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D.H.E. 45

NDA

DIHYDROERGOTAMINE MESYLATE | N005929 | BAUSCH HEALTH US LLC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Baxter Healthcare Corporation FDA-2022-P-2842 · 5 docket documents Baxter Healthcare Corporation petitioned the FDA under 21 C.F.R. § 314.122 and § 314.161 to determine whether D.H.E 45 (dihydroergotamine mesylate) injection, USP 1 mg/mL, approved under NDA 005929, was withdrawn for reasons of safety or effectiveness. Baxter requested that the FDA formally determin	505(q)	2022-11-14	Granted	Baxter Healthcare Corporation

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

Clinical Trials

9 trials from ClinicalTrials.gov, 7 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity NCT00203268	N/A	Completed	Thomas Jefferson University	13	2003-12 → 2005-03
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine NCT00335777	Phase 4	Completed	Thomas Jefferson University	64	2006-08 → 2009-04
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine NCT03901482	Phase 3	Completed	Satsuma Pharmaceuticals, Inc.	1,201	2019-06-24 → 2020-08-13
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301)NCT03557333	Phase 3	Completed	Impel Pharmaceuticals	360	2018-07-13 → 2020-03-17
Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults NCT03401346	Phase 1	Completed	Impel Pharmaceuticals	36	2017-10-19 → 2017-12-06
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects NCT03874832	Phase 1	Completed	Satsuma Pharmaceuticals, Inc.	46	2018-09-11 → 2018-11-07
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure NCT01089062	Phase 1	Completed	Allergan	24	2010-03 → 2010-12
Cefalium® Compared to Tylenol® in the Treatment of Migraine Attacks NCT02582996	Phase 3	Suspended	Ache Laboratorios Farmaceuticos S.A.	336	2020-04 → 2021-06
Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine NCT03885154	Phase 2	Terminated	Kimberly S Jones	24	2017-10-03 → 2019-03-19

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

API Supply Chain4 active DMFs2 inactive

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

TAPI NL BVDIHYDROERGOTAMINE MESYLATE

DMF 149442000

CURIA ITALY SRLDIHYDROERGOTAMINE MESYLATE USP/EP

DMF 224072009

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 304972016

OLON SPADIHYDROERGOTAMINE MESYLATE

DMF 330222018

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveDIHYDROERGOTAMINE MESYLATE

DMF 102421993

LEK PHARMACEUTICALS DDInactiveDIHYDROERGOTAMINE MESYLATE

DMF 161942002

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 10, 2022	SUPPL -45	View Letter (PDF)
Jul 31, 2003	SUPPL -32	View Letter (PDF)
Jul 31, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1MG/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.