BRONCHITOL Drug Patent Profile
✉ Email this page to a colleague
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. Nine 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: | 176 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,221 |
| 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 |
|---|---|
| Chiesi USA, Inc. | Phase 4 |
| University of North Carolina, Chapel Hill | Phase 4 |
| University of Pittsburgh | Phase 1 |
Pharmacology for BRONCHITOL
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for BRONCHITOL
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chiesi | BRONCHITOL | mannitol | POWDER;INHALATION | 202049-001 | Oct 30, 2020 | RX | Yes | Yes | ⤷ 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 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 |
