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ERGOMAR

ANDA

ERGOTAMINE TARTRATE | A087693 | PANGEA PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-7182 Senores Pharmaceuticals, Inc. filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Ergotamine Tartrate Sublingual Tablets 1 mg, a lower strength formulation of the reference li	Suitability	2026-06-29	Open	Senores Pharmaceuticals

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

Medicare Part D Spending

CMS annual spending data for Ergomar (2023)

Total Spending

$41K

Total Claims

Beneficiaries

Avg Cost/Unit

$76.24

Spending Trend

$241K(2019)→$123K(2020)→$99K(2021)→$63K(2022)→$41K(2023)

YoY Change:+10.6%

5yr CAGR:+7.0%

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

API Supply Chain2 active DMFs4 inactive

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

CURIA ITALY SRLERGOTAMINE TARTRATE USP/EP

DMF 229322009

TAPI NL BVERGOTAMINE TARTRATE

DMF 247822011

IVAX PHARMACEUTICALS SROInactiveERGOTAMINE TARTRATE

DMF 30381977

FARMITALIA SPAInactiveERGOTAMINE TARTRATE USP

DMF 32101978

MEDIMPEX NORTH AMERICA INCInactiveERGOTAMINE TARTRATE

DMF 33581978

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveERGOTAMINE TARTRATE

DMF 57651985

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

Products (1)

#001 — 2MG

0 patents0 exclusivities▴

TABLET;SUBLINGUAL | Approved: Feb 24, 1983

No patent or exclusivity listings for this strength.