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Last Updated: March 19, 2024

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MANNITOL Drug Patent Profile


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

Mannitol is a drug marketed by B Braun, Hospira, Miles, Icu Medical Inc, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, and Watson Labs. and is included in fourteen NDAs.

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

Summary for MANNITOL
US Patents:0
Applicants:11
NDAs:14
Formulation / Manufacturing:see details
Drug Prices: Drug price information for MANNITOL
What excipients (inactive ingredients) are in MANNITOL?MANNITOL excipients list
DailyMed Link:MANNITOL at DailyMed
Drug patent expirations by year for MANNITOL
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

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 ⤷  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
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 ⤷  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.