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Last Updated: March 19, 2024

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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-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, Arna Pharma, 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

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

SponsorPhase
University Hospital Inselspital, BerneEarly Phase 1
Ecole Polytechnique Fédérale de LausanneEarly Phase 1
Centre Hospitalier Universitaire VaudoisEarly Phase 1

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
Baxter Hlthcare OSMITROL 5% IN WATER mannitol INJECTABLE;INJECTION 013684-001 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs MANNITOL 25% mannitol INJECTABLE;INJECTION 087460-001 Jun 27, 1983 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Icu Medical Inc SORBITOL-MANNITOL IN PLASTIC CONTAINER mannitol; sorbitol SOLUTION;IRRIGATION 018316-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-003 Jul 26, 1993 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Miles MANNITOL 15% mannitol INJECTABLE;INJECTION 016472-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.