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-seven suppliers are listed for this compound.

Summary for MIDODRINE HYDROCHLORIDE

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

Recent Clinical Trials for MIDODRINE HYDROCHLORIDE

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

Sponsor	Phase
Noha Mansour	Phase 4
Fuwai Yunnan Cardiovascular Hospital	N/A
Beijing Chao Yang Hospital	N/A

See all MIDODRINE HYDROCHLORIDE clinical trials

Pharmacology for MIDODRINE HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for MIDODRINE HYDROCHLORIDE

Adrenergic alpha-1 Receptor Agonists
Sympathomimetics
Vasoconstrictor Agents

Anatomical Therapeutic Chemical (ATC) Classes for MIDODRINE HYDROCHLORIDE

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

US Patents and Regulatory Information for MIDODRINE HYDROCHLORIDE

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Glossary

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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
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	076577-003	Sep 10, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Upsher Smith Labs	ORVATEN	midodrine hydrochloride	TABLET;ORAL	076725-002	Nov 3, 2004	AB	RX	No	Yes	⤷ 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

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