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SUPRANE

NDA

DESFLURANE | N020118 | BAXTER HEALTHCARE CORP

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
Baxter Healthcare Corporation, et al., (King & Spalding LLP) - Citizen Petition FDA-2011-P-0127 Baxter Healthcare Corporation, Baxter International Inc., and Baxter Healthcare SA filed this citizen petition under section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA confirm it will stay approval of ANDA 90-363 for 30 months from June 23, 2009, when Baxter received	505(q) Stay Request	2011-03-21	Partially Denied	—

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

Clinical Trials

1 trial from ClinicalTrials.gov, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
ANI-Guided Anesthetic Desflurane Consumption NCT06982209	N/A	Completed	Wonkwang University Hospital	125	2024-02-05 → 2025-04-30

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

API Supply Chain3 active DMFs

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

PIRAMAL CRITICAL CARE INCDESFLURANE USP

DMF 211112007

BLUE ZONE TECHNOLOGIES LTDDESFLURANE USP

DMF 257482012

HEBEI YIPIN PHARMACEUTICAL CO LTDDESFLURANE

DMF 421482025

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Nov 2, 2022	SUPPL -26	View Letter (PDF)
May 2, 2017	SUPPL -24	View Letter (PDF)
Nov 8, 2016	SUPPL -21	View Letter (PDF)
Feb 27, 2015	SUPPL -20	View Letter (PDF)
Sep 24, 2013	SUPPL -18	View Letter (PDF)
Apr 8, 2010	SUPPL -17	View Letter (PDF)
Apr 20, 2009	SUPPL -16	View Letter (PDF)
Dec 28, 2006	SUPPL -12	View Letter (PDF)
Aug 21, 2006	SUPPL -11	View Letter (PDF)
May 16, 2006	SUPPL -10	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100%

RLDAN

0 patents0 exclusivities▴

LIQUID;INHALATION | Approved: Sep 18, 1992

No patent or exclusivity listings for this strength.