OSMITROL 5% IN WATER Drug Patent Profile
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When do Osmitrol 5% In Water patents expire, and what generic alternatives are available?
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.
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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 |
| 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 |
|---|---|
| Celtaxsys, Inc. | Phase 1 |
| Clinical Network Services | Phase 1 |
| Linear Clinical Research | Phase 1 |
Pharmacology for OSMITROL 5% IN WATER
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start 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 | ⤷ 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 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/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 |
