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, Otsuka Icu Medcl, 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.
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Summary for MANNITOL
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 14 |
| 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 |
|---|---|
| Xiangya Hospital of Central South University | PHASE4 |
| Stanford University | PHASE1 |
| Emmanuel Carrera | PHASE2 |
Medical Subject Heading (MeSH) Categories for MANNITOL
Anatomical Therapeutic Chemical (ATC) Classes 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka Icu Medcl | MANNITOL 5% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 019603-001 | Jan 8, 1987 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Watson Labs | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 087460-001 | Jun 27, 1983 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| B Braun | MANNITOL 5% | mannitol | INJECTABLE;INJECTION | 016080-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ 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 MANNITOL
| 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 |
