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Last Updated: May 24, 2022

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 Chiesi 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.

US Patents and Regulatory Information for BRONCHITOL

BRONCHITOL is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting BRONCHITOL

NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chiesi BRONCHITOL mannitol POWDER;INHALATION 202049-001 Oct 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Chiesi BRONCHITOL mannitol POWDER;INHALATION 202049-001 Oct 30, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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