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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Merck
Express Scripts
Julphar
Farmers Insurance
Daiichi Sankyo
Cerilliant
US Department of Justice
Cipla

Generated: August 21, 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 fourteen patent family members in thirty-nine countries.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this compound. Twenty-two 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
Generic Entry Opportunity Date for ZUBSOLV
Generic Entry Date for ZUBSOLV*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;SUBLINGUAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 Date
➤ Subscribe Sublingual tablets 0.7 mg/0.18 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Tablets 2.9 mg/7.1 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Tablets 8.6 mg/2.1 mg and 11.4 mg/2.9 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Sublingual Tablets 1.4 mg/0.36 mg and 5.7 mg/1.4 mg ➤ Subscribe ➤ Try a Free Trial

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

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Supplementary Protection Certificates for ZUBSOLV

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

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Colorcon
Express Scripts
QuintilesIMS
Harvard Business School
Medtronic
Merck
Chubb

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