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ZUBSOLV Drug Profile

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Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and three Paragraph IV challenges.

This drug has eighty-four patent family members in thirty-eight countries.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

Summary for Tradename: ZUBSOLV

Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details
Drug Prices: :see details

Pharmacology for Tradename: ZUBSOLV

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-004Dec 11, 2014RXNo9,439,900► subscribeY ► subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-003Dec 11, 2014RXNo9,439,900► subscribeY ► subscribe
Orexo Us Inc
ZUBSOLV
buprenorphine hydrochloride; naloxone hydrochloride
TABLET;SUBLINGUAL204242-002Jul 3, 2013RXYes► subscribe► subscribe
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Paragraph IV activity for: ZUBSOLV

Drugname Dosage Strength RLD Submissiondate
buprenorphine hydrochloride and naloxone hydrochloride dihydrate Sublingual Tablets2.9 mg/7.1 mgZubsolv12/21/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrateSublingual Tablets8.6 mg/2.1 mg and 11.4 mg/2.9 mgZubsolv7/24/2015
buprenorphine hydrochloride and naloxone hydrochloride dihydrateSublingual Tablets1.4 mg/0.36 mg and 5.7 mg/1.4 mgZubsolv10/22/2013

Non-Orange Book Patents for Tradename: ZUBSOLV

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
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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 Tradename: ZUBSOLV

Country Document Number Estimated Expiration
Norway332226► subscribe
Denmark1652518► subscribe
Japan2002526439► 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 Tradename: ZUBSOLV

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