DIHYDROERGOTAMINE MESYLATE - Generic Drug Details

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland Pharma Ltd	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	215623-001	Aug 18, 2023	AP	RX	No	No
Rubicon	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	216881-001	Jun 22, 2023	AB	RX	No	No
Jn Bidco	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes			Y
Sagent Pharms Inc	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	207264-001	Jul 11, 2018	AP	RX	No	No
Padagis Us	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	040475-001	Apr 28, 2003	AP	RX	No	No
Jn Bidco	TRUDHESA	dihydroergotamine mesylate	SPRAY, METERED;NASAL	213436-001	Sep 2, 2021		RX	Yes	Yes
Provepharm Sas	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	212046-001	Jan 7, 2020	AP	RX	No	No

Expired US Patents for DIHYDROERGOTAMINE MESYLATE

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

International Patents for DIHYDROERGOTAMINE MESYLATE

Country	Patent Number	Title	Estimated Expiration
Japan	2017189676	鼻腔内投薬製剤用のノズル (NOZZLE FOR NASAL DRUG DELIVERY)
Japan	7317020
World Intellectual Property Organization (WIPO)	2012119153
World Intellectual Property Organization (WIPO)	2012154859
Brazil	122021002471	Dispositivo de distribuição de droga nasal
New Zealand	741171	In-line nasal delivery device
Hong Kong	1252257	在直線上的鼻腔輸送裝置 (IN-LINE NASAL DELIVERY DEVICE)