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Last Updated: March 29, 2024

MANNITOL 15% Drug Patent Profile


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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.

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-003 Jul 26, 1993 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MANNITOL 15% mannitol INJECTABLE;INJECTION 016269-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Miles MANNITOL 15% mannitol INJECTABLE;INJECTION 016472-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Icu Medical Inc MANNITOL 15% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-003 Jan 8, 1990 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 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

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