Orange Book product · Brand (NDA)
EMBEDA
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
At a glance
Aug 13, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 13, 2009
17 yr 1 mo ago
Today
Patent 7682633 expires
Listed method-of-use patent (U-1510) expiration.
Jun 19, 2027
in 1 yr
Patent 7682634 expires
Listed drug product patent expiration.
Jun 19, 2027
in 1 yr
Patent 8158156 expires
Listed method-of-use patent (U-1510) expiration.
Jun 19, 2027
in 1 yr
Patent 8846104 expires
Listed drug product patent expiration.
Jun 19, 2027
in 1 yr
Patent 8877247 expires
Listed drug product patent expiration.
Jun 19, 2027
in 1 yr
Patent 7815934 expires
Listed drug product patent expiration.
Dec 12, 2027
in 1 yr 6 mo
Patent 8623418 expires
Listed method-of-use patent (U-1640) expiration.
Nov 07, 2029
in 3 yr 5 mo
Pharmaceutical detail
Active ingredient
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
Strength
20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 022321
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7682633 | Jun 19, 2027 | in 1 yr | U-1510 |
| 7682634 | Jun 19, 2027 | in 1 yr | Product |
| 8158156 | Jun 19, 2027 | in 1 yr | U-1510 |
| 8846104 | Jun 19, 2027 | in 1 yr | Product |
| 8877247 | Jun 19, 2027 | in 1 yr | Product |
| 7815934 | Dec 12, 2027 | in 1 yr 6 mo | Product |
| 8623418 | Nov 07, 2029 | in 3 yr 5 mo | U-1640 |
