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Generated: June 22, 2018

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 zolpidem tartrate freedom to operate?

Zolpidem tartrate
is the generic ingredient in seven branded drugs marketed by Magna Pharms, Sanofi Aventis Us, Actavis Elizabeth, Actavis Labs Fl Inc, Anchen Pharms, Apotex Inc, Lupin Ltd, Sandoz, Sun Pharma Global, Synthon Pharms, Biovail Labs Intl, Acme Labs, Aurobindo Pharma, Cipla Ltd, Dr Reddys Labs Ltd, Hikma, Invagen Pharms, Mylan, Mylan Pharms Inc, Sandoz Inc, Sun Pharm Inds Inc, Sun Pharm Inds Ltd, Sun Pharm Industries, Teva, Torrent Pharms, Vintage, Vivimed Global, Watson Labs, Wockhardt, Yung Shin Pharm, Mylan Speciality Lp, Purdue Pharma, Dr Reddys Labs Inc, Novel Labs Inc, Par Form, and Par Pharm Inc, and is included in forty NDAs. There are ten 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-nine patent family members in thirty-six countries.

There are thirty-two drug master file entries for zolpidem tartrate. Sixty-five suppliers are listed for this compound. There are two tentative approvals for this compound.
Pharmacology for ZOLPIDEM TARTRATE
Synonyms for ZOLPIDEM TARTRATE
(2R,3R)-2,3-dihydroxybutanedioic acid; N,N-dimethyl-2-[6-methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl]acetamide
103188-50-7
2,3-bis(oxidanyl)butanedioic acid; N,N-dimethyl-2-[6-methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]ethanamide
2,3-dihydroxybutanedioic acid; N,N-dimethyl-2-[6-methyl-2-(4-methylphenyl)-3-imidazo[1,2-a]pyridinyl]acetamide
2,3-dihydroxybutanedioic acid; N,N-dimethyl-2-[6-methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl]acetamide
99294-93-6
A845992
AB04867
AC1L1N3L
ACT03353
AK126641
AKOS016013007
Ambap99294-93-6
AN-34491
API0004657
AX8157421
BEMA-Zolpidem
Bio-0153
CCG-100938
CHEMBL1723343
CPD000469145
EX-A1146
FK-199B
HE291113
HE421061
HMS2051H09
HMS2232G04
HMS3374C07
HMS3393H09
MFCD00214408
MLS001401453
N,N-dimethyl-2-(6-methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl)acetamide (2S,3S)-2,3-dihydroxysuccinate
N,N-Dimethyl-2-(6-methyl-2-(p-tolyl)imidazo[1,2-a]pyridin-3-yl)acetamide 2,3-dihydroxysuccinate
NC00188
NYVVVBWEVRSKIU-UHFFFAOYSA-N
OX-22
SAM001246549
SCHEMBL1653530
SCHEMBL40721
SL-80-0750-23N
SL-800750-23N
SMR000469145
T94Z936
Zolpidem MR
Zolpidem ODT
Tentative approvals for ZOLPIDEM TARTRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET;ORAL

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
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-001 Dec 16, 1992 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 200266-001 Sep 10, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc ZOLPIDEM TARTRATE zolpidem tartrate TABLET;ORAL 078016-002 Apr 23, 2007 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Sun Pharma Global ZOLPIDEM TARTRATE zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 204170-001 Jan 24, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Magna Pharms ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AMBIEN zolpidem tartrate TABLET;ORAL 019908-002 Dec 16, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Sanofi Aventis Us AMBIEN CR zolpidem tartrate TABLET, EXTENDED RELEASE;ORAL 021774-001 Sep 2, 2005 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Try a Free Trial
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain ➤ Try a Free Trial
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system ➤ Try a Free Trial
6,998,110 Buccal, polar and non-polar spray or capsule ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ZOLPIDEM TARTRATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
636 Luxembourg ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
4 Finland ➤ Try a Free Trial
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Express Scripts
Dow
Julphar
Johnson and Johnson
Medtronic
QuintilesIMS
Covington
US Army

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