Orange Book product · Brand (NDA)
CONTRAVE
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
At a glance
Sep 10, 2014
Approved
Brand (NDA)
Application
Not listed
TE code
18
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 10, 2014
11 yr 11 mo ago
Today
Patent 9107837 expires
Listed method-of-use patent (U-1639) expiration.
Jun 04, 2027
in 1 yr
Patent 10307376 expires
Listed method-of-use patent (U-1585) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 12048769 expires
Listed method-of-use patent (U-1585) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 8318788 expires
Listed method-of-use patent (U-1584) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 8722085 expires
Listed method-of-use patent (U-1585) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 9125868 expires
Listed method-of-use patent (U-1585) expiration.
Nov 08, 2027
in 1 yr 5 mo
Patent 8088786 expires
Listed drug product patent expiration.
Feb 03, 2029
in 2 yr 8 mo
Patent 11324741 expires
Listed method-of-use patent (U-1583) expiration.
May 29, 2029
in 3 yr
Patent 8916195 expires
Listed method-of-use patent (U-1639) expiration.
Feb 02, 2030
in 3 yr 8 mo
Patent 11033543 expires
Listed method-of-use patent (U-1583) expiration.
Jan 10, 2031
in 4 yr 8 mo
Patent 9248123 expires
Listed method-of-use patent (U-1808) expiration.
Jan 13, 2032
in 5 yr 8 mo
Patent 10403170 expires
Listed method-of-use patent (U-1583) expiration.
Jun 05, 2033
in 7 yr 1 mo
Patent 11139056 expires
Listed method-of-use patent (U-1583) expiration.
Jun 05, 2033
in 7 yr 1 mo
Patent 9633575 expires
Listed method-of-use patent (U-1583) expiration.
Jun 25, 2033
in 7 yr 1 mo
Patent 10231964 expires
Listed method-of-use patent (U-1583) expiration.
Jul 02, 2034
in 8 yr 2 mo
Patent 10828294 expires
Listed method-of-use patent (U-1583) expiration.
Jul 02, 2034
in 8 yr 2 mo
Patent 10835527 expires
Listed method-of-use patent (U-1583) expiration.
Jul 02, 2034
in 8 yr 2 mo
Patent 11998542 expires
Listed method-of-use patent (U-1583) expiration.
Jul 02, 2034
in 8 yr 2 mo
Pharmaceutical detail
Active ingredient
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Strength
90MG;8MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 200063
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (18)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9107837 | Jun 04, 2027 | in 1 yr | U-1639 |
| 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 |
| 8722085 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 9125868 | Nov 08, 2027 | in 1 yr 5 mo | U-1585 |
| 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 |
| 10403170 | Jun 05, 2033 | in 7 yr 1 mo | U-1583 |
| 11139056 | 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 |
| 10828294 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
| 10835527 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
| 11998542 | Jul 02, 2034 | in 8 yr 2 mo | U-1583 |
