RESECTISOL Drug Patent Profile
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When do Resectisol patents expire, and what generic alternatives are available?
Resectisol is a drug marketed by B Braun and is included in two NDAs.
The generic ingredient in RESECTISOL 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.
Summary for RESECTISOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 176 |
Clinical Trials: | 3 |
Patent Applications: | 4,186 |
Formulation / Manufacturing: | see details |
DailyMed Link: | RESECTISOL at DailyMed |
Recent Clinical Trials for RESECTISOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1/Phase 2 |
Oregon Health and Science University | Phase 1/Phase 2 |
National Cancer Institute (NCI) | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for RESECTISOL
US Patents and Regulatory Information for RESECTISOL
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 | mannitol | SOLUTION;IRRIGATION | 016704-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
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 | ||||
>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 RESECTISOL
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 |