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Last Updated: May 19, 2022

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 nine 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
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 54123-114-30 3 BLISTER PACK in 1 CARTON (54123-114-30) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242 NDA Orexo US, Inc. 54123-907 54123-907-30 3 BLISTER PACK in 1 CARTON (54123-907-30) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

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
Patent:See Plans and PricingPatent Expiration:Sep 18, 2032Product Flag?YSubstance Flag?Delist Request?
Patent:See Plans and PricingPatent Expiration:Sep 18, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF ZUBSOLV FOR TREATMENT OF OPIOID DEPENDENCE
Patent:See Plans and PricingPatent Expiration:May 22, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE

Expired US Patents for NDA 204242

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Serving leading biopharmaceutical companies globally:

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.