FDA Orange Book · active-ingredient family
Bupropion hydrochloride; dextromethorphan hydrobromide
Bupropion hydrochloride; dextromethorphan hydrobromide is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AUVELITY · NDA 215430
1
Brand (NDA)
0
Generics (ANDA)
145
Listed patents
2
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AUVELITYRLD×2 | AXSOME | NDA 215430 | — | Apr 30, 2026 |
Marketing exclusivity (2)
- I-913New indication exclusivity (3 years)
Apr 30, 2029
in 2 yr 11 mo
- I-913New indication exclusivity (3 years)
Apr 30, 2029
in 2 yr 11 mo
Listed patents (145)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8569328 | Jul 18, 2032 | in 6 yr 2 mo | ProductU-4516 |
| 9968568 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9168234 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 10080727 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 11590124 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 11291638 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11007189 | Nov 05, 2034 | in 8 yr 6 mo | U-4516 |
| 9700528 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11253492 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 9861595 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9700553 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9486450 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9370513 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 9375429 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9314462 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9457023 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11207281 | Nov 05, 2034 | in 8 yr 6 mo | U-4537 |
| 10092560 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 10780066 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9198905 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 9205083 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 9707191 | Nov 05, 2034 | in 8 yr 6 mo | U-4522 |
| 10058518 | Nov 05, 2034 | in 8 yr 6 mo | U-4522 |
| 11571417 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 10105361 | Nov 05, 2034 | in 8 yr 6 mo | U-4522 |
| 10251879 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11285146 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11273134 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11273133 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 11298352 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11344544 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11426370 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 11382874 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11234946 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 9763932 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11617747 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 11285118 | Nov 05, 2034 | in 8 yr 6 mo | U-4526 |
| 11419867 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11291665 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9421176 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9408815 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9238032 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 9474731 | Nov 05, 2034 | in 8 yr 6 mo | U-4520 |
| 9457025 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 9867819 | Nov 05, 2034 | in 8 yr 6 mo | U-4517 |
| 11524008 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11524007 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11517542 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11517543 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11510918 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11364233 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 9278095 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11357744 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11311534 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10898453 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11433067 | Nov 05, 2034 | in 8 yr 6 mo | ProductU-3419 |
| 11096937 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10966941 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11298351 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11090300 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10894047 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10064857 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10786469 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10881657 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10874663 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10799497 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11058648 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10864209 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10806710 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10881624 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10786496 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11020389 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11185515 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10945973 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10596167 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11439636 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11426401 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10772850 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11253491 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10548857 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11229640 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10874665 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10933034 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10092561 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10894046 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11191739 | Nov 05, 2034 | in 8 yr 6 mo | ProductU-3419 |
| 10874664 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11197839 | Nov 05, 2034 | in 8 yr 6 mo | ProductU-3419 |
| 11147808 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11141416 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11141388 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11213521 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11129826 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11123343 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10966974 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10512643 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10463634 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10105327 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11969421 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11576909 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11123344 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11065248 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11478468 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11541048 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11541021 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11534414 | Nov 05, 2034 | in 8 yr 6 mo | ProductU-3419 |
| 11779579 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11617728 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11596627 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 11497721 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 12109178 | Nov 05, 2034 | in 8 yr 6 mo | U-3419 |
| 10780064 | Jan 07, 2040 | in 13 yr 9 mo | U-3419 |
| 10966942 | Jan 07, 2040 | in 13 yr 9 mo | U-3419 |
| 10940124 | Jan 07, 2040 | in 13 yr 9 mo | U-3419 |
| 10925842 | Jan 07, 2040 | in 13 yr 9 mo | U-3419 |
| 12576078 | Jun 05, 2040 | in 14 yr 2 mo | U-4516 |
| 12433884 | Jun 05, 2040 | in 14 yr 2 mo | U-4514 |
| 12472156 | Jun 05, 2040 | in 14 yr 2 mo | U-4516 |
| 12390428 | Dec 01, 2041 | in 15 yr 8 mo | U-3419 |
| 11896563 | Dec 01, 2041 | in 15 yr 8 mo | U-3419 |
| 12472174 | Jan 20, 2043 | in 16 yr 10 mo | U-4515 |
| 12310961 | Jan 20, 2043 | in 16 yr 10 mo | U-3419 |
| 11925636 | Jan 20, 2043 | in 16 yr 10 mo | U-3419 |
| 12357697 | Jan 20, 2043 | in 16 yr 10 mo | U-3419 |
| 11717518 | Jan 20, 2043 | in 16 yr 10 mo | U-3419 |
| 12239642 | Jan 20, 2043 | in 16 yr 10 mo | U-4515 |
| 12263161 | Jan 20, 2043 | in 16 yr 10 mo | U-4515 |
| 12564587 | Jan 20, 2043 | in 16 yr 10 mo | U-4515 |
| 12478622 | Jan 20, 2043 | in 16 yr 10 mo | U-4515 |
| 12156914 | Jan 20, 2043 | in 16 yr 10 mo | Product |
| 11730706 | Jan 23, 2043 | in 16 yr 10 mo | U-3419 |
| 11883373 | Jan 23, 2043 | in 16 yr 10 mo | U-3419 |
| 12194005 | Jan 23, 2043 | in 16 yr 10 mo | U-4523 |
| 12364674 | Jan 23, 2043 | in 16 yr 10 mo | U-4516 |
| 12036191 | Feb 15, 2043 | in 16 yr 11 mo | U-3419 |
| 11986444 | Feb 15, 2043 | in 16 yr 11 mo | U-3419 |
| 12370154 | Feb 15, 2043 | in 16 yr 11 mo | U-4518 |
| 12599576 | Feb 15, 2043 | in 16 yr 11 mo | U-4518 |
| 12146889 | Feb 23, 2043 | in 16 yr 11 mo | U-3419 |
| 11752144 | Feb 23, 2043 | in 16 yr 11 mo | U-3419 |
| 12042473 | Feb 23, 2043 | in 16 yr 11 mo | U-3419 |
| 12472155 | Feb 23, 2043 | in 16 yr 11 mo | U-4519 |
| 11839612 | Mar 02, 2043 | in 16 yr 11 mo | U-3419 |
| 11844797 | Apr 20, 2043 | in 17 yr 1 mo | U-3778 |
| 12194036 | Apr 20, 2043 | in 17 yr 1 mo | U-4521 |
Bupropion hydrochloride; dextromethorphan hydrobromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
