Methylergonovine maleate - Generic Drug Details

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What are the generic drug sources for methylergonovine maleate and what is the scope of freedom to operate?

Methylergonovine maleate is the generic ingredient in two branded drugs marketed by Edison Theraps Llc, Am Regent, Breckenridge, Amneal Pharms, Chartwell Rx, Granules, Rising, Teva Pharms Usa, and Tulex Pharms Inc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for methylergonovine maleate. Twelve suppliers are listed for this compound.

Sponsor	Phase
Johns Hopkins University	Early Phase 1
Brigham and Women's Hospital	Phase 4
University of California, San Francisco	Phase 4

Sponsor

Phase

Johns Hopkins University

Early Phase 1

Brigham and Women's Hospital

Phase 4

University of California, San Francisco

Phase 4

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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
Amneal Pharms	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211483-001	Sep 10, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Edison Theraps Llc	METHERGINE	methylergonovine maleate	TABLET;ORAL	006035-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Tulex Pharms Inc	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	212233-001	May 1, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	091577-001	May 2, 2011	AB	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granules	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	210424-001	May 15, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ 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

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	4
Patent Applications:	553
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for methylergonovine maleate
What excipients (inactive ingredients) are in methylergonovine maleate?	methylergonovine maleate excipients list
DailyMed Link:	methylergonovine maleate at DailyMed