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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Novartis
QuintilesIMS
Healthtrust
Argus Health
Medtronic
Harvard Business School
Express Scripts
McKesson
Federal Trade Commission

Generated: July 24, 2017

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-three patent family members on OREXO US INC drugs in thirty-eight countries.

Summary for Applicant: Orexo Us Inc

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► Subscribe► 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► 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
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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
8,512,747Pharmaceutical composition for the treatment of acute disorders► Subscribe
8,980,305Non-abusable pharmaceutical composition comprising opioids► Subscribe
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
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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.

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International Patent Family for Orexo Us Inc Drugs

Country Document Number Estimated Expiration
Brazil112014006356► Subscribe
Norway20011473► Subscribe
Czech Republic302975► Subscribe
Slovenia2706986► Subscribe
Japan3381220► Subscribe
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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.

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Supplementary Protection Certificates for Orexo Us Inc Drugs

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

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

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Serving 500+ biopharmaceutical companies globally:

McKinsey
Fuji
Queensland Health
Johnson and Johnson
Accenture
Daiichi Sankyo
Cerilliant
Medtronic
Argus Health
Moodys

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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