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Last Updated: April 23, 2024

Midodrine hydrochloride - Generic Drug Details

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What are the generic drug sources for midodrine hydrochloride and what is the scope of freedom to operate?

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.

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:	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

Recent Clinical Trials for midodrine hydrochloride

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

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

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
Rubicon	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	212543-003	Aug 19, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Pharms Inc	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076577-002	Sep 10, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	076514-001	Sep 11, 2003		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xiromed	MIDODRINE HYDROCHLORIDE	midodrine hydrochloride	TABLET;ORAL	207849-003	Oct 1, 2020	AB	RX	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

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