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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Mallinckrodt
Harvard Business School
Baxter
Moodys
McKinsey
Cipla
Fish and Richardson
Accenture

Generated: July 21, 2018

DrugPatentWatch Database Preview

Orexo Us Inc Company Profile

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Summary for Orexo Us Inc
International Patents:98
US Patents:6
Tradenames:1
Ingredients:1
NDAs:1
Patent Litigation for Orexo Us Inc: See patent lawsuits for Orexo Us Inc

Drugs and US Patents for Orexo Us Inc

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 204242-003 Dec 11, 2014 RX Yes No 8,940,330 ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No 8,454,996 ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No 8,940,330 ➤ 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
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 OREXO US INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Sublingual Tablets 1.4 mg/0.36 mg and 5.7 mg/1.4 mg ➤ Subscribe 2013-10-22
➤ Subscribe Sublingual Tablets 2.9 mg/7.1 mg ➤ Subscribe 2015-12-21
➤ Subscribe Sublingual Tablets 8.6 mg/2.1 mg and 11.4 mg/2.9 mg ➤ Subscribe 2015-07-24
➤ Subscribe Sublingual tablets 0.7 mg/0.18 mg ➤ Subscribe 2017-05-03

Non-Orange Book US Patents for Orexo Us Inc

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

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Supplementary Protection Certificates for Orexo Us Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0714 Netherlands ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
4 Finland ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
US Department of Justice
Daiichi Sankyo
Boehringer Ingelheim
Covington
Argus Health
Fish and Richardson
Harvard Business School
Cerilliant

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.