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Serving leading biopharmaceutical companies globally:

Chubb
Cipla
Deloitte
Dow
Federal Trade Commission
QuintilesIMS
Johnson and Johnson
US Army
Argus Health
Merck

Generated: January 17, 2018

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 eleven patent family members in thirty-eight countries.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.
Summary for ZUBSOLV
International Patents:111
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 4
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZUBSOLV at DailyMed
Drug patent expirations by year for ZUBSOLV

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ZUBSOLV
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Sublingual tablets 0.7 mg/0.18 mg ➤ Subscribe 5/3/2017
➤ Subscribe Sublingual Tablets 2.9 mg/7.1 mg ➤ Subscribe 12/21/2015
➤ Subscribe Sublingual Tablets 8.6 mg/2.1 mg and 11.4 mg/2.9 mg ➤ Subscribe 7/24/2015
➤ Subscribe Sublingual Tablets 1.4 mg/0.36 mg and 5.7 mg/1.4 mg ➤ Subscribe 10/22/2013

Non-Orange Book US Patents for ZUBSOLV

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,761,910 Pharmaceutical composition for the treatment of acute disorders ➤ Subscribe
7,910,132 Pharmaceutical composition for the treatment of acute disorders ➤ Subscribe
8,980,305 Non-abusable pharmaceutical composition comprising opioids ➤ Subscribe
8,512,747 Pharmaceutical composition for the treatment of acute disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for ZUBSOLV

Supplementary Protection Certificates for ZUBSOLV

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2015000006 Germany ➤ Subscribe 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
2015 00004 Denmark ➤ Subscribe 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
4 Finland ➤ Subscribe
0714 Netherlands ➤ Subscribe PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
636 Luxembourg ➤ Subscribe PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Federal Trade Commission
Baxter
Novartis
Julphar
UBS
Dow
Chubb
US Army

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.

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