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 is one drug master file entry 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 MANNITOL 25%
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 9 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 244 |
| DailyMed Link: | MANNITOL 25% at DailyMed |
Recent Clinical Trials for MANNITOL 25%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Xiangya Hospital of Central South University | PHASE4 |
| Stanford University | PHASE1 |
| Emmanuel Carrera | PHASE2 |
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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Intl Medication | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 083051-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269-006 | Aug 25, 1994 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Luitpold | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 087409-001 | Jan 21, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Fresenius Kabi Usa | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 080677-001 | Approved Prior to Jan 1, 1982 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hospira | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 016269-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Igi Labs Inc | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 089240-001 | May 6, 1987 | DISCN | 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 MANNITOL 25%
| 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 |
