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Last Updated: April 26, 2024

DIHYDROERGOTAMINE MESYLATE - Generic Drug Details

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What are the generic sources for dihydroergotamine mesylate and what is the scope of freedom to operate?

Dihydroergotamine mesylate is the generic ingredient in five branded drugs marketed by Bausch, Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Cipla, Rubicon, Jn Bidco, and Novartis, and is included in fourteen NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dihydroergotamine mesylate has sixty-four patent family members in sixteen countries.

There are six drug master file entries for dihydroergotamine mesylate. Ten suppliers are listed for this compound.

Summary for DIHYDROERGOTAMINE MESYLATE

International Patents:	64
US Patents:	6
Tradenames:	5
Applicants:	12
NDAs:	14
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	16
Patent Applications:	1,945
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for DIHYDROERGOTAMINE MESYLATE
What excipients (inactive ingredients) are in DIHYDROERGOTAMINE MESYLATE?	DIHYDROERGOTAMINE MESYLATE excipients list
DailyMed Link:	DIHYDROERGOTAMINE MESYLATE at DailyMed

See drug prices for DIHYDROERGOTAMINE MESYLATE

Recent Clinical Trials for DIHYDROERGOTAMINE MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Ache Laboratorios Farmaceuticos S.A.	Phase 3
Xijing Hospital	Phase 2/Phase 3
Satsuma Pharmaceuticals, Inc.	Phase 3

See all DIHYDROERGOTAMINE MESYLATE clinical trials

Pharmacology for DIHYDROERGOTAMINE MESYLATE

Drug Class	Ergotamine Derivative

Medical Subject Heading (MeSH) Categories for DIHYDROERGOTAMINE MESYLATE

Analgesics, Non-Narcotic
Dopamine Agonists
Vasoconstrictor Agents

US Patents and Regulatory Information for DIHYDROERGOTAMINE MESYLATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	D.H.E. 45	dihydroergotamine mesylate	INJECTABLE;INJECTION	005929-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	EMBOLEX	dihydroergotamine mesylate; heparin sodium; lidocaine hydrochloride	INJECTABLE;INJECTION	018885-001	Nov 30, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Jn Bidco	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Jn Bidco	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Jn Bidco	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for DIHYDROERGOTAMINE MESYLATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	⤷ Try a Trial	⤷ Try a Trial
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for DIHYDROERGOTAMINE MESYLATE

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2017105845	УСТРОЙСТВО ДЛЯ НАЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ	⤷ Try a Trial
South Korea	20180052662	인-라인 코 전달 장치	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2019136291		⤷ Try a Trial
European Patent Office	3851142	BUSES POUR L'ADMINISTRATION DE MÉDICAMENTS PAR VOIE NASALE (NOZZLES FOR NASAL DRUG DELIVERY)	⤷ Try a Trial
China	108601916	直列式鼻部递送装置 (IN-LINE NASAL DELIVERY DEVICE)	⤷ Try a Trial
European Patent Office	3341059	DISPOSITIF D'ADMINISTRATION NASALE EN LIGNE (IN-LINE NASAL DELIVERY DEVICE)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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