MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% Drug Patent Profile
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When do Mannitol 15% W/ Dextrose 5% In Sodium Chloride 0.45% patents expire, and what generic alternatives are available?
Mannitol 15% W/ Dextrose 5% In Sodium Chloride 0.45% is a drug marketed by B Braun and is included in one NDA.
The generic ingredient in MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% 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 MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 225 |
| DailyMed Link: | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% at DailyMed |
Recent Clinical Trials for MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Geneva | Phase 3 |
| Morten Hostrup, PhD | N/A |
| University Hospital Inselspital, Berne | Early Phase 1 |
See all MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% clinical trials
US Patents and Regulatory Information for MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | mannitol | INJECTABLE;INJECTION | 016080-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
| 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 |
