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, Cipla, Gland Pharma Ltd, Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Rubicon, Impel Pharms, and Novartis, and is included in fifteen 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:	15
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	48
Clinical Trials:	16
Patent Applications:	1,945
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

Anatomical Therapeutic Chemical (ATC) Classes for DIHYDROERGOTAMINE MESYLATE

N02CA	Ergot alkaloids
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

N02CA	Ergot alkaloids
N02C	ANTIMIGRAINE PREPARATIONS
N02	ANALGESICS
N	Nervous system

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
Hikma	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	211393-001	Feb 28, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	040453-001	Jun 9, 2003	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impel Pharms	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	⤷ Sign Up	⤷ Sign Up
Bausch	MIGRANAL	dihydroergotamine mesylate	SPRAY, METERED;NASAL	020148-001	Dec 8, 1997	⤷ Sign Up	⤷ Sign Up
>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	3341059	DISPOSITIF D'ADMINISTRATION NASALE EN LIGNE (IN-LINE NASAL DELIVERY DEVICE)	⤷ Sign Up
Israel	257845	התקן קווי למתן דרך האף (In-line nasal delivery device)	⤷ Sign Up
Russian Federation	2020125871	ИНТРАНАЗАЛЬНАЯ ДОСТАВКА ДИГИДРОЭРГОТАМИНА С ПОМОЩЬЮ ПРЕЦИЗИОННОГО УСТРОЙСТВА ДЛЯ ДОСТАВКИ В ОБОНЯТЕЛЬНУЮ ОБЛАСТЬ	⤷ Sign Up
Brazil	122021002471	Dispositivo de distribuição de droga nasal	⤷ Sign Up
Brazil	112013028572	bocais para entrega de droga nasal	⤷ Sign Up
China	111936140	通过精密鼻装置的双氢麦角胺的鼻内递送 (INTRANASAL DELIVERY OF DIHYDROERGOTAMINE BY PRECISION OLFACTORY DEVICE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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