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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With Asthma NCT07665892	Phase 1	Recruiting	Aspeya, Inc.	40	2026-05-26 → 2026-12

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

Medicare Part D Spending

CMS annual spending data for Dihydroergotamine Mesylate* (2023)

Total Spending

$35.5M

Total Claims

17,337

Beneficiaries

3,239

Avg Cost/Unit

$238.59

Spending Trend

$38.5M(2019)→$46.4M(2020)→$43.5M(2021)→$37.2M(2022)→$35.5M(2023)

YoY Change:-5.3%

5yr CAGR:-7.1%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for D.H.E.45 (2023)

Total Spending

$15K

Total Claims

290

Beneficiaries

142

ASP Price

—

HCPCS: J1110 — Injection, dihydroergotamine mesylate, per 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

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#001 — 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.