Mannitol - Generic Drug Details
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What are the generic drug sources for mannitol and what is the scope of patent protection?
Mannitol
is the generic ingredient in twenty-six branded drugs marketed by B Braun, Hospira, Miles, Icu Medical Inc, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, Watson Labs, Baxter Hlthcare, Arna Pharma, and Chiesi, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.There are eighteen drug master file entries for mannitol. Nine suppliers are listed for this compound.
Summary for mannitol
| US Patents: | 0 |
| Tradenames: | 26 |
| Applicants: | 14 |
| NDAs: | 22 |
| Drug Master File Entries: | 18 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 176 |
| Clinical Trials: | 222 |
| Patent Applications: | 7,113 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for mannitol |
| What excipients (inactive ingredients) are in mannitol? | mannitol excipients list |
| DailyMed Link: | mannitol at DailyMed |
Recent Clinical Trials for mannitol
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Ecole Polytechnique Fédérale de Lausanne | Early Phase 1 |
| Centre Hospitalier Universitaire Vaudois | Early Phase 1 |
| University Hospital Inselspital, Berne | Early Phase 1 |
Pharmacology for mannitol
| Drug Class | Osmotic Diuretic |
| Mechanism of Action | Osmotic Activity |
| Physiological Effect | Increased Diuresis |
Medical Subject Heading (MeSH) Categories for mannitol
US Patents and Regulatory Information for mannitol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun | RESECTISOL IN PLASTIC CONTAINER | mannitol | SOLUTION;IRRIGATION | 016772-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Abraxis Pharm | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 086754-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| B Braun | MANNITOL 20% | mannitol | INJECTABLE;INJECTION | 014738-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Luitpold | MANNITOL 25% | mannitol | INJECTABLE;INJECTION | 087409-001 | Jan 21, 1982 | DISCN | 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 |
Expired US Patents for mannitol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Arna Pharma | ARIDOL KIT | mannitol | POWDER;INHALATION | 022368-001 | Oct 5, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for mannitol
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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