Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Medtronic
Merck
Colorcon
Harvard Business School

Last Updated: November 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204242

See Plans and Pricing

« Back to Dashboard

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 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:Sep 24, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
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

Expired US Patents for NDA 204242

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015   Start Trial   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016   Start Trial   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014   Start Trial   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Boehringer Ingelheim
McKinsey
McKesson
Baxter

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 verifification 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.