FDA Orange Book · active-ingredient family
Erlotinib hydrochloride
Erlotinib hydrochloride is approved as 1 brand and 13 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:TARCEVA · NDA 021743
1
Brand (NDA)
13
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TARCEVARLD×3 | OSI PHARMS | NDA 021743 | — | Nov 18, 2004 |
Generic (ANDA) products (13)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ERLOTINIB HYDROCHLORIDE×2 | CHARTWELL RX | ANDA 203843 | AB | Sep 13, 2024 | |
| ERLOTINIB HYDROCHLORIDE×3 | HETERO LABS LTD V | ANDA 209267 | AB | May 24, 2024 | |
| ERLOTINIB HYDROCHLORIDE×3 | EUGIA PHARMA | ANDA 216342 | — | Jun 22, 2022 | |
| ERLOTINIB HYDROCHLORIDE×3 | ALEMBIC | ANDA 214719 | AB | Jul 08, 2021 | |
| ERLOTINIB HYDROCHLORIDE×3 | MSN | ANDA 214366 | AB | May 10, 2021 | |
| ERLOTINIB HYDROCHLORIDE×3 | TEVA PHARMS USA INC | ANDA 091059 | AB | Nov 09, 2020 | |
| ERLOTINIB HYDROCHLORIDE×3 | ACCORD HLTHCARE | ANDA 211083 | — | Jul 02, 2020 | |
| ERLOTINIB HYDROCHLORIDE×3 | ZYDUS PHARMS | ANDA 213065 | AB | Apr 16, 2020 | |
| ERLOTINIB HYDROCHLORIDE×3 | APOTEX | ANDA 208396 | — | Nov 05, 2019 | |
| ERLOTINIB HYDROCHLORIDE×3 | NATCO PHARMA LTD | ANDA 208488 | — | Nov 05, 2019 | |
| ERLOTINIB HYDROCHLORIDE×3 | SHILPA | ANDA 211960 | AB | Nov 05, 2019 | |
| ERLOTINIB HYDROCHLORIDE×3 | SUN PHARM | ANDA 210300 | — | Nov 05, 2019 | |
| ERLOTINIB HYDROCHLORIDE×3 | RISING | ANDA 091002 | AB | Jun 11, 2014 |
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.
Erlotinib hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
