MANNITOL Drug Patent Profile
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Which patents cover Mannitol, and what generic alternatives are available?
Mannitol is a drug marketed by B Braun, Hospira, Miles, Icu Medical Inc, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, and Watson Labs. and is included in fourteen NDAs.
The generic ingredient in MANNITOL 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 MANNITOL
US Patents: | 0 |
Applicants: | 11 |
NDAs: | 14 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for MANNITOL |
What excipients (inactive ingredients) are in MANNITOL? | MANNITOL excipients list |
DailyMed Link: | MANNITOL at DailyMed |
Recent Clinical Trials for MANNITOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Ecole Polytechnique Fédérale de Lausanne | Early Phase 1 |
Centre Hospitalier Universitaire Vaudois | Early Phase 1 |
University Hospital Inselspital, Berne | Early Phase 1 |
Medical Subject Heading (MeSH) Categories for MANNITOL
US Patents and Regulatory Information for MANNITOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Icu Medical Inc | MANNITOL 5% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 019603-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 087460-001 | Jun 27, 1983 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
B Braun | MANNITOL 5% | mannitol | INJECTABLE;INJECTION | 016080-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 MANNITOL
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 |