Viewing data from:

AMBIEN CR

NDA

ZOLPIDEM TARTRATE | N021774 | COSETTE PHARMACEUTICALS INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

5 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Cover Letter RE Suitability Petition from Noble Pharma, LLC FDA-2022-P-1642 · 5 docket documents Noble Pharma, LLC filed a suitability petition requesting that the FDA determine whether brand name drug products containing zolpidem tartrate are suitable for over-the-counter marketing, seeking regulatory clarification on the feasibility of switching these prescription sleep aids to nonprescriptio	Suitability	2022-07-21	Granted	Noble Pharma, LLC
Lachman Consultant Services, Inc. - Citizen Petition FDA-2010-P-0015 · 6 docket documents Lachman Consultant Services, Inc. filed this citizen petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Tablets, 7.5 mg, suitable for submission as an ANDA, with Ambien Tablets 10 mg as the reference-	Other	2010-01-11	Denied	—
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0248 · 7 docket documents Lachman Consultant Services, Inc. filed this petition on May 26, 2009 pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Effervescent Tablets in 5 mg and 10 mg strengths suitable for submission as an ANDA, with Ambien zolpid	Other	2009-06-02	Open	—
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0063 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of MonoSol Rx, LLC pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Zolpidem Tartrate Orally-Dissolving Strips in 5 mg and 10 mg strengths suitable for consideration in an abbre	Other	2008-07-10	Withdrawn	Lachman Consultant Services, Inc.
sanofi aventis - Citizen Petition FDA-2007-P-0182 · 13 docket documents Sanofi-aventis U.S. LLC filed this citizen petition under section 505(b) and 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA take special consideration when reviewing any abbreviated new drug application for a generic version of AMBIEN CR (zolpidem tartrate extended-releas	505(q)	2008-05-06	Partially Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

107 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 92 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Comparison of the Physiological and Behavioral Effects of Suvorexant and Zolpidem in Healthy Volunteers: A Randomized, Double-blind, Placebo Controlled Study NCT04273776	Early Phase 1	Active	Walter Reed Army Institute of Research (WRAIR)	90	2019-12-01 → 2025-12-12
Central Sleep Apnea : Physiologic Mechanisms to Inform Treatment NCT04118387	Phase 4	Recruiting	VA Office of Research and Development	200	2021-01-07 → 2026-12-31
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 3.5 mg Formulation NCT02817750	Phase 1	Completed	Biolab Sanus Farmaceutica	28	2017-07-05 → 2018-02-22
Improving Sleep Quality in Heart Failure NCT03307005	Phase 4	Completed	Johns Hopkins University	5	2017-11-01 → 2019-01-25
Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users NCT01987739	Phase 1	Completed	Midnight Pharma, LLC	42	2009-09 → 2010-02
Xyrem(Sodium Oxybate) and Ambien(Zolpidem Tartrate) in the Treatment of Chronic Insomnia.NCT00383643	Phase 2	Completed	Stanford University	48	2006-05 → 2009-12
Efficacy, Safety, and Tolerability of Ambien (Zolpidem) in the Treatment of Children Ages 6 to 17 With Attention Deficit Hyperactivity Disorder (ADHD)-Associated Insomnia NCT00318448	Phase 3	Completed	Sanofi	201	2006-04 → 2006-08
A Double-blind, Group-comparison P-III Study With Zolpidem MR Using Placebo and Nitrazepam in Insomnia Patients NCT00374777	Phase 3	Completed	Astellas Pharma Inc	450	2006-08 → 2008-06
Bioequivalence Study of Zolpidem Tartrate Tablets and Ambien® Under Fasting Conditions NCT00684814	Phase 1	Completed	Mutual Pharmaceutical Company, Inc.	38	2004-05 → 2004-05
Effect Of Treatment With Oral Zolpidem On Polysomnography And Actigraphy Measures In Healthy Volunteers NCT00716521	Phase 1	Completed	Pfizer	11	2008-07 → 2008-10

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$22.57

per ea

Lowest NADAC/Unit

$22.57

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00713552101AMBIEN CR 12.5 MG TABLET	$22.57	EA	Brand	$0.1124	2026-02-13
00024552131AMBIEN CR 12.5 MG TABLET	$22.57	EA	Brand	$0.1124	2026-02-13

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (4 FSS, 2 Big4)

Lowest Price

$863.77

Highest Price

$911.48

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00713-5521-01ZOLPIDEM TARTRATE 12.5MG TAB,SA	$911.48	FSS	Cosette Pharmaceutical, Inc.	08/14/2027
00024-5521-31AMBIEN CR 12.5MG TAB	$863.77	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00024-5521-31AMBIEN CR 12.5MG TAB	$863.77	Big4	Sanofi Aventis U.S. LLC	05/31/2028
00024-5501-31AMBIEN CR 6.25MG TAB	$863.77	FSS	Sanofi Aventis U.S. LLC	05/31/2028
00024-5501-31AMBIEN CR 6.25MG TAB	$863.77	Big4	Sanofi Aventis U.S. LLC	05/31/2028
00713-5501-01ZOLPIDEM TARTRATE 6.25MG TAB,SA	$911.48	FSS	Cosette Pharmaceutical, Inc.	08/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Ambien Cr (2024)

Total Spending

$5.7M

Total Claims

7,083

Beneficiaries

1,218

Avg Cost/Unit

$20.50

Spending Trend

$7.4M(2019)→$7.7M(2020)→$7.7M(2021)→$5.8M(2022)→$5.9M(2023)→$5.7M(2024)

YoY Change:-5.6%

5yr CAGR:+3.3%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain20 active DMFs14 inactive

19 active API suppliers hold Drug Master Files for this ingredient.

