Midodrine hydrochloride - Generic Drug Details

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What are the generic drug 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-seven suppliers are listed for this compound.

Sponsor	Phase
Noha Mansour	Phase 4
Ningbo No. 1 Hospital	N/A
First Affiliated Hospital, Sun Yat-Sen University	N/A

Sponsor

Phase

Noha Mansour

Phase 4

Ningbo No. 1 Hospital

N/A

First Affiliated Hospital, Sun Yat-Sen University

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
Endo Operations	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207169-002	Oct 29, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Pharms	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076449-001	May 27, 2004	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
Zydus Lifesciences	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	213055-001	Sep 1, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076577-002	Sep 10, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-001	Nov 3, 2004	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:	27
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