Details for New Drug Application (NDA): 022321
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The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this compound. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.
Summary for 022321
Tradename: | EMBEDA |
Applicant: | Alpharma Pharms |
Ingredient: | morphine sulfate; naltrexone hydrochloride |
Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022321
Generic Entry Date for 022321*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Aug 13, 2009 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 19, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED. | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 19, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 12, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022321
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