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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
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Johnson and Johnson
Citi
Julphar
Argus Health

Generated: October 15, 2018

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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.

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.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 ➤ Sign Up
➤ Subscribe Sublingual Tablets 2.9 mg/7.1 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Sublingual Tablets 8.6 mg/2.1 mg and 11.4 mg/2.9 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Sublingual Tablets 1.4 mg/0.36 mg and 5.7 mg/1.4 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for ZUBSOLV

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015000006 Germany ➤ Sign Up 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 ➤ Sign Up 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:

Baxter
Farmers Insurance
Federal Trade Commission
Moodys
Dow
Johnson and Johnson
Citi
Julphar
Argus Health

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