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INAPSINE

NDA

DROPERIDOL | N016796 | RISING PHARMA HOLDINGS INC

1 strength0 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

3 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Regulatory Affairs Consulting FDA-2025-P-0253 · 5 docket documents Robert van Osdel, a regulatory affairs consultant, filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine whether the reference listed drug Inapsine Injection 2.5 mg/mL (droperidol, N016796) was withdrawn from marketing for	505(q)	2025-01-17	Granted	Regulatory Affairs Consulting
Citizen Petition from Providence St. Peter Hospital / Centralia Hospital FDA-2022-P-2238 · 6 docket documents Providence St. Peter Hospital, represented by pharmacists including Julie McCoy, filed this citizen petition under 21 C.F.R. § 10.25(a) requesting that the FDA amend the boxed warning for droperidol by removing five sentences that address prescribing restrictions, QT prolongation risk statements, an	Other	2022-09-14	Withdrawn	Providence St. Peter Hospital / Centralia Hospital
Citizen Petition from Providence St. Peter Hospital/Centralia Hospital FDA-2022-P-1409 · 43 docket documents Providence St. Peter Hospital and Centralia Hospital, represented by Julie McCoy and other pharmacists, filed this citizen petition under 21 C.F.R. § 10.25(a) requesting that the FDA amend the boxed warning for droperidol by removing five sentences that the petitioners argue are redundant, overly pr	Other	2022-07-01	Denied	Providence St. Peter Hospital/Centralia Hospital

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

Clinical Trials

17 trials from ClinicalTrials.gov, 12 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Antagonism Research Between Antiemetics Agents and Acetaminophen in Thyroidectomy's Post-operative Analgesia.NCT01679093	Phase 3	Completed	University Hospital, Lille	66	2009-06 → 2011-06
Postoperative Vomiting in Children: Comparison Tri - Versus bi -Prophylaxis NCT01739985	N/A	Completed	Assistance Publique - Hôpitaux de Paris	322	2010-12 → 2014-05
Prophylaxis of Postoperative Nausea and Vomiting After Cardiac Surgery NCT02744495	Phase 3	Completed	Hôpital Privé de Parly II - Le Chesnay	502	2016-02 → 2016-12
Akathisia in Post Operative Outpatients Surgery NCT01942343	Phase 3	Completed	University Hospital, Strasbourg, France	300	2013-10 → 2015-10
Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children NCT01434017	Phase 4	Completed	Centre Hospitalier Universitaire Vaudois	300	2008-11 → 2013-06
Gender Influence on Torsadogenic Actions of Droperidol.NCT03944681	N/A	Completed	Medical University of Gdansk	50	2019-04-23 → 2020-12-31
Drug Interactions Between Paracetamol and Setrons in Pain Management NCT01432977	Phase 3	Completed	University Hospital, Limoges	72	2011-09 → 2012-06
The Effects of the Anti Nausea Drugs Droperidol and Ondansetron on the Way the Heart Recovers Between Beats NCT00624208	N/A	Completed	University of British Columbia	80	2008-02 → 2009-08
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis NCT02625181	N/A	Completed	Vanderbilt University	27,034	2016-07 → 2017-11-30
Role of Droperidol in Postoperative Vomiting NCT00702442	Phase 4	Completed	Aristotle University Of Thessaloniki	100	2008-06 → 2011-07

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

Medicare Part D Spending

CMS annual spending data for Droperidol (2024)

Total Spending

$987.17

Total Claims

Beneficiaries

Avg Cost/Unit

$4.29

Spending Trend

$3K(2023)→$987.17(2024)

YoY Change:-2.9%

5yr CAGR:-2.9%

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

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

JOINT STOCK CO GRINDEKSDROPERIDOL USP

DMF 229752009

MEHTA API PVT LTDDROPERIDOL USP

DMF 421102025

JANSSEN PHARMACEUTICA NVInactiveDROPERIDOL,CODE#R4749,MNFG IN BELGIUM AND PUERTO RICO FACILITIES

DMF 48901983

NV ORGANONInactiveDROPERIDOL

DMF 57731985

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveDROPERIDOL

DMF 75391988

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveDROPERIDOL USP, NON-STERILE BULK DRUG INTENDED FOR HUMAN USE

DMF 138971998

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 16, 2003	SUPPL -39	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.