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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Healthtrust
Julphar
Queensland Health
Farmers Insurance
Express Scripts
Fuji
Fish and Richardson
Mallinckrodt

Generated: February 18, 2019

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

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
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

Supplementary Protection Certificates for ZUBSOLV

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Dow
UBS
Chinese Patent Office
Argus Health
Covington
Julphar
AstraZeneca
US Army
McKinsey

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