FDA Orange Book · active-ingredient family
Olopatadine hydrochloride
Olopatadine hydrochloride is approved as 4 brand and 29 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:PATADAY ONCE DAILY RELIEF · NDA 206276
4
Brand (NDA)
29
Generics (ANDA)
2
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution/drops, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PATADAY ONCE DAILY RELIEFRLD | ALCON LABS INC | NDA 206276 | — | Jan 30, 2015 | |
| PATANASERLD | NOVARTIS | NDA 021861 | — | Apr 15, 2008 | |
| PATADAY ONCE DAILY RELIEFRLD | ALCON LABS INC | NDA 021545 | — | Dec 22, 2004 | |
| PATADAY TWICE DAILY RELIEFRLD | ALCON LABS INC | NDA 020688 | — | Dec 18, 1996 |
Generic (ANDA) products (29)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLOPATADINE HYDROCHLORIDE | GLAND | ANDA 213514 | — | Jan 06, 2026 | |
| OLOPATADINE HYDROCHLORIDE | FDC LTD | ANDA 217051 | — | Jul 14, 2025 | |
| OLOPATADINE HYDROCHLORIDE | GLENMARK PHARMS | ANDA 219557 | — | Feb 28, 2025 | |
| OLOPATADINE HYDROCHLORIDE | SOMERSET | ANDA 215006 | — | Dec 18, 2024 | |
| OLOPATADINE HYDROCHLORIDE | HIKMA | ANDA 213757 | — | Aug 19, 2020 | |
| OLOPATADINE HYDROCHLORIDE | RISING | ANDA 204620 | — | Jun 16, 2020 | |
| OLOPATADINE HYDROCHLORIDE | GLAND | ANDA 209752 | — | May 20, 2020 | |
| OLOPATADINE HYDROCHLORIDE | FLORIDA | ANDA 208637 | — | Feb 19, 2020 | |
| OLOPATADINE HYDROCHLORIDE | AMNEAL | ANDA 210901 | AB | Jan 28, 2020 | |
| OLOPATADINE HYDROCHLORIDE | FDC LTD | ANDA 209282 | — | Sep 26, 2019 | |
| OLOPATADINE HYDROCHLORIDE | GLAND | ANDA 209619 | — | Aug 02, 2019 | |
| OLOPATADINE HYDROCHLORIDE | ALEMBIC | ANDA 209420 | — | Apr 29, 2019 | |
| OLOPATADINE HYDROCHLORIDE | EUGIA PHARMA | ANDA 209995 | — | Apr 04, 2019 | |
| OLOPATADINE HYDROCHLORIDE | ALEMBIC | ANDA 209919 | — | Dec 07, 2018 | |
| OLOPATADINE HYDROCHLORIDE | RISING | ANDA 204392 | — | Mar 21, 2018 | |
| OLOPATADINE HYDROCHLORIDE | APOTEX | ANDA 090918 | — | Dec 05, 2017 | |
| OLOPATADINE HYDROCHLORIDE | BAUSCH AND LOMB INC | ANDA 206087 | — | Dec 05, 2017 | |
| OLOPATADINE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 204723 | — | Dec 05, 2017 | |
| OLOPATADINE HYDROCHLORIDE | BAUSCH AND LOMB INC | ANDA 206046 | — | Jul 26, 2017 | |
| OLOPATADINE HYDROCHLORIDE | GLENMARK PHARMS | ANDA 200810 | — | Jun 28, 2017 | |
| OLOPATADINE HYDROCHLORIDE | PADAGIS ISRAEL | ANDA 202853 | AB | Jan 31, 2017 | |
| OLOPATADINE HYDROCHLORIDE | SCIEGEN PHARMS | ANDA 204532 | — | Jan 10, 2017 | |
| OLOPATADINE HYDROCHLORIDE | EUGIA PHARMA | ANDA 204812 | — | Dec 18, 2015 | |
| OLOPATADINE HYDROCHLORIDE | APOTEX | ANDA 078350 | — | Dec 07, 2015 | |
| OLOPATADINE HYDROCHLORIDE | SOMERSET THERAPS LLC | ANDA 206306 | — | Dec 07, 2015 | |
| OLOPATADINE HYDROCHLORIDE | USV | ANDA 203152 | — | Dec 07, 2015 | |
| OLOPATADINE HYDROCHLORIDE | ZAMBON SPA | ANDA 204706 | — | Dec 07, 2015 | |
| OLOPATADINE HYDROCHLORIDE | BARR LABS INC | ANDA 090848 | — | Jul 13, 2015 | |
| OLOPATADINE HYDROCHLORIDE | APOTEX INC | ANDA 091572 | AB | Oct 08, 2014 |
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8791154 | May 19, 2032 | in 6 yr | ProductU-1680 |
| 9533053 | May 19, 2032 | in 6 yr | Product |
Olopatadine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
