Treats migraine headaches with or without aura. Sold as D.H.E. 45, Migranal, Trudhesa, Brekiya, Atzumi. Every FDA application for this active ingredient: 5 branded and 13 generic.
As of Nov 15, 2026, FDA lists 18 applications for Dihydroergotamine Mesylate (sold as D.H.E. 45, Migranal, Trudhesa and others), first approved Apr 12, 1946, with 0 new uses approved and 0 published complete response letters.
| Dihydroergotamine Mesylate | Part D | $9.7M | -58% | 2,751 |
| Trudhesa | Part D | $8.8M | +55% | 333 |
| Brekiya | Part D | $280K | New | 21 |
| Migranal | Part D | $146K | -84% | 20 |
| D.H.E.45 | Part B | $13K | +17% | 72 |
| AI-Supported Mobile High-Impact and Strengthening Exercise Program in Postmenopausal Women With Low Bone DensityOsteopenia · Istanbul University | Not applicable | Active, not recruiting | Nov 5, 2026 |
| Phase 1 Study Evaluating Safety and Pharmacokinetics of ASY202 in Adults With AsthmaSafety in Asthma Patients · Aspeya, Inc. | Phase 1 | Recruiting | Jun 24, 2026 |
| Study Evaluating the Efficacy, Safety, and Tolerability of ASY202 (Dihydroergotamine Mesylate [DHE] Inhalation Powder Delivered Via a Multidose Dry Powder Inhaler) for the Acute Treatment of Migraine in Adult PatientsMigraine · Aspeya, Inc. | Phase 2 | Recruiting | Jun 15, 2026 |
| Apr 12, 1946 | D.H.E. 45NDA 5929 | Bausch | 26 | Discontinued |
| Dec 8, 1997 | MigranalNDA 20148 · New dosage form | Bausch | 14 | Marketed |
| Apr 28, 2003 | Dihydroergotamine MesylateANDA 40475 | Padagis US | 1 | Discontinued |
| Jun 9, 2003 | Dihydroergotamine MesylateANDA 40453 | Hikma | 1 | Marketed |
| Sep 15, 2017 | Dihydroergotamine MesylateANDA 206621 | Hikma Pharms | 1 | Marketed |
| Jul 11, 2018 | Dihydroergotamine MesylateANDA 207264 | Sagent Pharms Inc | 1 | Marketed |
| Jan 7, 2020 | Dihydroergotamine MesylateANDA 212046 | Milla Pharms | 2 | Marketed |
| Feb 28, 2020 | Dihydroergotamine MesylateANDA 211393 | Hikma | 0 | Marketed |
| May 20, 2020 | Dihydroergotamine MesylateANDA 212907 | Cipla | 1 | Marketed |
| Sep 2, 2021 | TrudhesaNDA 213436 · New formulation or manufacturer | Impel Pharms | 0 | Marketed |
| Jan 4, 2022 | Dihydroergotamine MesylateANDA 214105 | Amneal | 1 | Discontinued |
| Jun 22, 2023 | Dihydroergotamine MesylateANDA 216881 | Rubicon Research | 0 | Marketed |
| Aug 18, 2023 | Dihydroergotamine MesylateANDA 215623 | Gland | 0 | Marketed |
| Sep 20, 2024 | Dihydroergotamine MesylateANDA 212334 | Cipla | 0 | Discontinued |
| Jan 7, 2025 | Dihydroergotamine MesylateANDA 216747 | Baxter Hlthcare Corp | 0 | Discontinued |
| Feb 26, 2025 | Dihydroergotamine MesylateANDA 215228 | Somerset Theraps LLC | 0 | Marketed |
| Apr 30, 2025 | AtzumiNDA 217901 · New dosage form | Satsuma Pharms | 0 | Marketed |
| May 14, 2025 | BrekiyaNDA 215400 · New formulation or manufacturer | Amneal | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma
Cipla
Baxter Hlthcare Corp