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, Endo Operations, Impax Pharms, Mankind Pharma, Mylan Pharms Inc, Novugen, Rubicon, Thinq Pharm-cro Pvt, Xiromed, Zydus Lifesciences, 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-eight suppliers are listed for this compound.

Sponsor	Phase
Noha Mansour	Phase 4
Yeditepe University Hospital	N/A
Henan Provincial People's Hospital	N/A

Sponsor

Phase

Noha Mansour

Phase 4

Yeditepe University Hospital

N/A

Henan Provincial People's 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
Chartwell Rx	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076514-002	Sep 11, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	213055-002	Sep 1, 2020	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
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-001	Aug 19, 2019	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

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	15
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	100
Patent Applications:	391
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