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Serving hundreds of leading biopharmaceutical companies globally:

UBS
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US Army
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Farmers Insurance
Express Scripts
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Cipla
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Generated: July 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206544

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NDA 206544 describes MORPHABOND ER, which is a drug marketed by Daiichi Sankyo Inc and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the MORPHABOND ER profile page.

The generic ingredient in MORPHABOND ER is morphine sulfate. There are twenty-three drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the morphine sulfate profile page.
Summary for 206544
Tradename:MORPHABOND ER
Applicant:Daiichi Sankyo Inc
Ingredient:morphine sulfate
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details
Pharmacology for NDA: 206544
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for 206544
Suppliers and Packaging for NDA: 206544
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544 NDA Daiichi Sankyo Inc. 65597-301 N 65597-301-10
MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544 NDA Daiichi Sankyo Inc. 65597-302 N 65597-302-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength15MG
Approval Date:Oct 2, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2018
Regulatory Exclusivity Use:LABELING DESCRIBING THE EXPECTED REDUCTION OF ABUSE OF SINGLE-ENTITY MORPHINE BY THE INTRANASAL ROUTE OF ADMINISTRATION DUE TO PHYSICOCHEMICAL PROPERTIES
Patent:➤ Sign UpPatent Expiration:Aug 12, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength30MG
Approval Date:Oct 2, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Oct 2, 2018
Regulatory Exclusivity Use:LABELING DESCRIBING THE EXPECTED REDUCTION OF ABUSE OF SINGLE-ENTITY MORPHINE BY THE INTRANASAL ROUTE OF ADMINISTRATION DUE TO PHYSICOCHEMICAL PROPERTIES

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Argus Health
Julphar
Mallinckrodt
Dow
McKesson
Accenture
Cantor Fitzgerald
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