MANNITOL 15% Drug Patent Profile
✉ Email this page to a colleague
When do Mannitol 15% patents expire, and when can generic versions of Mannitol 15% launch?
Mannitol 15% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in five NDAs.
The generic ingredient in MANNITOL 15% 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MANNITOL 15%?
- What are the global sales for MANNITOL 15%?
- What is Average Wholesale Price for MANNITOL 15%?
Summary for MANNITOL 15%
US Patents: | 0 |
Applicants: | 4 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 178 |
Clinical Trials: | 225 |
Formulation / Manufacturing: | see details |
DailyMed Link: | MANNITOL 15% at DailyMed |
![MANNITOL 15% drug patent expirations Drug patent expirations by year for MANNITOL 15%](/p/graph/s/t/MANNITOL_15%-patent-expirations.png)
Recent Clinical Trials for MANNITOL 15%
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 15%
Drug Class | Osmotic Diuretic |
Mechanism of Action | Osmotic Activity |
Physiological Effect | Increased Diuresis |
US Patents and Regulatory Information for MANNITOL 15%
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
B Braun | MANNITOL 15% | mannitol | INJECTABLE;INJECTION | 016080-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
B Braun | MANNITOL 15% IN PLASTIC CONTAINER | mannitol | INJECTABLE;INJECTION | 020006-003 | Jul 26, 1993 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hospira | MANNITOL 15% | mannitol | INJECTABLE;INJECTION | 016269-003 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Miles | MANNITOL 15% | mannitol | INJECTABLE;INJECTION | 016472-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
B Braun | MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45% | mannitol | INJECTABLE;INJECTION | 016080-005 | Approved Prior to Jan 1, 1982 | DISCN | 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 15%
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 |