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Last Updated: September 23, 2020

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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 Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Impax Pharms, Mylan Pharms Inc, Par Pharm Inc, Rubicon, Unique Pharm Labs, Upsher Smith Labs, and Takeda Pharms Usa, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are thirteen drug master file entries for midodrine hydrochloride. Seventeen suppliers are listed for this compound.

Recent Clinical Trials for MIDODRINE HYDROCHLORIDE

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

SponsorPhase
Bürgerspital SolothurnPhase 4
Institute of Health Economics, CanadaPhase 4
University of AlbertaPhase 4

See all MIDODRINE HYDROCHLORIDE clinical trials

Pharmacology for MIDODRINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for MIDODRINE HYDROCHLORIDE

US Patents and Regulatory Information for MIDODRINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Pharms MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076449-001 May 27, 2004 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell Rx MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076514-002 Sep 11, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Par Pharm Inc MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 207169-003 Oct 29, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076577-002 Sep 10, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 077746-002 Sep 12, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Takeda Pharms Usa PROAMATINE midodrine hydrochloride TABLET;ORAL 019815-002 Sep 6, 1996 DISCN Yes No   Start Trial   Start Trial   Start 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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