FDA Orange Book · active-ingredient family
Morphine sulfate; naltrexone hydrochloride
Morphine sulfate; 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:EMBEDA · NDA 022321
1
Brand (NDA)
0
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EMBEDARLD×6 | ALPHARMA PHARMS | NDA 022321 | — | Aug 13, 2009 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8158156 | Jun 19, 2027 | in 1 yr | U-1510 |
| 7682633 | Jun 19, 2027 | in 1 yr | U-1510 |
| 8846104 | Jun 19, 2027 | in 1 yr | Product |
| 7682634 | 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 |
Morphine sulfate; naltrexone hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
