Viewing data from:

MIGRANAL

NDA

DIHYDROERGOTAMINE MESYLATE | N020148 | 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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Migranal (2023)

Total Spending

$552K

Total Claims

112

Beneficiaries

Avg Cost/Unit

$513.38

Spending Trend

$2.1M(2019)→$1.3M(2020)→$608K(2021)→$486K(2022)→$552K(2023)

YoY Change:+4.8%

5yr CAGR:+1.9%

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

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

4 letters from Drugs@FDA

Date	Submission	Document
May 10, 2022	SUPPL -26	View Letter (PDF)
Aug 2, 2019	SUPPL -25	View Letter (PDF)
Jul 31, 2002	SUPPL -7	View Letter (PDF)
Jul 31, 2002	SUPPL -8	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/SPRAY

RLDAB

0 patents0 exclusivities▴

SPRAY, METERED;NASAL | Approved: Dec 8, 1997

No patent or exclusivity listings for this strength.