MIDODRINE HYDROCHLORIDE Drug Patent Profile

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Midodrine Hydrochloride is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Endo Operations, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Rubicon, Thinq Pharm-cro Pvt, Xiromed, and Zydus Lifesciences. and is included in thirteen NDAs.

The generic ingredient in MIDODRINE HYDROCHLORIDE is midodrine hydrochloride. There are thirteen drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the midodrine hydrochloride profile page.

A generic version of MIDODRINE HYDROCHLORIDE was approved as midodrine hydrochloride by MYLAN PHARMS INC on September 10^th, 2003.

US Patents:	0
Applicants:	13
NDAs:	13
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	100
Patent Applications:	285
DailyMed Link:	MIDODRINE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Noha Mansour	Phase 4
Henan Provincial People's Hospital	N/A
First Affiliated Hospital Xi'an Jiaotong University	N/A

Drug Class	alpha-Adrenergic Agonist
Mechanism of Action	Adrenergic alpha-Agonists

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thinq Pharm-cro Pvt	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207613-002	Nov 2, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-001	Aug 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Thinq Pharm-cro Pvt	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207613-003	Nov 2, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-002	Aug 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734-001	Jan 21, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Pharms	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076449-003	Dec 16, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076577-003	Sep 10, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration