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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Accenture
Baxter
McKinsey
Farmers Insurance
Queensland Health
Fuji
Cerilliant
Chinese Patent Office

Generated: September 20, 2018

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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.

Summary for Orexo Us Inc
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 204242-005 Jun 4, 2015 RX Yes No 8,454,996 ➤ Try a Free Trial ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-001 Jul 3, 2013 RX Yes No 9,259,421 ➤ Try a Free Trial Y ➤ Try a Free Trial
Orexo Us Inc ZUBSOLV buprenorphine hydrochloride; naloxone hydrochloride TABLET;SUBLINGUAL 204242-001 Jul 3, 2013 RX Yes No 8,454,996 ➤ 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 8,940,330 ➤ 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 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 ➤ Try a Free Trial
8,980,305 Non-abusable pharmaceutical composition comprising opioids ➤ 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
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
4 Finland ➤ Try a Free Trial
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
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
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Argus Health
Citi
Julphar
US Department of Justice
Moodys
Cipla
Dow

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