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Last Updated: February 3, 2023

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

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Recent Clinical Trials for mannitol

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SponsorPhase
Genentech, Inc.Phase 1/Phase 2
Calm Water Therapeutics LLCN/A
Andover Research Eye InstituteN/A

See all mannitol clinical trials

Pharmacology for mannitol
Drug Class Osmotic Diuretic
Mechanism of Action Osmotic 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 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-004 Jul 26, 1993 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hospira SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 017636-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Igi Labs Inc MANNITOL 25% mannitol INJECTABLE;INJECTION 089239-001 May 6, 1987 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Miles MANNITOL 20% mannitol INJECTABLE;INJECTION 016472-004 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
B Braun MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% mannitol INJECTABLE;INJECTION 016080-007 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
B Braun MANNITOL 5% mannitol INJECTABLE;INJECTION 016080-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Intl Medication MANNITOL 25% mannitol INJECTABLE;INJECTION 083051-001 Approved Prior to Jan 1, 1982 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for mannitol

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pharmaxis Europe Limited Bronchitol mannitol EMEA/H/C/001252
Bronchitol is indicated for the treatment of cystic fibrosis (CF) in adults aged 18 years and above as an add-on therapy to best standard of care.
Authorised no no no 2012-04-13
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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