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PROAMATINE

NDA

MIDODRINE HYDROCHLORIDE | N019815 | TAKEDA PHARMACEUTICALS USA INC

3 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

4 petitions (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2024-P-5330 · 8 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, submitted a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Midodrine HCl Powder for Oral Solution in 2.5 mg, 5 mg, and 10 mg per packet strengths suitable for submissio	Suitability	2024-11-14	Granted	Hyman, Phelps & McNamara, P.C.
Citizen Petition from ALEMBIC PHARMACEUTICALS LIMITED FDA-2019-P-2370 · 4 docket documents Alembic Pharmaceuticals Limited filed this petition pursuant to 505(j)(7) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine the discontinuation of the Reference Listed Drug Proamtine (Midodrine Hydrochloride Tablets, NDA #019815) was not for safety or effectiveness reason	Other	2019-05-23	Granted	ALEMBIC PHARMACEUTICALS LIMITED
Suitability Petition from Haynes and Boone, LLP FDA-2018-P-1698 · 7 docket documents Haynes and Boone, LLP filed this citizen petition under Section 505(j)(2)(C) requesting that the FDA determine Midodrine Hydrochloride Oral Solution, 2.5 mg/5 ml, is suitable for submission in an ANDA, with Mylan's Midodrine Hydrochloride Oral Tablets, 5 mg, as the reference listed drug. The petitio	Suitability	2018-05-02	Open	Haynes and Boone, LLP
Custo Pharm Inc - Citizen Petiton FDA-2013-P-0027 · 4 docket documents Custo Pharm Inc filed this citizen petition requesting that the FDA amend the Orange Book to designate Impax Pharmaceutical's Midodrine Hydrochloride Tablets, ANDA 076449, as the reference listed drug for midodrine hydrochloride tablets 5 mg, since the previous reference listed drug Proamatine (NDA	505(q)	2013-01-03	Withdrawn	—

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

Clinical Trials

52 trials from ClinicalTrials.gov — 1 recruiting, 1 active, 37 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Orthostatic Intolerance NCT00262470	Phase 1/2	Active	Satish R. Raj	150	1997-04 → 2029-12
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure NCT02897063	Phase 1	Recruiting	Vanderbilt University Medical Center	34	2016-09 → 2026-12
Norepinephrine Infusion Versus Midodrine & Octreotide in Patients With Hepatorenal Syndrome Type 1.NCT03455322	Phase 4	Completed	National Hepatology & Tropical Medicine Research Institute	60	2018-08-15 → 2020-07-10
A Dose Response Trial Using 5 and 10 Mg of Midodrine Hydrochloride NCT00426842	Phase 2	Completed	James J. Peters Veterans Affairs Medical Center	11	2007-01 → 2011-03
Fasting Study of Midodrine HCl Tablets 5 mg and ProAmatine® Tablets 5 mg NCT00650364	Phase 1	Completed	Mylan Pharmaceuticals Inc	38	2002-08 → 2002-09
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure NCT02429557	Phase 1	Completed	Vanderbilt University Medical Center	21	2015-04 → 2025-12-31
A Study for Patients With Neurogenic Orthostatic Hypotension NCT00046475	Phase 4	Completed	Shire	140	1997-12-01 → 1999-11-24
Efficacy of Combination of Midodrine With Propranolol in Preventing First Bleed in Decompensated Cirrhotics With Severe Ascites.NCT04208776	N/A	Completed	Institute of Liver and Biliary Sciences, India	140	2020-02-04 → 2021-12-31
Midodrine in Hepatopulmonary Syndrome NCT03600870	Phase 1	Completed	Mayo Clinic	10	2018-08-02 → 2020-12-01
Clinical Efficacy of Midodrine in Symptomatic Orthostatic Hypotension NCT01515865	Phase 4	Completed	Shire	98	2012-05-23 → 2013-11-11

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

API Supply Chain14 active DMFs3 inactive

14 active API suppliers hold Drug Master Files for this ingredient.

EDMOND PHARMA SRLMIDODRINE HYDROCHLORIDE

DMF 160172002

INDUSTRIALE CHIMICA SRLMIDODRINE HYDROCHLORIDE

DMF 160062002

TAPI NL BVMIDODRINE HYDROCHLORIDE, NON-STERILE, BULK DRUG SUBSTANCE

DMF 161352002

STERLING WISCONSIN LLCMIDODRINE HYDROCHLORIDE USP

DMF 164812003

APOTEX INCMIDODRINE HYDROCHLORIDE USP

DMF 184702005

IPCA LABORATORIES LTDMIDODRINE HYDROCHLORIDE USP

DMF 274642013

PH HEALTH LTDMIDODRINE HYDROCHLORIDE USP

DMF 282112014

TIANJIN WEIJIE PHARMACEUTICAL CO LTDMIDODRINE HYDROCHLORIDE BULK DRUG SUBSTANCE

DMF 302162016

ENALTEC LABS PRIVATE LTDMIDODRINE HYDROCHLORIDE USP

DMF 308062016

EMCURE PHARMACEUTICALS LTDMIDODRINE HYDROCHLORIDE USP

DMF 309902016

OPTIMUS DRUGS PRIVATE LTDMIDODRINE HYDROCHLORIDE

DMF 362722021

ZYDUS LIFESCIENCES LTDMIDODRINE HYDROCHLORIDE USP

DMF 378652022

DASAMI LAB PRIVATE LTDMIDODRINE HYDROCHLORIDE USP

DMF 398852024

MANKIND PHARMA LTDMIDODRINE HYDROCHLORIDE USP

DMF 404082024

NYCOMED AUSTRIA GMBHInactiveMIDODRINE HYDROCHLORIDE

DMF 63151986

CADILA HEALTHCARE LTDInactiveMIDODRINE HYDROCHLORIDE

DMF 156102001

CHEMAGIS LTDInactiveMIDODRINE HYDROCHLORIDE

DMF 164172003

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2017	SUPPL -10	View Letter (PDF)
Jul 28, 2004	SUPPL -7	View Letter (PDF)
Mar 20, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 6, 1996

No patent or exclusivity listings for this strength.

#002 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Sep 6, 1996

#003 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 20, 2002