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Last Updated: April 19, 2024

Details for New Drug Application (NDA): 022321


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NDA 022321 describes EMBEDA, which is a drug marketed by Alpharma Pharms and is included in one NDA. There are nine patents protecting this drug and four Paragraph IV challenges. Additional details are available on the EMBEDA profile page.

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:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG;0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Aug 13, 2009TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jun 19, 2027Product 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:⤷  Try a TrialPatent Expiration:Jun 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Dec 12, 2027Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-003 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-001 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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