MANNITOL 10% Drug Patent Profile
Which patents cover Mannitol 10%, and when can generic versions of Mannitol 10% launch?
Mannitol 10% is a drug marketed by B Braun, Hospira, Miles, and Otsuka Icu Medcl. and is included in five NDAs.
The generic ingredient in MANNITOL 10% 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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Summary for MANNITOL 10%
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 5 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 244 |
| DailyMed Link: | MANNITOL 10% at DailyMed |
Recent Clinical Trials for MANNITOL 10%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Xiangya Hospital of Central South University | PHASE4 |
| Stanford University | PHASE1 |
| Emmanuel Carrera | PHASE2 |
Pharmacology for MANNITOL 10%
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
US Patents and Regulatory Information for MANNITOL 10%
| 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 10% | mannitol | INJECTABLE;INJECTION | 016080-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| B Braun | MANNITOL 10% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 020006-002 | Jul 26, 1993 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | MANNITOL 10% | mannitol | INJECTABLE;INJECTION | 016269-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Miles | MANNITOL 10% | mannitol | INJECTABLE;INJECTION | 016472-002 | 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 10%
| 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 |
