MANNITOL 5% Drug Patent Profile
✉ Email this page to a colleague
When do Mannitol 5% patents expire, and what generic alternatives are available?
Mannitol 5% is a drug marketed by B Braun, Hospira, and Icu Medical Inc. and is included in four NDAs.
The generic ingredient in MANNITOL 5% 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MANNITOL 5%?
- What are the global sales for MANNITOL 5%?
- What is Average Wholesale Price for MANNITOL 5%?
Summary for MANNITOL 5%
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 178 |
| Clinical Trials: | 225 |
| DailyMed Link: | MANNITOL 5% at DailyMed |
Recent Clinical Trials for MANNITOL 5%
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 |
Pharmacology for MANNITOL 5%
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
US Patents and Regulatory Information for MANNITOL 5%
| 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 5% | mannitol | INJECTABLE;INJECTION | 016080-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Icu Medical Inc | MANNITOL 5% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 019603-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | MANNITOL 5% | mannitol | INJECTABLE;INJECTION | 016269-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| B Braun | MANNITOL 5% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 020006-001 | Jul 26, 1993 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| B Braun | MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12% | mannitol | INJECTABLE;INJECTION | 016080-007 | 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 5%
| 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 |
