METHYLERGONOVINE MALEATE - Generic Drug Details

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What are the generic 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 Trupharma, 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. Thirteen 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
Edison Theraps Llc	METHERGINE	methylergonovine maleate	TABLET;ORAL	006035-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211455-001	Mar 20, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	091577-001	May 2, 2011	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	METHYLERGONOVINE MALEATE	methylergonovine maleate	INJECTABLE;INJECTION	090193-001	Nov 24, 2008	AP	RX	No	No	⤷ 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

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	42
Clinical Trials:	4
Patent Applications:	553
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