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PROVOCHOLINE

NDA

METHACHOLINE CHLORIDE | N019193 | METHAPHARM INC

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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive NCT06433921	Phase 1	Recruiting	GlaxoSmithKline	84	2024-08-14 → 2027-02-26

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part B Spending

CMS physician-administered drug spending for Provocholine (2023)

Total Spending

$53K

Total Claims

1,877

Beneficiaries

1,871

ASP Price

—

HCPCS: J7674 — Methacholine chloride administered as inhalation solution through a nebulizer, per 1 mg

Source: CMS Medicare Part B Spending by Drug (2023). Shows physician-administered drug costs.

API Supply Chain0 active DMFs1 inactive

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

APOTEX PHARMACHEM INCInactiveMETHACHOLINE CHLORIDE USP

DMF 117581995

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 100MG/VIAL

RLD

0 patents0 exclusivities▴

FOR SOLUTION;INHALATION | Approved: Oct 31, 1986

No patent or exclusivity listings for this strength.

#002 — 1600MG/VIAL

RLD

0 patents0 exclusivities▾

FOR SOLUTION;INHALATION | Approved: Aug 29, 2016