MANNITOL 25% Drug Patent Profile
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When do Mannitol 25% patents expire, and when can generic versions of Mannitol 25% launch?
Mannitol 25% is a drug marketed by Abraxis Pharm, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Luitpold, Merck, and Watson Labs. and is included in nine NDAs.
The generic ingredient in MANNITOL 25% 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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Questions you can ask:
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Summary for MANNITOL 25%
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 176 |
| Clinical Trials: | 225 |
| Patent Applications: | 4,201 |
| DailyMed Link: | MANNITOL 25% at DailyMed |
Recent Clinical Trials for MANNITOL 25%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Geneva | Phase 3 |
| Morten Hostrup, PhD | N/A |
| Ecole Polytechnique Fédérale de Lausanne | Early Phase 1 |
Pharmacology for MANNITOL 25%
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
US Patents and Regulatory Information for MANNITOL 25%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abraxis Pharm | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 086754-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Intl Medication | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 083051-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269-006 | Aug 25, 1994 | AP | RX | No | No | ⤷ 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 MANNITOL 25%
| 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 |
