MANNITOL 10% Drug Patent Profile
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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 Icu Medical Inc. and is included in five NDAs.
The generic ingredient in MANNITOL 10% 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 10%
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 87 |
Clinical Trials: | 222 |
Formulation / Manufacturing: | see details |
DailyMed Link: | MANNITOL 10% at DailyMed |
Recent Clinical Trials for MANNITOL 10%
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University Hospital Inselspital, Berne | Early Phase 1 |
Ecole Polytechnique Fédérale de Lausanne | Early Phase 1 |
Centre Hospitalier Universitaire Vaudois | Early Phase 1 |
Pharmacology for MANNITOL 10%
Drug Class | Osmotic Diuretic |
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for MANNITOL 10%
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
B Braun | MANNITOL 10% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 020006-002 | Jul 26, 1993 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hospira | MANNITOL 10% | mannitol | INJECTABLE;INJECTION | 016269-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Miles | MANNITOL 10% | mannitol | INJECTABLE;INJECTION | 016472-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
B Braun | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER | mannitol | INJECTABLE;INJECTION | 016080-006 | 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 10%
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 |