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.
Summary for BRONCHITOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 156 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,114 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for BRONCHITOL |
| What excipients (inactive ingredients) are in BRONCHITOL? | BRONCHITOL excipients list |
| DailyMed Link: | BRONCHITOL at DailyMed |
Recent Clinical Trials for BRONCHITOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Pittsburgh | Phase 1 |
| Tim Corcoran | Phase 1 |
| Pharmaxis | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for BRONCHITOL
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 |
