MIDODRINE HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for midodrine hydrochloride and what is the scope of patent protection?

Midodrine hydrochloride is the generic ingredient in three branded drugs 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, Zydus, Upsher Smith Labs, and Takeda Pharms Usa, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for midodrine hydrochloride. Twenty-seven suppliers are listed for this compound.

Sponsor	Phase
Noha Mansour	Phase 4
First Affiliated Hospital, Sun Yat-Sen University	N/A
Yeditepe University Hospital	N/A

Sponsor

Phase

Noha Mansour

Phase 4

First Affiliated Hospital, Sun Yat-Sen University

N/A

Yeditepe University Hospital

N/A

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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
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
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-001	Nov 3, 2004	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Takeda Pharms Usa	PROAMATINE	midodrine hydrochloride	TABLET;ORAL	019815-003	Mar 20, 2002		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-002	Nov 3, 2004	AB	RX	No	Yes	⤷ 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
Chartwell Rx	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076514-003	Jul 2, 2004		DISCN	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

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	99
Patent Applications:	391
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in MIDODRINE HYDROCHLORIDE?	MIDODRINE HYDROCHLORIDE excipients list
DailyMed Link:	MIDODRINE HYDROCHLORIDE at DailyMed

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