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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Medtronic
Julphar
Accenture
Dow
Baxter
Novartis
Merck
Cipla
Teva

Generated: August 23, 2017

DrugPatentWatch Database Preview

ZOLPIMIST Drug Profile

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What is the patent landscape for Zolpimist, and when can generic versions of Zolpimist launch?

Zolpimist is a drug marketed by Amherst Pharms Llc and is included in one NDA. There are two patents protecting this drug.

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

The generic ingredient in ZOLPIMIST is zolpidem tartrate. There are thirty-one drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the zolpidem tartrate profile page.

Summary for Tradename: ZOLPIMIST

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ZOLPIMIST at DailyMed

Pharmacology for Tradename: ZOLPIMIST

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amherst Pharms Llc
ZOLPIMIST
zolpidem tartrate
SPRAY, METERED;ORAL022196-001Dec 19, 2008RXYesYes► Subscribe► SubscribeYY ► Subscribe
Amherst Pharms Llc
ZOLPIMIST
zolpidem tartrate
SPRAY, METERED;ORAL022196-001Dec 19, 2008RXYesYes► Subscribe► Subscribe ► Subscribe
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Premature patent expiration for: ZOLPIMIST

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
► Subscribe
ZOLPIMIST
► Subscribe

Non-Orange Book Patents for Tradename: ZOLPIMIST

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
6,676,931 Buccal, polar and non-polar spray or capsule► Subscribe
9,078,816Buccal, polar and non-polar spray containing ondansetron► Subscribe
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system► Subscribe
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain► Subscribe
6,998,110Buccal, polar and non-polar spray or capsule► 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: ZOLPIMIST

Country Document Number Estimated Expiration
Japan2006502150► Subscribe
South Korea20060120065► Subscribe
European Patent Office2277506► Subscribe
Japan2001517689► Subscribe
European Patent Office1036561► 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: ZOLPIMIST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Baxter
US Department of Justice
Daiichi Sankyo
Colorcon
Fuji
Farmers Insurance
AstraZeneca
Express Scripts
Julphar
Harvard Business School

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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