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Mannitol - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for mannitol?

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

There are seventeen drug master file entries for mannitol. Seven suppliers are listed for this compound.

Summary for Generic Name: mannitol

Tradenames:25
Patents:1
Applicants:13
NDAs:21
Drug Master File Entries: see list17
Suppliers / Packagers: see list7
Bulk Api Vendors: see list79
Clinical Trials: see list61
Patent Applications: see list205,808
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mannitol at DailyMed

Pharmacology for Ingredient: mannitol

Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Igi Labs Inc
MANNITOL 25%
mannitol
INJECTABLE;INJECTION089240-001May 6, 1987DISCNNoNo► Subscribe► Subscribe
B Braun
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
mannitol
INJECTABLE;INJECTION016080-005Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Hospira
MANNITOL 10%
mannitol
INJECTABLE;INJECTION016269-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Miles
MANNITOL 20%
mannitol
INJECTABLE;INJECTION016472-004Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
Merck
MANNITOL 25%
mannitol
INJECTABLE;INJECTION005620-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mannitol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmaxis Ltd
ARIDOL KIT
mannitol
POWDER;INHALATION022368-001Oct 5, 20105,817,028► Subscribe
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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 verifification 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.

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