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Last Updated: July 11, 2020

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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
Generic Entry Opportunity 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.

Paragraph IV (Patent) Challenges for 022321
Tradename Dosage Ingredient NDA Submissiondate
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2018-08-16
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-28
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-25
EMBEDA CAPSULE, EXTENDED RELEASE;ORAL morphine sulfate; naltrexone hydrochloride 022321 2010-05-03

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE, EXTENDED RELEASE;ORALStrength20MG;0.8MG
Approval Date:Aug 13, 2009TE:RLD:Yes
Patent:  Start 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 TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
Patent:  Start TrialPatent Expiration:Jun 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patent:  Start 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 022321-001 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-005 Aug 13, 2009   Start Trial   Start Trial
Alpharma Pharms EMBEDA morphine sulfate; naltrexone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 022321-002 Aug 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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