OSMITROL 5% IN WATER Drug Patent Profile
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Which patents cover Osmitrol 5% In Water, and when can generic versions of Osmitrol 5% In Water launch?
Osmitrol 5% In Water is a drug marketed by Baxter Hlthcare and is included in one NDA.
The generic ingredient in OSMITROL 5% IN 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 OSMITROL 5% IN WATER
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 178 |
Clinical Trials: | 6 |
Formulation / Manufacturing: | see details |
DailyMed Link: | OSMITROL 5% IN WATER at DailyMed |
Recent Clinical Trials for OSMITROL 5% IN WATER
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
CPR Pharma Services Pty Ltd, Australia | Phase 1 |
Celtaxsys, Inc. | Phase 1 |
Clinical Network Services | Phase 1 |
Pharmacology for OSMITROL 5% IN WATER
Drug Class | Osmotic Diuretic |
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Diuresis |
Anatomical Therapeutic Chemical (ATC) Classes for OSMITROL 5% IN WATER
US Patents and Regulatory Information for OSMITROL 5% IN WATER
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Baxter Hlthcare | OSMITROL 5% IN WATER | mannitol | INJECTABLE;INJECTION | 013684-001 | Approved Prior to Jan 1, 1982 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Baxter Hlthcare | OSMITROL 5% IN WATER IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 013684-005 | Approved Prior to Jan 1, 1982 | AP | RX | 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 OSMITROL 5% IN 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 |