MIDODRINE HYDROCHLORIDE Drug Patent Profile

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Midodrine Hydrochloride is a drug marketed by Alembic, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Par Pharm Inc, Rubicon, Thinq Pharm-cro Pvt, Xiromed, and Zydus. 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-seven 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:	26
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	99
Patent Applications:	285
Formulation / Manufacturing:	see details
DailyMed Link:	MIDODRINE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Noha Mansour	Phase 4
Ningbo No. 1 Hospital	N/A
First Affiliated Hospital, Sun Yat-Sen 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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-001	Aug 19, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Thinq Pharm-cro Pvt	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207613-003	Nov 2, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-002	Aug 19, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alembic	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	214734-001	Jan 21, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mankind Pharma	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	217271-003	Nov 1, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration