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Last Updated: August 12, 2020

DrugPatentWatch Database Preview

ZOLPIDEM TARTRATE - Generic Drug Details

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What are the generic drug sources for zolpidem tartrate and what is the scope of patent protection?

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

Zolpidem tartrate has one hundred and seventy-eight patent family members in thirty-one countries.

There are thirty-three drug master file entries for zolpidem tartrate. Forty-nine suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for ZOLPIDEM TARTRATE

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Drug Sales Revenue Trends for ZOLPIDEM TARTRATE

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Recent Clinical Trials for ZOLPIDEM TARTRATE

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SponsorPhase
National Institute on Aging (NIA)Phase 4
National Institutes of Health (NIH)Phase 4
University of PennsylvaniaPhase 4

See all ZOLPIDEM TARTRATE clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET;ORAL
  Start Trial  Start Trial5MGTABLET;ORAL
  Start Trial  Start Trial10MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ZOLPIDEM TARTRATE
Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
INTERMEZZO TABLET;SUBLINGUAL zolpidem tartrate 022328 2012-04-10
EDLUAR TABLET;SUBLINGUAL zolpidem tartrate 021997 2010-04-29
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 2006-02-24
AMBIEN CR TABLET, EXTENDED RELEASE;ORAL zolpidem tartrate 021774 2006-01-19

US Patents and Regulatory Information for ZOLPIDEM TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Biovail Labs Intl TOVALT ODT zolpidem tartrate TABLET, ORALLY DISINTEGRATING;ORAL 021412-001 Apr 25, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077322-002 Apr 23, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 090107-002 Jul 1, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Synthon Pharms ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 077540-001 Apr 23, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Vintage ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078616-001 Nov 21, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ZOLPIDEM TARTRATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992   Start Trial   Start Trial
Aytu ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008   Start Trial   Start Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992   Start Trial   Start Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-002 Sep 2, 2005   Start Trial   Start Trial
Mylan Speciality Lp EDLUAR zolpidem tartrate TABLET;SUBLINGUAL 021997-001 Mar 13, 2009   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for ZOLPIDEM TARTRATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2236132 C300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132 122015000006 Germany   Start Trial PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132 CA 2015 00004 Denmark   Start Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
Medtronic
Moodys
Express Scripts
Colorcon

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