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PHENERGAN

NDA

PROMETHAZINE HYDROCHLORIDE | N007935 | DELCOR ASSET CORP

3 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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

5 petitions (2 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Quagen Pharma LLC FDA-2026-P-8560 Quagen Pharma LLC filed a citizen petition requesting that the FDA declare the Active Pharmaceutical Ingredient 1,4-Benzenedicarboxylic acid, dimethyl ester (dimethyl terephthalate) suitable for use in pharmaceuticals as an excipient, enabling its use in drug formulations under appropriate regulator	Suitability	2026-08-04	Open	Quagen Pharma LLC
Citizen Petition from Public Citizen Health Research Group FDA-1976-N-0519 Public Citizen Health Research Group and the University of Maryland Sudden Infant Death Syndrome Institute filed this petition requesting that the FDA immediately ban all over-the-counter use of promethazine hydrochloride products including Phenergan DM and Phenergan VC, contraindicate prescription	Other	2011-03-25	Granted	Public Citizen Health Research Group
Citizens Petition from Buchanan Ingersoll FDA-2005-P-0376 Buchanan Ingersoll filed this citizen petition regarding Phenergan (promethazine HCI) tablets and suppositories. The petition requests that FDA revise the labeling to strengthen warnings about respiratory depression risks in pediatric patients and add a boxed warning highlighting the contraindicatio	Other	2009-06-04	Granted	Buchanan Ingersoll
Lachman Consultant Services, Inc. - Citizen Petition FDA-2009-P-0249 Lachman Consultant Services, Inc. filed this petition on May 26, 2009 pursuant to Section 505(j)(2)(C) requesting that the FDA declare Promethazine Hydrochloride Effervescent Tablets in 25 mg and 50 mg strengths suitable for submission as an ANDA, with the reference-listed drug being Sandoz's Promet	Other	2009-05-29	Withdrawn	—
Citizen Petition from Taro Pharmaceuticals USA, Inc. FDA-2006-P-0005 Taro Pharmaceuticals USA, Inc. filed this citizen petition on October 31, 2006, requesting that the FDA make a determination of ANDA suitability for Promethazine Hydrochloride Suppositories USP in 12.5 mg and 25 mg strengths, which were voluntarily withdrawn from sale by Wyeth for reasons other than	Other	2008-08-12	Open	Taro Pharmaceuticals USA, Inc.

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

Clinical Trials

27 trials from ClinicalTrials.gov, 20 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting NCT01474915	Phase 4	Completed	Sergio Bergese	122	2007-06 → 2013-04
A RCT of Ondansetron and Promethazine in the Treatment of Nausea and Vomiting in the Emergency Department NCT00429832	Phase 4	Completed	University of New Mexico	120	2003-10 → 2005-11
Promethazine vs. Lorazepam for Treatment of Vertigo NCT01827293	Phase 3	Completed	Shahid Beheshti University of Medical Sciences	210	2013-04 → 2013-06
A Controlled Study to Determine the Efficacy and Safety of CL-108 5 mg for Acute Pain and the Prevention of OINV NCT03657810	Phase 3	Completed	Charleston Laboratories, Inc	349	2017-08-02 → 2018-11-30
A Four-Period, Four-Treatment, Four-Way Relative Bioavailability Study of CL-108 Under Fed and Fasted Conditions NCT02465866	Phase 1	Completed	Charleston Laboratories, Inc	20	2014-11 → 2015-04
Single Dose Pharmacokinetics of Suboxone Study in Hepatic Impaired Subjects NCT01846455	Phase 4	Completed	Indivior Inc.	43	2012-09 → 2013-05
Improving Safety of Antivenom in People Bitten by Snakes NCT00270777	Phase 4	Completed	University of Kelaniya	1,000	2005-03 → 2008-04
A Study to Assess the Efficacy and Safety of Oral CL-H1T in the Treatment of Acute Migraine Pain NCT03877718	Phase 2	Completed	Charleston Laboratories, Inc	475	2019-02-01 → 2019-08-27
Efficacy and Safety of Oral Sumatriptan Plus Oral Promethazine in Migraine Treatment NCT01814189	Phase 3	Completed	Shahid Beheshti University of Medical Sciences	350	2013-01 → 2013-04
Intraoperative Acupoint Stimulation to Prevent Post-Operative Nausea and Vomiting (PONV)NCT02473042	N/A	Completed	M.D. Anderson Cancer Center	188	2016-03-01 → 2024-11-26

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

Medicare Part D Spending

CMS annual spending data for Phenergan (2024)

Total Spending

$6K

Total Claims

Beneficiaries

Avg Cost/Unit

$2.95

Spending Trend

$3K(2019)→$5K(2020)→$15K(2021)→$9K(2022)→$2K(2023)→$6K(2024)

YoY Change:-19.3%

5yr CAGR:-3.5%

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

Medicare Part B Spending

CMS physician-administered drug spending for Phenergan (2024)

Total Spending

$66K

Total Claims

18,818

Beneficiaries

11,901

ASP Price

$3.39

Spending Trend

$155K(2019)→$98K(2020)→$89K(2021)→$83K(2022)→$78K(2023)→$66K(2024)

YoY Change:+4.9%

5yr CAGR:+11.7%

HCPCS: J2550 — Injection, promethazine hcl, up to 50 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain3 active DMFs5 inactive

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

ZYDUS LIFESCIENCES LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 198402006

EMCURE PHARMACEUTICALS LTDPROMETHAZINE HYDROCHLORIDE USP

DMF 258062012

AREVA SYNTHETICS LLCPROMETHAZINE HYDROCHLORIDE USP

DMF 421762025

PHENCHEM INDUSTRIES LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 19741972

MAY AND BAKER LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 94051991

SIGMA ALDRICH IRELAND LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 118881996

WANBURY LTDInactivePROMETHAZINE HYDROCHLORIDE

DMF 181732005

IPCA LABORATORIES LTDInactivePROMETHAZINE HYDROCHLORIDE USP

DMF 272412013

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Nov 15, 2004	SUPPL -30	View Letter (PDF)
Dec 26, 2002	SUPPL -25	View Letter (PDF)
Dec 26, 2002	SUPPL -28	View Letter (PDF)
Dec 26, 2002	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — 12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

#004 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982