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, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Cipla, Impel Pharms, and Novartis, and is included in twelve NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dihydroergotamine mesylate has sixty-one patent family members in fifteen countries.

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

Summary for dihydroergotamine mesylate

International Patents:	61
US Patents:	6
Tradenames:	5
Applicants:	10
NDAs:	12
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	47
Clinical Trials:	16
Patent Applications:	2,536
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
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Cipla	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	212907-001	May 20, 2020	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Bausch	D.H.E. 45	dihydroergotamine mesylate	INJECTABLE;INJECTION	005929-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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	See Plans and Pricing	See Plans and Pricing
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	See Plans and Pricing	See Plans and Pricing
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	See Plans and Pricing	See Plans and Pricing
>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
European Patent Office	3679971	DISPOSITIF D'ADMINISTRATION DE MÉDICAMENT PAR VOIE NASALE (NASAL DRUG DELIVERY DEVICE)	See Plans and Pricing
Russian Federation	2741249	НАКОНЕЧНИКИ ДЛЯ НАЗАЛЬНОЙ ДОСТАВКИ ЛЕКАРСТВЕННЫХ СРЕДСТВ (TIPS FOR NASAL DRUG DELIVERY)	See Plans and Pricing
New Zealand	741171	In-line nasal delivery device	See Plans and Pricing
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.