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Last Updated: November 22, 2024

MANNITOL 20% Drug Patent Profile


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Which patents cover Mannitol 20%, and what generic alternatives are available?

Mannitol 20% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in six NDAs.

The generic ingredient in MANNITOL 20% is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.

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Summary for MANNITOL 20%
Drug patent expirations by year for MANNITOL 20%
Recent Clinical Trials for MANNITOL 20%

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SponsorPhase
University Hospital, GenevaPhase 3
Morten Hostrup, PhDN/A
Ecole Polytechnique Fédérale de LausanneEarly Phase 1

See all MANNITOL 20% clinical trials

Pharmacology for MANNITOL 20%
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for MANNITOL 20%

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% mannitol INJECTABLE;INJECTION 014738-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Miles MANNITOL 20% mannitol INJECTABLE;INJECTION 016472-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
B Braun MANNITOL 20% mannitol INJECTABLE;INJECTION 016080-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hospira MANNITOL 20% mannitol INJECTABLE;INJECTION 016269-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 20%

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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