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Generated: May 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204242

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NDA 204242 describes ZUBSOLV, which is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ZUBSOLV profile page.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for 204242
Tradename:ZUBSOLV
Applicant:Orexo Us Inc
Ingredient:buprenorphine hydrochloride; naloxone hydrochloride
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 204242
Suppliers and Packaging for NDA: 204242
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242 NDA Orexo US, Inc. 54123-114 N 54123-114-30
ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242 NDA Orexo US, Inc. 54123-907 N 54123-907-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;SUBLINGUALStrengthEQ 1.4MG BASE;EQ 0.36MG BASE
Approval Date:Jul 3, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Aug 10, 2018
Regulatory Exclusivity Use:REVISIONS TO THE LABELING TO PERMIT THE USE OF ZUBSOLV AS INITIAL ('INDUCTION') TREATMENT OF OPIOID DEPENDENCE
Patent:➤ Try a Free TrialPatent Expiration:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
Patent:➤ Try a Free TrialPatent Expiration:May 22, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

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