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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Express Scripts
Julphar
McKesson
UBS
Cerilliant
Chinese Patent Office
Merck
QuintilesIMS

Generated: February 23, 2018

DrugPatentWatch Database Preview

Orexo Us Inc Company Profile

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What is the competitive landscape for OREXO US INC, and when can generic versions of OREXO US INC drugs launch?

OREXO US INC has one approved drug.

There are six US patents protecting OREXO US INC drugs and there have been three Paragraph IV challenges on OREXO US INC drugs in the past three years.

There are ninety-eight patent family members on OREXO US INC drugs in thirty-nine countries and six supplementary protection certificates in five countries.

Summary for Orexo Us Inc
International Patents:98
US Patents:6
Tradenames:1
Ingredients:1
NDAs:1

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 8,470,361 ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-006 Oct 4, 2016 RX Yes No 9,259,421 ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-003 Dec 11, 2014 RX Yes No 8,454,996 ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes 8,940,330 ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-005 Jun 4, 2015 RX Yes No 8,454,996 ➤ Sign Up ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-004 Dec 11, 2014 RX Yes Yes 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 9,439,900 ➤ Sign Up Y ➤ Sign Up
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-002 Jul 3, 2013 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 8,658,198 ➤ Sign Up Y ➤ 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 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 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
8,980,305 Non-abusable pharmaceutical composition comprising opioids ➤ Sign Up
7,910,132 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
8,512,747 Pharmaceutical composition for the treatment of acute disorders ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for Orexo Us Inc Drugs

Supplementary Protection Certificates for Orexo Us Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 Finland ➤ Sign Up
636 Luxembourg ➤ Sign Up PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714 Netherlands ➤ Sign Up PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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
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
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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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:

Queensland Health
Deloitte
Federal Trade Commission
Express Scripts
QuintilesIMS
Boehringer Ingelheim
Daiichi Sankyo
Merck
UBS

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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