FDA Orange Book · active-ingredient family
Sevelamer hydrochloride
Sevelamer hydrochloride is approved as 2 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:RENAGEL · NDA 021179
2
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RENAGELRLD×2 | GENZYME | NDA 021179 | AB | Jul 12, 2000 | |
| RENAGEL | GENZYME | NDA 020926 | — | Oct 30, 1998 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SEVELAMER HYDROCHLORIDE | NAVINTA LLC | ANDA 218966 | AB | Feb 03, 2025 | |
| SEVELAMER HYDROCHLORIDE×2 | AUROBINDO PHARMA LTD | ANDA 212599 | BX | Jul 11, 2023 | |
| SEVELAMER HYDROCHLORIDE×2 | MACLEODS PHARMS LTD | ANDA 206883 | AB | May 26, 2023 | |
| SEVELAMER HYDROCHLORIDE×2 | LUPIN | ANDA 213145 | AB | Jun 16, 2021 | |
| SEVELAMER HYDROCHLORIDE×2 | RISING | ANDA 201068 | — | Dec 14, 2020 | |
| SEVELAMER HYDROCHLORIDE×2 | GLENMARK PHARMS LTD | ANDA 204724 | AB | Feb 08, 2019 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Sevelamer hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
