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Last Updated: March 19, 2024

MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% Drug Patent Profile


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Which patents cover Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12%, and what generic alternatives are available?

Mannitol 5% W/ Dextrose 5% In Sodium Chloride 0.12% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% 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 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Drug patent expirations by year for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
Recent Clinical Trials for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

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 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% clinical trials

US Patents and Regulatory Information for MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

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 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 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%

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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