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Last Updated: August 9, 2020

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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 Apotex, Chartwell Rx, Impax Pharms, Mylan Pharms Inc, Par Pharm Inc, Rubicon, Unique Pharm Labs, Upsher Smith Labs, and Shire Llc, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for midodrine hydrochloride

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

SponsorPhase
Bürgerspital SolothurnPhase 4
Mansoura UniversityN/A
University of California, Los AngelesEarly Phase 1

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
Apotex MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 077746-002 Sep 12, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell Rx MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 076514-001 Sep 11, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Unique Pharm Labs MIDODRINE HYDROCHLORIDE midodrine hydrochloride TABLET;ORAL 207613-003 Nov 2, 2018 AB RX No 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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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Harvard Business School
Express Scripts
Boehringer Ingelheim
Baxter

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