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 is one drug master file entry for this compound. Nine suppliers are listed for this compound. Additional details are available on the mannitol profile page.
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Questions you can ask:
- What is the 5 year forecast for BRONCHITOL?
- What are the global sales for BRONCHITOL?
- What is Average Wholesale Price for BRONCHITOL?
Summary for BRONCHITOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 176 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,126 |
| 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 North Carolina, Chapel Hill | Phase 4 |
| Chiesi USA, Inc. | Phase 4 |
| University of Pittsburgh | Phase 1 |
US Patents and Regulatory Information for BRONCHITOL
BRONCHITOL is protected by zero US patents and one FDA Regulatory Exclusivity.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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/001252Bronchitol 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 |
