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Last Updated: November 8, 2024

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BRONCHITOL Drug Patent Profile


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Which patents cover Bronchitol, and when can generic versions of Bronchitol launch?

Bronchitol is a drug marketed by Pharmaxis Europe and is included in one NDA.

The generic ingredient in BRONCHITOL 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 BRONCHITOL
Drug patent expirations by year for BRONCHITOL
Drug Prices for BRONCHITOL

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Recent Clinical Trials for BRONCHITOL

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SponsorPhase
Chiesi USA, Inc.Phase 4
University of North Carolina, Chapel HillPhase 4
Tim CorcoranPhase 1

See all BRONCHITOL clinical trials

Pharmacology for BRONCHITOL
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for BRONCHITOL

BRONCHITOL is protected by zero US patents and one FDA Regulatory Exclusivity.

FDA Regulatory Exclusivity protecting BRONCHITOL

ADD-ON MAINTENANCE THERAPY TO IMPROVE PULMONARY FUNCTION IN ADULT PATIENTS 18 YEARS OF AGE AND OLDER WITH CYSTIC FIBROSIS AND WHO HAVE PASSED THE BRONCHITOL TOLERANCE TEST
Exclusivity Expiration: ⤷  Sign Up

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmaxis Europe BRONCHITOL mannitol POWDER;INHALATION 202049-001 Oct 30, 2020 RX Yes Yes ⤷  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 BRONCHITOL

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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