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Last Updated: August 9, 2020

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Mannitol - Generic Drug Details

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

Mannitol is the generic ingredient in twenty-five branded drugs marketed by B Braun, Hospira, Miles, Icu Medical Inc, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, Watson Labs, Baxter Hlthcare, and Pharmaxis Ltd, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mannitol. Eight suppliers are listed for this compound.

Drug Prices for mannitol

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Recent Clinical Trials for mannitol

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

SponsorPhase
Centre Hospitalier Universitaire de BesanconPhase 3
Brigham and Women's HospitalPhase 2/Phase 3
Raphael HeinzerPhase 2/Phase 3

See all mannitol clinical trials

Pharmacology for mannitol
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Medical Subject Heading (MeSH) Categories for mannitol

US Patents and Regulatory Information for mannitol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
B Braun MANNITOL 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-001 Jul 26, 1993 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira MANNITOL 10% mannitol INJECTABLE;INJECTION 016269-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
B Braun MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-002 Jul 26, 1993 AP RX No No   Start Trial   Start Trial   Start Trial
Hospira MANNITOL 25% mannitol INJECTABLE;INJECTION 016269-005 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Merck MANNITOL 25% mannitol INJECTABLE;INJECTION 005620-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs MANNITOL 25% mannitol INJECTABLE;INJECTION 087460-001 Jun 27, 1983 DISCN 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:

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Dow

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