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Last Updated: November 20, 2019

DrugPatentWatch Database Preview

ZUBSOLV Drug Profile

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Which patents cover Zubsolv, and what generic alternatives are available?

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 seventeen 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. Twenty suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Drug patent expirations by year for ZUBSOLV
Drug Prices for ZUBSOLV

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Recent Clinical Trials for ZUBSOLV

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SponsorPhase
Johns Hopkins UniversityPhase 2
Indivior Inc.Phase 4
Worldwide Clinical TrialsPhase 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
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 204242-006 Oct 4, 2016 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No   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

Supplementary Protection Certificates for ZUBSOLV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 484 Finland   Start Trial
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark   Start Trial PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
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 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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