FDA Orange Book · active-ingredient family
Olmesartan medoxomil
Olmesartan medoxomil is approved as 1 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BENICAR · NDA 021286
1
Brand (NDA)
25
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENICARRLD×3 | COSETTE | NDA 021286 | AB | Apr 25, 2002 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLMESARTAN MEDOXOMIL×3 | CADILA PHARMS LTD | ANDA 210682 | AB | Nov 08, 2024 | |
| OLMESARTAN MEDOXOMIL×3 | HETERO LABS LTD V | ANDA 205499 | AB | Oct 31, 2024 | |
| OLMESARTAN MEDOXOMIL×3 | CHARTWELL RX | ANDA 206227 | AB | Jan 25, 2024 | |
| OLMESARTAN MEDOXOMIL×3 | AMNEAL | ANDA 207480 | — | Jul 11, 2023 | |
| OLMESARTAN MEDOXOMIL×3 | MSN | ANDA 217399 | AB | Jan 18, 2023 | |
| OLMESARTAN MEDOXOMIL×3 | PRINSTON INC | ANDA 206720 | AB | Dec 02, 2022 | |
| OLMESARTAN MEDOXOMIL×3 | INVENTIA | ANDA 208659 | AB | May 18, 2020 | |
| OLMESARTAN MEDOXOMIL×3 | SANDOZ | ANDA 090237 | — | Apr 13, 2020 | |
| OLMESARTAN MEDOXOMIL×3 | MICRO LABS | ANDA 206372 | AB | Sep 17, 2019 | |
| OLMESARTAN MEDOXOMIL×3 | UMEDICA | ANDA 207135 | AB | Jul 18, 2019 | |
| OLMESARTAN MEDOXOMIL×3 | SUNSHINE | ANDA 211049 | AB | Feb 22, 2019 | |
| OLMESARTAN MEDOXOMIL×3 | QILU | ANDA 210552 | AB | Jan 10, 2019 | |
| OLMESARTAN MEDOXOMIL×3 | SCIEGEN PHARMS | ANDA 208130 | AB | Jun 29, 2018 | |
| OLMESARTAN MEDOXOMIL×3 | GLENMARK PHARMS LTD | ANDA 203281 | AB | May 25, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | LUPIN | ANDA 206631 | — | Apr 27, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | ACCORD HLTHCARE | ANDA 207662 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | ALEMBIC | ANDA 203012 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | ALKEM LABS LTD | ANDA 206763 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | AUROBINDO PHARMA | ANDA 204798 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | JUBILANT GENERICS | ANDA 205482 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | MACLEODS PHARMS LTD | ANDA 204814 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | TEVA PHARMS USA | ANDA 091079 | — | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | TORRENT | ANDA 202375 | — | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | ZYDUS PHARMS | ANDA 205192 | AB | Apr 24, 2017 | |
| OLMESARTAN MEDOXOMIL×3 | RISING | ANDA 078276 | — | Oct 26, 2016 |
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.
Olmesartan medoxomil — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
