DIHYDROERGOTAMINE MESYLATE Drug Patent Profile

When do Dihydroergotamine Mesylate patents expire, and what generic alternatives are available?

Dihydroergotamine Mesylate is a drug marketed by Hikma, Hikma Pharms, Padagis Us, Provepharm Sas, Sagent Pharms Inc, Amneal, Cipla, and Custopharm Inc. and is included in eight NDAs.

The generic ingredient in DIHYDROERGOTAMINE MESYLATE is dihydroergotamine mesylate. There are six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the dihydroergotamine mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dihydroergotamine Mesylate

A generic version of DIHYDROERGOTAMINE MESYLATE was approved as dihydroergotamine mesylate by PADAGIS US on April 28^th, 2003.

Summary for DIHYDROERGOTAMINE MESYLATE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	54
Clinical Trials:	16
Patent Applications:	1,575
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information 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
Hikma	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	040453-001	Jun 9, 2003	AP	RX	No	No
Cipla	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	212907-001	May 20, 2020	AB	RX	No	No
Provepharm Sas	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	212046-001	Jan 7, 2020	AP	RX	No	No
Custopharm Inc	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	211393-001	Feb 28, 2020	AB	RX	No	No
Hikma Pharms	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	206621-001	Sep 15, 2017	AP	RX	No	Yes
Padagis Us	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	INJECTABLE;INJECTION	040475-001	Apr 28, 2003	AP	RX	No	No
Amneal	DIHYDROERGOTAMINE MESYLATE	dihydroergotamine mesylate	SPRAY, METERED;NASAL	214105-001	Jan 4, 2022		DISCN	No	No