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Last Updated: December 13, 2019

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MANNITOL 10% Drug Profile

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Which patents cover Mannitol 10%, and what generic alternatives are available?

Mannitol 10% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in five NDAs.

The generic ingredient in MANNITOL 10% is mannitol. There are eighteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mannitol profile page.

Summary for MANNITOL 10%
Drug patent expirations by year for MANNITOL 10%
Recent Clinical Trials for MANNITOL 10%

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

SponsorPhase
Lund UniversityPhase 4
ALK-Abelló A/SPhase 4
University of CopenhagenPhase 4

See all MANNITOL 10% clinical trials

Pharmacology for MANNITOL 10%
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 10%

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 10% mannitol INJECTABLE;INJECTION 016080-002 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 10% mannitol INJECTABLE;INJECTION 016269-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Miles MANNITOL 10% mannitol INJECTABLE;INJECTION 016472-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
B Braun MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER mannitol INJECTABLE;INJECTION 016080-006 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Icu Medical Inc MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-002 Jan 8, 1987 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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