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ULTANE

NDA

SEVOFLURANE | N020478 | ABBVIE 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

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Emprise Pharma LLC on behalf of Shandong New Time P... FDA-2026-P-3840 · 9 docket documents Emprise Pharma LLC, on behalf of Shandong New Time Pharmaceutical Co., Ltd., submitted a suitability petition under section 505(j)(2)(C) requesting approval to add a 100 mL bottle presentation to ANDA 214382 for Sevoflurane Inhalation Liquid, which is currently approved only in 250 mL, citing the re	Suitability	2026-04-10	Denied	Shandong New Time Pharmaceutical Co., Ltd

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

Clinical Trials

270 trials from ClinicalTrials.gov — 2 recruiting, 3 active, 181 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Compare the Long-term Outcomes After Two Different Anaesthetics NCT03089905	Phase 3	Active	Murdoch Childrens Research Institute	450	2017-08-10 → 2026-06
Association Between Anesthetic Drugs for General Anesthesia and Postoperative Intelligence/behavioral Assessment Results in Children NCT04364945	N/A	Active	Seoul National University Hospital	400	2020-06-17 → 2028-12-30
Anesthesia and Cancer Study: Colon Cancer NCT04259398	N/A	Active	Seoul National University Hospital	797	2020-02-18 → 2028-05-03
Sevoflurane Sedation in Patients With Septic Shock NCT03643367	Phase 2	Not Yet Recruiting	University of Zurich	153	2026-01 → 2027-11
Effects of Different Types of General Anesthesia on Postoperative Pupillary Reactivity NCT04307238	N/A	Recruiting	Medical University of Vienna	108	2020-03-09 → 2026-03-10
A Comparison of Emergence Agitation by Sevoflurane for Intraoperative Sedation Associated With Caudal Block NCT03134547	N/A	Completed	Yeungnam University College of Medicine	40	2016-06-01 → 2017-02-28
Power Spectral Analysis of EEG During Equi-MAC Inhalation Anesthesia NCT02872389	Phase 3	Completed	Kangbuk Samsung Hospital	90	2016-08-16 → 2016-12-06
Remimazolam Phase II Cardiac Anesthesia Study NCT01937767	Phase 2	Completed	Paion UK Ltd.	90	2013-08 → 2014-02-19
Assessment of the Anesthetic Effect on the Activity of Immune Cell in Patient With Breast Cancer NCT02567929	N/A	Completed	Konkuk University Medical Center	218	2016-03 → 2016-12
Recovery Profiles of Remifentanil-based Regimen for Cardiac Surgery NCT02712528	Phase 4	Completed	Konkuk University Medical Center	43	2015-05 → 2016-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$51.20

Highest Price

$58.79

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00074-4456-04ULTANE LIQUID,INHL	$58.79	FSS	Abbvie US LLC	07/31/2030
00074-4456-04ULTANE LIQUID,INHL	$51.20	Big4	Abbvie US LLC	07/31/2030

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

API Supply Chain6 active DMFs2 inactive

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

CENTRAL GLASS CO LTDSEVOFLURANE

DMF 111321994

SHANDONG NEW TIME PHARMACEUTICAL CO LTDSEVOFLURANE USP

DMF 227402009

JIANGSU HENGRUI PHARMACEUTICALS CO LTDSEVOFLURANE USP

DMF 305702016

BLUE-ZONE TECHNOLOGIES LTDSEVOFLURANE USP

DMF 388572023

HEBEI YIPIN PHARMACEUTICAL CO LTDSEVOFLURANE

DMF 421502025

SUPRIYA LIFESCIENCE LTDSEVOFLURANE USP

DMF 430482025

SHANDONG NEW TIME PHARMACEUTICAL CO LTDInactiveSEVOFLURANE (NON-STERILE BULK FORM)

DMF 190912005

JIANGSU HENGRUI MEDICINE CO LTDInactiveSEVOFLURANE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 249032011

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

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -35	View Letter (PDF)
Nov 2, 2022	SUPPL -34	View Letter (PDF)
May 20, 2022	SUPPL -32	View Letter (PDF)
Mar 2, 2022	SUPPL -24	View Letter (PDF)
Mar 2, 2022	SUPPL -23	View Letter (PDF)
Mar 2, 2022	SUPPL -28	View Letter (PDF)
Mar 2, 2022	SUPPL -27	View Letter (PDF)
Mar 13, 2014	SUPPL -26	View Letter (PDF)
Mar 13, 2014	SUPPL -25	View Letter (PDF)
Aug 17, 2012	SUPPL -19	View Letter (PDF)
Aug 17, 2012	SUPPL -20	View Letter (PDF)
Jan 28, 2010	SUPPL -18	View Letter (PDF)
Jul 3, 2006	SUPPL -16	View Letter (PDF)
Jun 23, 2005	SUPPL -13	View Letter (PDF)
Jun 29, 2004	SUPPL -7	View Letter (PDF)
Jul 6, 2003	SUPPL -12	View Letter (PDF)
Mar 30, 2001	SUPPL -6	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100%

RLDAN

0 patents0 exclusivities▴

LIQUID;INHALATION | Approved: Jun 7, 1995

No patent or exclusivity listings for this strength.