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-eight suppliers are listed for this compound.

Sponsor	Phase
Noha Mansour	Phase 4
RenJi Hospital	N/A
Fuwai Yunnan Cardiovascular Hospital	N/A

Sponsor

Phase

Noha Mansour

Phase 4

RenJi Hospital

N/A

Fuwai Yunnan Cardiovascular 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	076514-001	Sep 11, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	PROAMATINE	midodrine hydrochloride	TABLET;ORAL	019815-001	Sep 6, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-003	Nov 3, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212774-003	Aug 10, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	PROAMATINE	midodrine hydrochloride	TABLET;ORAL	019815-002	Sep 6, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	077746-003	Sep 12, 2006	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