OSMITROL 20% IN WATER IN PLASTIC CONTAINER Drug Patent Profile
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Which patents cover Osmitrol 20% In Water In Plastic Container, and what generic alternatives are available?
Osmitrol 20% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.
The generic ingredient in OSMITROL 20% IN WATER IN PLASTIC CONTAINER is mannitol. There are eighteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the mannitol profile page.
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Summary for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 92 |
| Clinical Trials: | 6 |
| DailyMed Link: | OSMITROL 20% IN WATER IN PLASTIC CONTAINER at DailyMed |
Recent Clinical Trials for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
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 |
See all OSMITROL 20% IN WATER IN PLASTIC CONTAINER clinical trials
Pharmacology for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
US Patents and Regulatory Information for OSMITROL 20% IN WATER IN PLASTIC CONTAINER
| 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 20% IN WATER IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 013684-007 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 20% IN WATER IN PLASTIC CONTAINER
| 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 |