HOLIDAY LABS MEXICO SA DE CVZOLPIDEM TARTRATE

DMF 151312000

FARMAK ASZOLPIDEM TARTRATE

DMF 154862001

TAPI NL BVZOLPIDEM TARTRATE

DMF 159582002

CAMBREX PROFARMACO MILANO SRLZOLPIDEM TARTRATE

DMF 170982003

SUN PHARMACEUTICAL INDUSTRIES LTDZOLPIDEM TARTRATE USP

DMF 177122004

ALIVUS LIFE SCIENCES LTDZOLPIDEM TARTRATE USP

DMF 181642005

MATRIX PHARMACORP PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 182212005

LUPIN LTDZOLPIDEM TARTRATE USP

DMF 184302005

DR REDDYS LABORATORIES LTDZOLPIDEM TARTRATE

DMF 188642005

APITORIA PHARMA PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 189742005

WOCKHARDT LTDZOLPIDEM TARTRATE

DMF 192892006

AARTI DRUGS LTDZOLPIDEM TARTRATE

DMF 194402006

ORCHID PHARMA LTDZOLPIDEM TARTRATE

DMF 198122006

SANOFI WINTHROP INDUSTRIEZOLPIDEM TARTRATE

DMF 209842007

UNICHEM LABORATORIES LTDZOLPIDEM TARTRATE USP

DMF 211932007

CENTAUR PHARMACEUTICALS PRIVATE LTDZOLPIDEM TARTRATE USP

DMF 307812016

ALIVUS LIFE SCIENCES LTDZOLPIDEM TARTRATE USP

DMF 318942017

YUNG ZIP CHEMICAL IND CO LTDZOLPIDEM TARTRATE

DMF 322522018

LUNAN BETTER PHARMACEUTICAL CO LTDZOLPIDEM TARTRATE USP

DMF 364722021

TORRENT PHARMACEUTICALS LTDZOLPIDEM TARTRATE USP

DMF 379982023

LABORATOIRES DETUDES ET DE RECHERCHES SYNTHELABOInactiveZOLPIDEM TARTRATE

DMF 66221986

SYNTHELABO BPInactiveZOLPIDEM TARTRATE

DMF 91591991

FINORGA SASInactiveZOLPIDEM TARTRATE MODIFIED SYNTHESIS

DMF 117641995

QUIMICA SINTETICA SAInactiveZOLPIDEM TARTRATE

DMF 158402002

ZENTIVA KSInactiveZOLPIDEM TARTRATE

DMF 166242003

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveZOLPIDEM TARTRATE

DMF 169402003

CIPLA LTDInactiveZOLPIDEM TARTRATE BP/PH.EUR.

DMF 178112004

SHANDONG LUNAN BETTER PHARMACEUTICAL CO LTDInactiveZOLPIDEM TARTRATE (NON-STERILE BULK FORM)

DMF 186972005

DIVIS LABORATORIES LTDInactiveZOLPIDEM TARTRATE USP

DMF 188082005

TEVA PHARMACEUTICAL INDUSTRIES LTDInactiveZOLPIDEM TARTRATE

DMF 189822005

CADILA PHARMACEUTICALS LTDInactiveZOLPIDEM TARTRATE

DMF 189862005

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveZOLPIDEM TARTRATE DRUG SUBSTANCE

DMF 190362005

CADILA HEALTHCARE LTDInactiveZOLPIDEM TARTRATE

DMF 192242006

SYNTHON BVInactiveZOLPIDEM TARTRATE

DMF 226682009

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

19 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2022	SUPPL -21	View Letter (PDF)
Feb 24, 2022	SUPPL -25	View Letter (PDF)
Feb 24, 2022	SUPPL -28	View Letter (PDF)
Aug 20, 2019	SUPPL -27	View Letter (PDF)
Feb 14, 2019	SUPPL -26	View Letter (PDF)
Sep 18, 2018	SUPPL -23	View Letter (PDF)
Mar 8, 2017	SUPPL -19	View Letter (PDF)
Dec 6, 2016	SUPPL -18	View Letter (PDF)
Aug 12, 2016	SUPPL -17	View Letter (PDF)
Oct 9, 2014	SUPPL -16	View Letter (PDF)
Apr 24, 2013	SUPPL -13	View Letter (PDF)
Apr 24, 2013	SUPPL -15	View Letter (PDF)
Apr 19, 2010	SUPPL -10	View Letter (PDF)
Jan 9, 2008	SUPPL -8	View Letter (PDF)
Jan 9, 2008	SUPPL -7	View Letter (PDF)
Jan 9, 2008	SUPPL -5	View Letter (PDF)
Jan 9, 2008	SUPPL -3	View Letter (PDF)
Jan 9, 2008	SUPPL -4	View Letter (PDF)
Sep 8, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 12.5MG

RLDAB

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 2, 2005

No patent or exclusivity listings for this strength.

#002 — 6.25MG

RLDAB

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: Sep 2, 2005