FDA Orange Book · active-ingredient family
Olanzapine
Olanzapine is approved as 3 brand and 46 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ZYPREXA · NDA 021253
3
Brand (NDA)
46
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · powder, tablet, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYPREXARLD | CHEPLAPHARM | NDA 021253 | AP | Mar 29, 2004 | |
| ZYPREXA ZYDISRLD×4 | CHEPLAPHARM | NDA 021086 | AB | Apr 06, 2000 | |
| ZYPREXARLD×6 | CHEPLAPHARM | NDA 020592 | AB | Sep 30, 1996 |
Generic (ANDA) products (46)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OLANZAPINE | ANTHEA PHARMA | ANDA 220323 | AP | Mar 05, 2026 | |
| OLANZAPINE | OMNIVIUM PHARMS | ANDA 219048 | AP | Jan 23, 2026 | |
| OLANZAPINE | UBI | ANDA 211072 | AP | Jun 11, 2025 | |
| OLANZAPINE | QILU | ANDA 218116 | AP | May 16, 2025 | |
| OLANZAPINE | ASPIRO | ANDA 217466 | AP | Mar 22, 2023 | |
| OLANZAPINE×4 | ZYDUS PHARMS | ANDA 202889 | — | Mar 09, 2023 | |
| OLANZAPINE×6 | CADILA PHARMS LTD | ANDA 210022 | AB | Feb 24, 2023 | |
| OLANZAPINE×4 | HISUN PHARM HANGZHOU | ANDA 206892 | AB | Dec 31, 2020 | |
| OLANZAPINE×6 | HISUN PHARM HANGZHOU | ANDA 206924 | — | Dec 31, 2020 | |
| OLANZAPINE | EUGIA PHARMA | ANDA 210968 | AP | Oct 22, 2020 | |
| OLANZAPINE×6 | INDOCO | ANDA 206155 | — | Jul 31, 2020 | |
| OLANZAPINE×6 | SUNSHINE | ANDA 206238 | AB | Nov 19, 2018 | |
| OLANZAPINE×3 | JIANGSU HANSOH PHARM | ANDA 209399 | — | Sep 24, 2018 | |
| OLANZAPINE×6 | ZYDUS PHARMS | ANDA 090459 | AB | Jul 16, 2018 | |
| OLANZAPINE×4 | HEC PHARM | ANDA 208146 | AB | Jul 02, 2018 | |
| OLANZAPINE×6 | HIKMA | ANDA 204866 | — | Jun 16, 2017 | |
| OLANZAPINE×4 | AJANTA PHARMA LTD | ANDA 204320 | — | May 30, 2017 | |
| OLANZAPINE×6 | AJANTA PHARMA LTD | ANDA 206711 | — | Aug 30, 2016 | |
| OLANZAPINE×4 | CHARTWELL MOLECULAR | ANDA 203456 | AB | Mar 16, 2016 | |
| OLANZAPINE×6 | CHARTWELL MOLECULAR | ANDA 203333 | AB | Mar 15, 2016 | |
| OLANZAPINE×6 | QILU | ANDA 204319 | AB | Jan 27, 2016 | |
| OLANZAPINE×6 | ALKEM LABS LTD | ANDA 202295 | AB | Oct 20, 2015 | |
| OLANZAPINE | IVAX PHARMS INC | ANDA 077301 | — | Apr 29, 2015 | |
| OLANZAPINE×4 | ORBION PHARMS | ANDA 202937 | AB | Mar 02, 2015 | |
| OLANZAPINE×4 | MACLEODS PHARMS LTD | ANDA 203044 | AB | Feb 20, 2015 | |
| OLANZAPINE×6 | MACLEODS PHARMS LTD | ANDA 202862 | AB | Aug 15, 2014 | |
| OLANZAPINE×4 | AUROBINDO PHARMA LTD | ANDA 203708 | AB | May 15, 2014 | |
| OLANZAPINE×4 | PHARMOBEDIENT | ANDA 202285 | AB | May 12, 2014 | |
| OLANZAPINE×4 | JUBILANT GENERICS | ANDA 200221 | AB | Sep 12, 2012 | |
| OLANZAPINE×6 | APOTEX INC | ANDA 090798 | AB | Apr 23, 2012 | |
| OLANZAPINE×6 | AUROBINDO PHARMA LTD | ANDA 202050 | AB | Apr 23, 2012 | |
| OLANZAPINE×4 | DR REDDYS LABS LTD | ANDA 076255 | AB | Apr 23, 2012 | |
| OLANZAPINE×2 | DR REDDYS LABS LTD | ANDA 076133 | AB | Apr 23, 2012 | |
| OLANZAPINE×6 | NATCO PHARMA | ANDA 076866 | — | Apr 23, 2012 | |
| OLANZAPINE×6 | ORBION PHARMS | ANDA 202287 | AB | Apr 23, 2012 | |
| OLANZAPINE×6 | SUN PHARM INDS | ANDA 091038 | — | Apr 23, 2012 | |
| OLANZAPINE×6 | TORRENT PHARMS LTD | ANDA 091434 | AB | Apr 23, 2012 | |
| OLANZAPINE | AM REGENT | ANDA 201741 | AP | Mar 20, 2012 | |
| OLANZAPINE×4 | SUN PHARM INDS | ANDA 090881 | — | Feb 28, 2012 | |
| OLANZAPINE×4 | BARR LABS INC | ANDA 077243 | AB | Jan 30, 2012 | |
| OLANZAPINE×4 | TORRENT | ANDA 091415 | AB | Oct 25, 2011 | |
| OLANZAPINE | SANDOZ INC | ANDA 201588 | AP | Oct 24, 2011 | |
| OLANZAPINE×4 | APOTEX INC | ANDA 091265 | AB | Oct 24, 2011 | |
| OLANZAPINE×4 | DR REDDYS LABS LTD | ANDA 076534 | AB | Oct 24, 2011 | |
| OLANZAPINE×4 | STRIDES PHARMA INTL | ANDA 078109 | AB | Oct 24, 2011 | |
| OLANZAPINE×5 | TEVA PHARMS | ANDA 076000 | — | Oct 24, 2011 |
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.
Olanzapine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
