| DR REDDYS LABORATORIES LTD | 210464 | AB (A-rated, therapeutically equivalent) | October 25, 2018 | 2.4GM/PACKET, 800MG/PACKET |
| RISING PHARMA HOLDINGS INC | 204451 | AB (A-rated, therapeutically equivalent) | November 29, 2018 | 800MG |
| ZYDUS PHARMACEUTICALS USA INC | 207759 | AB (A-rated, therapeutically equivalent) | August 11, 2020 | 800MG |
| IMPAX LABORATORIES LLC | 211316 | AB (A-rated, therapeutically equivalent) | November 20, 2020 | 2.4GM/PACKET, 800MG/PACKET |
| BIONPHARMA INC | 209374 | AB (A-rated, therapeutically equivalent) | May 17, 2021 | 800MG/PACKET |
| CHARTWELL RX SCIENCES LLC | 217319 | AB (A-rated, therapeutically equivalent) | March 2, 2023 | 2.4GM/PACKET, 800MG/PACKET |
| MACLEODS PHARMACEUTICALS LTD | 206100 | AB (A-rated, therapeutically equivalent) | April 19, 2023 | 800MG |
| STRIDES PHARMA INTERNATIONAL AG | 211917 | AB (A-rated, therapeutically equivalent) | September 8, 2023 | 2.4GM/PACKET, 800MG/PACKET |
| MACLEODS PHARMACEUTICALS LTD | 207291 | AB (A-rated, therapeutically equivalent) | April 25, 2024 | 2.4GM/PACKET, 800MG/PACKET |
| STRIDES PHARMA GLOBAL PTE LTD | 211915 | AB (A-rated, therapeutically equivalent) | May 9, 2024 | 800MG |
| SHANDONG XINHUA PHARMACEUTICAL CO LTD | 215998 | AB (A-rated, therapeutically equivalent) | October 24, 2024 | 800MG |
| NAVINTA LLC | 219931 | AB (A-rated, therapeutically equivalent) | October 27, 2025 | 800MG |
Renvela patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9095509 | December 6, 2030 | Drug product | None | 022318 |
Renvela NDC codes
Questions
Is there a generic for Renvela?
Yes. The generic name for Renvela is sevelamer carbonate. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Renvela?
The active ingredient in Renvela is sevelamer carbonate, per the FDA Orange Book.
When does the Renvela patent expire?
The last patent listed for Renvela in the Orange Book expires December 6, 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.
More on Renvela and Sevelamer Carbonate
- What is Renvela used for?FDA label uses
- Is Renvela a controlled substance?Federal schedule
- What is Sevelamer Carbonate used for?FDA label uses
- Is Sevelamer Carbonate a controlled substance?Federal schedule
- Phosphate Binders listFDA drug class
- NDC 58468-0131Renvela NDC record
- NDC 58468-0132Renvela NDC record
- NDC 58468-0133Renvela NDC record