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Last Updated: October 27, 2020

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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 five 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. Eighteen 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
Paragraph IV (Patent) Challenges for 204242
Tradename Dosage Ingredient NDA Submissiondate
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2017-05-04
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2015-12-21
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2015-07-24
ZUBSOLV TABLET;SUBLINGUAL buprenorphine hydrochloride; naloxone hydrochloride 204242 2013-10-22

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:  Start TrialPatent Expiration:May 22, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Patent:  Start TrialPatent Expiration:Dec 3, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE AND NALOXONE
Patent:  Start TrialPatent Expiration:Sep 18, 2032Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 204242

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Serving leading biopharmaceutical companies globally:

Moodys
McKesson
Mallinckrodt
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AstraZeneca
Boehringer Ingelheim

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