Is there a generic for Methylergonovine maleate?

Yes. The FDA Orange Book lists 8 approved generic (ANDA) applications for Methylergonovine maleate, referencing the brand METHERGINE. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Methylergonovine maleate?

METHERGINE (NDA 006035, EDISON THERAPS LLC) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Methylergonovine maleate are approved?

Methylergonovine maleate is approved in the following dosage forms: injectable, tablet.

FDA Orange Book · active-ingredient family

Methylergonovine maleate

Methylergonovine maleate: 1 brand, 8 generics; first approved Nov 24, 2008; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available — 8 ANDA applications approved.

Brands (NDA)

Generics (ANDA)

Listed patents

Presentations

Originator applications

Brand (NDA) products

METHERGINERLD

EDISON THERAPS LLCNDA 006035—2 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET	ORAL	Discontinued	—
0.2MG/ML	INJECTABLE	INJECTION	Discontinued	—

Abbreviated applications

Generic (ANDA) products (8)

METHYLERGONOVINE MALEATE

RISINGANDA 2119192021

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATE

TP ANDA HOLDINGSANDA 2122332020

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATE

TEVA PHARMS USAANDA 2114552019

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATE

AMNEAL PHARMSANDA 2114832018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATE

GRANULESANDA 2104242018

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATERS

CHARTWELL RXANDA 0915772011

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

METHYLERGONOVINE MALEATE

BRECKENRIDGEANDA 0408892010

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/ML	INJECTABLE	INJECTION	Rx	AP

METHYLERGONOVINE MALEATERS

AM REGENTANDA 0901932008

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG/ML	INJECTABLE	INJECTION	Rx	AP

Orange Book patent file

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

FDA approval span

Approval history

First approval

Nov 24, 2008

17 yr 11 mo ago

Most recent approval

Jan 15, 2021

5 yr 7 mo ago

Approvals span 2008–2021 across 9 FDA applications.

Brand (NDA) 111%

Generic (ANDA) 889%

Methylergonovine maleate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo