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 Almatica, Aytu, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Apotex, Breckenridge, Endo Operations, Lupin Ltd, Sandoz, Sun Pharm, Synthon Pharms, Biovail Labs Intl, Acme Labs, Apotex Inc, Aurobindo Pharma, Chartwell Molecular, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan Pharms Inc, Rising, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys, Norvium Bioscience, and Novel Labs Inc, and is included in forty-two NDAs. There are seven 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 forty-one patent family members in twenty-three countries.

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

Summary for ZOLPIDEM TARTRATE

International Patents:	141
US Patents:	7
Tradenames:	7
Applicants:	36
NDAs:	42
Drug Master File Entries:	32
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	24
Patent Applications:	1,068
Drug Prices:	Drug price trends for ZOLPIDEM TARTRATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZOLPIDEM TARTRATE
What excipients (inactive ingredients) are in ZOLPIDEM TARTRATE?	ZOLPIDEM TARTRATE excipients list
DailyMed Link:	ZOLPIDEM TARTRATE at DailyMed

See drug prices for ZOLPIDEM TARTRATE

Drug Sales Revenue Trends for ZOLPIDEM TARTRATE

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Recent Clinical Trials for ZOLPIDEM TARTRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Institute on Aging (NIA)	Phase 4
University of Pennsylvania	Phase 4
National Institutes of Health (NIH)	Phase 4

See all ZOLPIDEM TARTRATE clinical trials

Generic filers with tentative approvals for ZOLPIDEM TARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	10MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET;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

Drug Class	gamma-Aminobutyric Acid A Receptor Positive Modulator gamma-Aminobutyric Acid-ergic Agonist
Mechanism of Action	GABA A Receptor Positive Modulators GABA A Agonists
Physiological Effect	Central Nervous System Depression

Anatomical Therapeutic Chemical (ATC) Classes for ZOLPIDEM TARTRATE

N05CF	Benzodiazepine related drugs
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZOLPIDEM TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INTERMEZZO	Sublingual Tablets	zolpidem tartrate	1.75 mg and 3.5 mg	022328	1	2012-04-10
EDLUAR	Sublingual Tablets	zolpidem tartrate	5 mg and 10 mg	021997	1	2010-04-29
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	6.25 mg	021774	1	2006-02-24
AMBIEN CR	Extended-release Tablets	zolpidem tartrate	12.5 mg	021774	1	2006-01-19

US Patents and Regulatory Information for ZOLPIDEM TARTRATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	200266-002	Sep 10, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Purdue Pharma	INTERMEZZO	zolpidem tartrate	TABLET;SUBLINGUAL	022328-001	Nov 23, 2011		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Rising	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	076578-001	Apr 23, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novel Labs Inc	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;SUBLINGUAL	204299-002	Jun 3, 2015	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078016-002	Apr 23, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET;ORAL	078055-002	Apr 23, 2007		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ZOLPIDEM TARTRATE	zolpidem tartrate	TABLET, EXTENDED RELEASE;ORAL	200266-001	Sep 10, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

International Patents for ZOLPIDEM TARTRATE

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Country	Patent Number	Title	Estimated Expiration
New Zealand	561128	Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the gastrointestinal tract or urinary tract	⤷ Sign Up
Canada	2609330	COMPOSITIONS SOLIDES ET TECHNIQUES DE TRAITEMENT D'INSOMNIE SURVENANT AU MILIEU DE LA NUIT (SOLID COMPOSITIONS AND METHODS FOR TREATING MIDDLE-OF-THE NIGHT INSOMNIA)	⤷ Sign Up
European Patent Office	1807156	NOUVELLES PREPARATIONS PHARMACEUTIQUES UTILES DANS LE TRAITEMENT DE L'INSOMNIE (NEW PHARMACEUTICAL FORMULATIONS USEFUL IN THE TREATMENT OF INSOMNIA)	⤷ Sign Up
Poland	1807156		⤷ Sign Up
Canada	2582008	SPRAY NON POLAIRE, POLAIRE ET BUCCAL CONTENANT DU SUMATRIPTAN (BUCCAL, POLAR AND NON-POLAR SPRAY CONTAINING SUMATRIPTAN)	⤷ Sign Up
Australia	2006249761	Solid compositions and methods for treating middle-of-the night insomnia	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2004019909		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for ZOLPIDEM TARTRATE

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

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