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METHERGINE

NDA

METHYLERGONOVINE MALEATE | N006035 | EDISON THERAPEUTICS LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Gland Pharma Limited FDA-2025-P-6392 Gland Pharma Limited filed this citizen petition requesting that the FDA determine whether Methergine (methylergonovine maleate) Injection, 0.2 mg/mL (NDA #006035), held by Edison Therapeutics LLC, was voluntarily withdrawn from sale for reasons of safety or effectiveness. The determination is neces	505(q)	2025-11-21	Withdrawn	Gland Pharma Limited

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Methylergonovine Maleate* (2023)

Total Spending

$540K

Total Claims

197

Beneficiaries

Avg Cost/Unit

$27.13

Spending Trend

$835K(2019)→$893K(2020)→$681K(2021)→$608K(2022)→$540K(2023)

YoY Change:+6.5%

5yr CAGR:-8.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain2 active DMFs

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

TAPI NL BVMETHYLERGONOVINE MALEATE USP

DMF 189882005

ZHEJIANG BOXIAO BIOPHARMACEUTICAL CO LTDMETHYLERGONOVINE MALEATE (NON-STERILE, ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 403432024

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
May 30, 2025	SUPPL -80	View Letter (PDF)
Jun 27, 2012	SUPPL -78	View Letter (PDF)
May 1, 2007	SUPPL -75	View Letter (PDF)
Mar 2, 2004	SUPPL -72	View Letter (PDF)
Oct 9, 2003	SUPPL -73	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#003 — 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#004 — 0.2MG/ML

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982