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Last Updated: October 22, 2021

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Mannitol - Generic Drug Details

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What are the generic sources for mannitol and what is the scope of patent protection?

Mannitol is the generic ingredient in twenty-six 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, Pharmaxis Ltd, and Chiesi, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for mannitol

See drug prices for mannitol

Recent Clinical Trials for mannitol

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

SponsorPhase
Rabin Medical CenterN/A
The Cleveland ClinicEarly Phase 1
McMaster UniversityPhase 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
Icu Medical Inc MANNITOL 5% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-001 Jan 8, 1987 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
B Braun MANNITOL 5% mannitol INJECTABLE;INJECTION 016080-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Icu Medical Inc MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-003 Jan 8, 1990 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Icu Medical Inc SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 018316-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Baxter Hlthcare OSMITROL 15% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-008 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Chiesi BRONCHITOL mannitol POWDER;INHALATION 202049-001 Oct 30, 2020 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Icu Medical Inc MANNITOL 10% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-002 Jan 8, 1987 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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:

Harvard Business School
Colorcon
McKinsey
Medtronic
Baxter
Merck

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