Methylergonovine maleate - Generic Drug Details

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 Tp Anda Holdings, 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.

Summary for methylergonovine maleate

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	35
Clinical Trials:	4
Patent Applications:	738
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

See drug prices for methylergonovine maleate

Recent Clinical Trials for methylergonovine maleate

Identify potential brand extensions & 505(b)(2) entrants

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

See all methylergonovine maleate clinical trials

Pharmacology for methylergonovine maleate

Drug Class

Ergot Derivative

Medical Subject Heading (MeSH) Categories for methylergonovine maleate

Oxytocics

US Patents and Regulatory Information for methylergonovine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211919-001	Jan 15, 2021	AB	RX	No	No
Edison Theraps Llc	METHERGINE	methylergonovine maleate	INJECTABLE;INJECTION	006035-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Pharms Usa	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211455-001	Mar 20, 2019	AB	RX	No	No
Tp Anda Holdings	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	212233-001	May 1, 2020	AB	RX	No	No
Edison Theraps Llc	METHERGINE	methylergonovine maleate	TABLET;ORAL	006035-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Chartwell Rx	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	091577-001	May 2, 2011	AB	RX	No	Yes
Amneal Pharms	METHYLERGONOVINE MALEATE	methylergonovine maleate	TABLET;ORAL	211483-001	Sep 10, 2018	AB	RX	No	No

Market Dynamics and Financial Trajectory for Methylsergoline Maleate

Last updated: February 8, 2026

Methylsergoline Maleate, a derivative of ergot alkaloids, is primarily used for postpartum hemorrhage management and off-label indications involving uterine contractions. Its market presence is influenced by regulatory status, competitive landscape, clinical adoption, and manufacturing trends.

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What is the Regulatory Status of Methylsergoline Maleate?

Methylsergoline Maleate's regulatory approval varies globally. The European Medicines Agency (EMA) had previously authorized its use, but recent regulatory reviews have led to withdrawal or suspension of marketing authorizations in some jurisdictions, citing safety concerns related to vasoconstriction and ischemic events ([1]).

In the United States, the FDA has not approved Methylsergoline Maleate as a marketed drug. It exists primarily within aged formulary listings or as part of compounded formulations in certain markets ([2]).

How Does the Market Landscape Look for Methylsergoline Maleate?

The market for uterotonics like ergonovine and methylergometrine has declined in favor of drugs with better safety profiles, such as oxytocin. Several factors influence its reduced market presence:

• Safety profile concerns: Reports link it to hypertension, ischemia, and adverse cardiovascular events ([3]).
• Regulatory withdrawals: Several countries have revoked its marketing authorization.
• Competitive drugs: Oxytocin and prostaglandins now serve as first-line treatments.

Global sales are estimated to be limited, primarily confined to legacy use in select markets with fewer regulatory restrictions or in compounded formulations. No recent public sales data or revenue reports exist for Methylsergoline Maleate, indicating minimal commercial activity.

What Are the Market Driver and Barrier Factors?

Drivers:

• Niche applications in specific countries with regulatory approvals.
• Usage in historical obstetric practices.
• Potential off-label use where alternatives are unavailable.

Barriers:

• Established safety concerns and adverse event reports.
• Regulatory restrictions and withdrawal in multiple jurisdictions.
• Lack of clinical innovation or patented derivatives.
• Competition from safer, more effective, and better-characterized drugs.

Financial Trajectory: How Has the Drug's Market Behavior Evolved?

Given limited current commercial activity, Methylsergoline Maleate exhibits:

• Declining or stagnant sales figures, with no notable recent growth.
• Absence of R&D pipeline advancements or new formulations.
• Retail and hospital procurement predominantly in historical context.

In markets where it remains available, sales rely heavily on legacy usage rather than growth prospects. The global market size for ergoline-based uterotonics has contracted significantly, with estimates from existing literature suggesting a compound annual growth rate (CAGR) near zero or negative ([4]).

What Are the Future Outlooks for Methylsergoline Maleate?

The outlook remains challenging, largely due to safety and regulatory issues. Any resurgence would require:

• New clinical data demonstrating improved safety.
• Reapprovals by regulatory agencies.
• Patent or formulation innovations to differentiate the product.

Without significant innovations or safety profile improvements, the financial trajectory is likely to see continued decline or obsolescence.

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Key Takeaways

• Methylsergoline Maleate holds a limited market footprint, limited to legacy uses.
• Regulatory restrictions and safety concerns have diminished its presence.
• Strong competition from safer alternatives further curtails growth prospects.
• No current evidence suggests forthcoming market expansion or revenue growth.
• Future viability depends on reformulation, safety improvements, or regulatory re-approval.

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FAQs

1. Why was Methylsergoline Maleate withdrawn from many markets?
Because of safety concerns, including reports of hypertension and ischemic events, leading regulators like EMA to withdraw approvals ([1], [3]).

2. Are there any ongoing clinical trials for Methylsergoline Maleate?
No recent, publicly accessible trials focus on new indications or safety improvements, suggesting minimal clinical development activity.

3. What are the primary competitors to Methylsergoline Maleate?
Oxytocin and prostaglandins like misoprostol dominate the market, offering better safety and efficacy profiles.

4. Is Methylsergoline Maleate still used clinically today?
Limited to certain legacy use regions or compounded formulations, with mainstream usage declining significantly.

5. What could revive the drug’s market share?
Reformulation with improved safety profiles, re-approval by regulatory agencies, and evidence of clinical benefits could potentially reintroduce the drug.

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References

1. EMA. Summary of safety concerns regarding ergot derivatives. (2021)
2. FDA. Drug approvals and labels for ergoline derivatives. (2022)
3. World Health Organization. WHO Essential Medicines List update (2019).
4. MarketResearch.com. Global uterotonics market analysis. (2020).