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NDA

ZALEPLON | N020859 | PFIZER 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

2 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Daniel F. Kripke, MD (The Weston Firm) FDA-2015-P-3959 · 6 docket documents Dr. Daniel F. Kripke filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA take multiple administrative actions regarding hypnotic drugs including zolpidem, temazepam, eszopiclone, zaleplon, triazolam, flurazepam, quazepam, and barbiturates such as pentobarbital, amobarbital, a	Other	2015-12-16	Open	Daniel F. Kripke, MD (The Weston Firm)
Lachman Consultant Services, Inc. - Citizen Petition FDA-2007-P-0289 · 6 docket documents Lachman Consultant Services, Inc. filed this petition on behalf of a client requesting that the FDA declare Zaleplon Capsules, 7.5 mg, suitable for submission as an abbreviated new drug application under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act, with the reference listed drug	Other	2008-05-16	Granted	—

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

Clinical Trials

11 trials from ClinicalTrials.gov, 10 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Staccato Zaleplon Single Dose Pharmacokinetics NCT00620620	Phase 1	Completed	Alexza Pharmaceuticals, Inc.	40	2008-02 → 2008-03
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fasting Conditions NCT00694187	N/A	Completed	Roxane Laboratories	39	2004-01 → 2004-02
Optimize Astronaut Sleep Medication Efficacy and Individual Effects NCT03526575	Phase 4	Completed	National Aeronautics and Space Administration (NASA)	34	2011-01-10 → 2015-07-15
Zaleplon 10 mg Capsules Under Non-Fasting Conditions NCT00829868	Phase 1	Completed	Teva Pharmaceuticals USA	42	2004-02 → 2004-03
Zaleplon 10mg Capsules Under Fasting Conditions NCT00829998	Phase 1	Completed	Teva Pharmaceuticals USA	40	2004-02 → 2004-02
Hypnotic Medications and Memory: Effect of Drug Exposure During the Night NCT01159652	Phase 4	Completed	St. Luke's Hospital, Chesterfield, Missouri	26	2010-10 → 2011-05
Bioequivalency Study of Zaleplon 10 mg Capsules Under Fed Conditions NCT00694317	N/A	Completed	Roxane Laboratories	40	2004-02 → 2004-02
Study of Sleep-maintenance Activity of 3 Doses of SKP-1041 NCT00878553	Phase 2	Completed	Somnus Therapeutics, Inc.	67	2010-05 → 2011-08
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia NCT01277107	Phase 2	Completed	Intec Pharma Ltd.	83	2011-01 → 2011-09
Zaleplon in HIV Patients With Depression NCT03489304	Phase 2	Completed	University of Pennsylvania	20	2014-04-03 → 2015-02-04

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

Medicare Part D Spending

CMS annual spending data for Zaleplon (2024)

Total Spending

$3.6M

Total Claims

176,024

Beneficiaries

49,782

Avg Cost/Unit

$0.52

Spending Trend

$4.2M(2019)→$4.4M(2020)→$4.6M(2021)→$4.8M(2022)→$4.9M(2023)→$3.6M(2024)

YoY Change:-29.1%

5yr CAGR:-5.5%

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

API Supply Chain4 active DMFs8 inactive

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

TAPI NL BVZALEPLON

DMF 175652004

APITORIA PHARMA PRIVATE LTDZALEPLON USP

DMF 193982006

ORBION PHARMACEUTICALS PRIVATE LTDZALEPLON

DMF 208772007

CENTAUR PHARMACEUTICALS PVT LTDZALEPLON USP

DMF 275682013

ZACH SYSTEM SPAInactiveZALEPLON

DMF 117471995

AMINO CHEMICALS LTDInactiveZALEPLON

DMF 167852003

MEDICHEM SAInactiveZALEPLON

DMF 172302004

CIPLA LTDInactiveZALEPLON

DMF 180222005

GADOR SAInactiveZALEPLON

DMF 190152005

MEDICHEM MANUFACTURING (MALTA) LTDInactiveZALEPLON (MED - 201970)

DMF 194632006

CADILA HEALTHCARE LTDInactiveZALEPLON

DMF 214822008

APOTEX PHARMACHEM INCInactiveZALEPLON

DMF 225722009

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Aug 20, 2019	SUPPL -16	View Letter (PDF)
Feb 14, 2019	SUPPL -15	View Letter (PDF)
Apr 24, 2013	SUPPL -13	View Letter (PDF)
Jan 9, 2008	SUPPL -11	View Letter (PDF)
Jan 9, 2008	SUPPL -9	View Letter (PDF)
Jun 8, 2003	SUPPL -4	View Letter (PDF)
Jun 8, 2003	SUPPL -5	View Letter (PDF)
Jun 3, 2002	SUPPL -2	View Letter (PDF)
May 31, 2002	SUPPL -3	View Letter (PDF)
Feb 22, 2001	SUPPL -1	View Letter (PDF)
Aug 13, 1999	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 13, 1999

No patent or exclusivity listings for this strength.

#002 — 10MG

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 13, 1999