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Generated: October 20, 2017

DrugPatentWatch Database Preview

ZOLPIDEM TARTRATE - Generic Drug Details

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What are the generic sources for zolpidem tartrate and what is the scope of zolpidem tartrate freedom to operate?

Zolpidem tartrate
is the generic ingredient in seven branded drugs marketed by Torrent Pharms, Dr Reddys Labs Inc, Sandoz, Sanofi Aventis Us, Par Form, Teva, Biovail Labs Intl, Aurobindo Pharma, Allied Pharma Inc, Mylan Pharms Inc, Vintage, Sandoz Inc, Wockhardt, Purdue Pharma, Hikma, Par Pharm Inc, Synthon Pharms, Anchen Pharms, Actavis Labs Fl Inc, Sun Pharm Inds Ltd, Sun Pharm Inds Inc, Vivimed Global, Apotex Inc, Lupin Ltd, Sun Pharma Global, Watson Labs, Mylan, Actavis Elizabeth, Invagen Pharms, Dr Reddys Labs Ltd, Cipla Ltd, Sun Pharm Inds, Yung Shin Pharm, Magna Pharms, Mylan Speciality Lp, and Novel Labs Inc, and is included in forty NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Zolpidem tartrate has two hundred and forty-three patent family members in thirty-six countries and five supplementary protection certificates in five countries.

There are thirty-one drug master file entries for zolpidem tartrate. Sixty-eight suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for Generic Name: ZOLPIDEM TARTRATE

US Patents:11
Tradenames:7
Applicants:36
NDAs:40
Drug Master File Entries: see list31
Suppliers / Packagers: see list68
Bulk Api Vendors: see list30
Clinical Trials: see list232
Patent Applications: see list930
Therapeutic Class:Sedatives/Hypnotics
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:ZOLPIDEM TARTRATE at DailyMed

Pharmacology for Ingredient: ZOLPIDEM TARTRATE

Tentative approvals for ZOLPIDEM TARTRATE

Applicant Application No. Strength Dosage Form
u► Subscribe5MGTABLET;ORAL
u► Subscribe10MGTABLET;ORAL
u► Subscribe10MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL078413-001May 4, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Inc
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL077359-002Apr 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Speciality Lp
EDLUAR
zolpidem tartrate
TABLET;SUBLINGUAL021997-002Mar 13, 2009ABRXYesYes► Subscribe► Subscribe ► Subscribe
Synthon Pharms
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL077540-002Apr 23, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL078970-001Sep 11, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Invagen Pharms
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL078184-002Sep 7, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL076410-002Apr 23, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-001Dec 16, 1992ABRXYesNo► Subscribe► Subscribe► Subscribe
Dr Reddys Labs Ltd
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;ORAL077985-002Apr 23, 2007DISCNNoNo► Subscribe► Subscribe► Subscribe
Novel Labs Inc
ZOLPIDEM TARTRATE
zolpidem tartrate
TABLET;SUBLINGUAL204299-002Jun 3, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: zolpidem tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Magna Pharms
ZOLPIMIST
zolpidem tartrate
SPRAY, METERED;ORAL022196-001Dec 19, 2008► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-001Dec 16, 1992► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-002Sep 2, 2005► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN CR
zolpidem tartrate
TABLET, EXTENDED RELEASE;ORAL021774-001Sep 2, 2005► Subscribe► Subscribe
Sanofi Aventis Us
AMBIEN
zolpidem tartrate
TABLET;ORAL019908-002Dec 16, 1992► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: zolpidem tartrate

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
7,910,132Pharmaceutical composition for the treatment of acute disorders► Subscribe
8,097,431Methods and compositions for detecting steroids► Subscribe
6,998,110Buccal, polar and non-polar spray or capsule► Subscribe
9,078,816Buccal, polar and non-polar spray containing ondansetron► Subscribe
8,454,996Pharmaceutical composition for the treatment of acute disorders► Subscribe
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain► Subscribe
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system► 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 Ingredient: zolpidem tartrate

Country Document Number Estimated Expiration
Australia2003262917► Subscribe
Denmark1135125► Subscribe
New Zealand510284► Subscribe
World Intellectual Property Organization (WIPO)2004035021► Subscribe
Japan2006505611► Subscribe
World Intellectual Property Organization (WIPO)2004043428► Subscribe
Russian Federation2193879► Subscribe
Denmark2340872► Subscribe
European Patent Office1883408► Subscribe
Hungary230468► 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: ZOLPIDEM TARTRATE

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
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
4Finland► Subscribe
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Citi
US Army
Federal Trade Commission
Covington
Novartis
Fish and Richardson
Cipla
Medtronic
Argus Health

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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