FDA Orange Book · active-ingredient family
Bupropion hydrochloride; naltrexone hydrochloride
Bupropion hydrochloride; naltrexone hydrochloride is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:CONTRAVE · NDA 200063
1
Brand (NDA)
0
Generics (ANDA)
18
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CONTRAVERLD | NALPROPION | NDA 200063 | — | Sep 10, 2014 |
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9107837 | Jun 04, 2027 | in 1 yr | U-1639 |
| 8722085 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 9125868 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 10307376 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 12048769 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 8318788 | Nov 08, 2027 | in 1 yr 5 mo | U-1584 |
| 8088786 | Feb 03, 2029 | in 2 yr 8 mo | Product |
| 11324741 | May 29, 2029 | in 3 yr | U-1583 |
| 8916195 | Feb 02, 2030 | in 3 yr 8 mo | U-1639 |
| 11033543 | Jan 10, 2031 | in 4 yr 8 mo | U-1583 |
| 9248123 | Jan 13, 2032 | in 5 yr 8 mo | U-1808 |
| 11139056 | Jun 05, 2033 | in 7 yr 1 mo | U-1583 |
| 10403170 | Jun 05, 2033 | in 7 yr 1 mo | U-1583 |
| 9633575 | Jun 25, 2033 | in 7 yr 1 mo | U-1583 |
| 10231964 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
| 11998542 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
| 10835527 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
| 10828294 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
Bupropion hydrochloride; naltrexone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
