MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER Drug Patent Profile
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Which patents cover Mannitol 10% W/ Dextrose 5% In Distilled Water, and when can generic versions of Mannitol 10% W/ Dextrose 5% In Distilled Water launch?
Mannitol 10% W/ Dextrose 5% In Distilled Water is a drug marketed by B Braun and is included in one NDA.
The generic ingredient in MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER 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% W/ DEXTROSE 5% IN DISTILLED WATER
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 1 |
Formulation / Manufacturing: | see details |
DailyMed Link: | MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER at DailyMed |
Recent Clinical Trials for MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Washington University School of Medicine | Phase 4 |
See all MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER clinical trials
Anatomical Therapeutic Chemical (ATC) Classes for MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
US Patents and Regulatory Information for MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
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% 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% W/ DEXTROSE 5% IN DISTILLED WATER
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 |