FDA Orange Book · active-ingredient family
Colesevelam hydrochloride
Colesevelam hydrochloride is approved as 4 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:WELCHOL · NDA 210895
4
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · bar, chewable, capsule, for suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| WELCHOLRLD | COSETTE | NDA 210895 | — | Apr 03, 2019 | |
| WELCHOLRLD×2 | COSETTE | NDA 022362 | — | Oct 02, 2009 | |
| WELCHOLRLD | COSETTE | NDA 021176 | AB | May 26, 2000 | |
| WELCHOL | COSETTE | NDA 021141 | — | May 26, 2000 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | MACLEODS PHARMS LTD | ANDA 204893 | — | Apr 18, 2025 | |
| COLESEVELAM HYDROCHLORIDE | IMPAX | ANDA 212886 | — | Jan 18, 2023 | |
| COLESEVELAM HYDROCHLORIDE | UNITED RES LABS | ANDA 213456 | — | Jan 21, 2022 | |
| COLESEVELAM HYDROCHLORIDE | BEIJING TIDE PHARM | ANDA 206036 | AB | Oct 14, 2021 | |
| COLESEVELAM HYDROCHLORIDE | CHARTWELL RX | ANDA 201354 | — | Dec 17, 2020 | |
| COLESEVELAM HYDROCHLORIDE | INVENTIA | ANDA 212050 | AB | Dec 04, 2020 | |
| COLESEVELAM HYDROCHLORIDE | WATSON LABS INC | ANDA 200830 | — | Sep 02, 2020 | |
| COLESEVELAM HYDROCHLORIDE×2 | WATSON LABS INC | ANDA 202178 | — | Sep 01, 2020 | |
| COLESEVELAM HYDROCHLORIDE | ZHEJIANG JINGXIN | ANDA 209946 | AB | Jul 15, 2020 | |
| COLESEVELAM HYDROCHLORIDE | INVAGEN PHARMS | ANDA 212602 | — | Apr 20, 2020 | |
| COLESEVELAM HYDROCHLORIDE | ZYDUS PHARMS | ANDA 207765 | AB | Oct 07, 2019 | |
| COLESEVELAM HYDROCHLORIDE | BIONPHARMA | ANDA 208670 | AB | Sep 13, 2019 | |
| COLESEVELAM HYDROCHLORIDE | ALKEM LABS LTD | ANDA 210316 | AB | May 06, 2019 | |
| COLESEVELAM HYDROCHLORIDE | ALKEM LABS LTD | ANDA 209038 | AB | Oct 05, 2018 | |
| COLESEVELAM HYDROCHLORIDE | DR REDDYS | ANDA 210889 | AB | Oct 05, 2018 | |
| COLESEVELAM HYDROCHLORIDE×2 | GLENMARK PHARMS LTD | ANDA 202190 | — | Jul 16, 2018 | |
| COLESEVELAM HYDROCHLORIDE | GLENMARK PHARMS LTD | ANDA 203480 | AB | May 18, 2018 | |
| COLESEVELAM HYDROCHLORIDE | IMPAX LABS INC | ANDA 091600 | AB | May 16, 2018 |
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.
Colesevelam hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
