FDA Orange Book · active-ingredient family
Quetiapine fumarate
Quetiapine fumarate is approved as 2 brand and 38 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:SEROQUEL XR · NDA 022047
2
Brand (NDA)
38
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SEROQUEL XRRLD×5 | CHEPLAPHARM | NDA 022047 | AB | May 17, 2007 | |
| SEROQUELRLD×7 | CHEPLAPHARM | NDA 020639 | AB | Sep 26, 1997 |
Generic (ANDA) products (38)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| QUETIAPINE FUMARATE×5 | RISING | ANDA 211144 | AB | Nov 26, 2024 | |
| QUETIAPINE FUMARATE×6 | IPCA LABS LTD | ANDA 205983 | — | May 20, 2024 | |
| QUETIAPINE FUMARATE×6 | PRINSTON INC | ANDA 206954 | AB | Aug 24, 2022 | |
| QUETIAPINE FUMARATE×5 | UNICHEM | ANDA 215478 | AB | Aug 15, 2022 | |
| QUETIAPINE FUMARATE×6 | HETERO LABS LTD V | ANDA 204316 | AB | Jun 16, 2022 | |
| QUETIAPINE FUMARATE×5 | PRINSTON INC | ANDA 208781 | AB | Apr 26, 2022 | |
| QUETIAPINE FUMARATE×5 | RISING | ANDA 202228 | — | Feb 02, 2021 | |
| QUETIAPINE FUMARATE×5 | SCIEGEN PHARMS | ANDA 209635 | AB | Nov 16, 2018 | |
| QUETIAPINE FUMARATE | AMNEAL PHARMS | ANDA 211405 | — | Oct 26, 2018 | |
| QUETIAPINE FUMARATE×2 | ALIGNSCIENCE PHARMA | ANDA 209497 | AB | Sep 28, 2018 | |
| QUETIAPINE FUMARATE×4 | PH HEALTH | ANDA 090757 | — | Dec 01, 2017 | |
| QUETIAPINE FUMARATE | ACCORD HLTHCARE | ANDA 206252 | AB | Nov 29, 2017 | |
| QUETIAPINE FUMARATE×5 | AUROBINDO PHARMA | ANDA 207655 | AB | Nov 29, 2017 | |
| QUETIAPINE FUMARATE×4 | MACLEODS PHARMS LTD | ANDA 204253 | AB | Nov 29, 2017 | |
| QUETIAPINE FUMARATE×5 | NOVAST LABS | ANDA 208947 | AB | Nov 29, 2017 | |
| QUETIAPINE FUMARATE×5 | LUPIN | ANDA 204203 | AB | May 17, 2017 | |
| QUETIAPINE FUMARATE×4 | ACCORD HLTHCARE | ANDA 090681 | AB | May 09, 2017 | |
| QUETIAPINE FUMARATE×5 | PH HEALTH | ANDA 090482 | — | May 09, 2017 | |
| QUETIAPINE FUMARATE×5 | PHARMADAX | ANDA 206260 | — | May 09, 2017 | |
| QUETIAPINE FUMARATE×5 | PLATINUM | ANDA 202939 | AB | May 09, 2017 | |
| QUETIAPINE FUMARATE×6 | MACLEODS PHARMS LTD | ANDA 203359 | AB | May 17, 2016 | |
| QUETIAPINE FUMARATE×6 | UNICHEM | ANDA 202674 | AB | Mar 08, 2016 | |
| QUETIAPINE FUMARATE×6 | ALEMBIC | ANDA 203390 | — | Oct 28, 2014 | |
| QUETIAPINE FUMARATE | JUBILANT GENERICS | ANDA 203150 | — | Nov 26, 2013 | |
| QUETIAPINE FUMARATE×7 | ACTAVIS GRP PTC | ANDA 201762 | — | Feb 27, 2013 | |
| QUETIAPINE FUMARATE×7 | ALKEM LABS LTD | ANDA 201504 | AB | Feb 12, 2013 | |
| QUETIAPINE FUMARATE×7 | CHARTWELL RX | ANDA 078679 | — | Dec 14, 2012 | |
| QUETIAPINE FUMARATE×6 | ACCORD HLTHCARE | ANDA 202152 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×7 | AUROBINDO PHARMA LTD | ANDA 091388 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE | HIKMA | ANDA 090120 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×5 | HIKMA | ANDA 090749 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×6 | LUPIN LTD | ANDA 201109 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE | PHARMOBEDIENT | ANDA 090323 | — | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×7 | RISING | ANDA 077380 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×6 | SCIEGEN PHARMS | ANDA 090960 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×6 | SUN PHARM | ANDA 201190 | — | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×7 | TEVA PHARMS | ANDA 077745 | AB | Mar 27, 2012 | |
| QUETIAPINE FUMARATE×6 | TORRENT PHARMS LTD | ANDA 200363 | — | Mar 27, 2012 |
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.
Quetiapine fumarate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
