.

Deeper Knowledge, Faster

  • Identify first generic entrants
  • Obtain formulation and manufacturing information
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Cerilliant
McKesson
Queensland Health
Chubb
McKinsey
Harvard Business School
Merck
Moodys
Cipla
Daiichi Sankyo

Generated: November 21, 2017

DrugPatentWatch Database Preview

Orexo Us Inc Company Profile

« Back to Dashboard

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

Summary for Orexo Us Inc

International Patents:96
US Patents:6
Tradenames:1
Ingredients:1
NDAs:1
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;SUBLINGUAL204242-005Jun 4, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXYesNo► Subscribe► Subscribe► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-006Oct 4, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-001Jul 3, 2013RXYesNo► Subscribe► SubscribeY ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-005Jun 4, 2015RXYesNo► Subscribe► Subscribe ► Subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYesNo► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV activity for OREXO US INC drugs

Drugname Dosage Strength Tradename Submissiondate
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sublingual tablets0.7 mg/0.18 mg
ZUBSOLV
5/3/2017
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sublingual Tablets2.9 mg/7.1 mg
ZUBSOLV
12/21/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sublingual Tablets8.6 mg/2.1 mg and 11.4 mg/2.9 mg
ZUBSOLV
7/24/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrate
Sublingual Tablets1.4 mg/0.36 mg and 5.7 mg/1.4 mg
ZUBSOLV
10/22/2013

Non-Orange Book 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► Subscribe
8,980,305Non-abusable pharmaceutical composition comprising opioids► Subscribe
8,512,747Pharmaceutical composition for the treatment of acute disorders► Subscribe
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Orexo Us Inc Drugs

Country Document Number Estimated Expiration
Japan2002526439► Subscribe
Japan2017171687► Subscribe
Estonia200800028► Subscribe
Hong Kong1091722► Subscribe
China1173694► Subscribe
Czech Republic302975► Subscribe
South Korea20140075682► Subscribe
Spain2433930► Subscribe
European Patent Office1652518► Subscribe
Germany69936393► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Orexo Us Inc Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
4Finland► Subscribe
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
0714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015 00004Denmark► SubscribePRODUCT 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Fish and Richardson
McKinsey
Teva
Cerilliant
Farmers Insurance
Argus Health
Cantor Fitzgerald
Chubb
Merck
Boehringer Ingelheim

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot