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Last Updated: April 3, 2020

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ZUBSOLV Drug Profile


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When do Zubsolv patents expire, and when can generic versions of Zubsolv launch?

Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and twenty patent family members in forty countries.

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.

US ANDA Litigation and Generic Entry Outlook for Zubsolv

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (buprenorphine hydrochloride; naloxone hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for ZUBSOLV
Drug Prices for ZUBSOLV

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Recent Clinical Trials for ZUBSOLV

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Johns Hopkins UniversityPhase 2
Indivior Inc.Phase 4
Orexo ABPhase 4

See all ZUBSOLV clinical trials

Recent Litigation for ZUBSOLV

Identify potential future generic entrants

District Court Litigation
Case NameDate
Orexo AB v. Actavis Elizabeth LLC2017-06-14
Orexo AB v. Actavis Elizabeth LLC2017-02-28
Orexo AB v. Actavis Elizabeth LLC2016-07-07

See all ZUBSOLV litigation

Synonyms for ZUBSOLV
352020-56-5
Bunavail
Buprenorphine / Naloxone
Buprenorphine and Naloxone
Buprenorphine hydrochloride and naloxone hydrochloride
Buprenorphine mixture with Naloxone
Buprenorphine-Naloxone
buprenorphine-naloxone combination
Buprenorphine, Naloxone Drug Combination
DTXSID50188706
Naloxone-Buprenorphine
Paragraph IV (Patent) Challenges for ZUBSOLV
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

US Patents and Regulatory Information for ZUBSOLV

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZUBSOLV

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

Supplementary Protection Certificates for ZUBSOLV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 122015000006 Germany   Start Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 484 Finland   Start Trial
2236132 C300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Medtronic
Moodys
Boehringer Ingelheim
Johnson and Johnson

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.