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Last Updated: March 28, 2024

MANNITOL 20% Drug Patent Profile


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Which patents cover Mannitol 20%, and when can generic versions of Mannitol 20% launch?

Mannitol 20% is a drug marketed by B Braun, Hospira, Miles, and Icu Medical Inc. and is included in six NDAs.

The generic ingredient in MANNITOL 20% 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 20%

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 20% mannitol INJECTABLE;INJECTION 014738-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Miles MANNITOL 20% mannitol INJECTABLE;INJECTION 016472-004 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 016080-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MANNITOL 20% mannitol INJECTABLE;INJECTION 016269-004 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Icu Medical Inc MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 019603-004 Jan 8, 1990 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
B Braun MANNITOL 20% IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 020006-004 Jul 26, 1993 AP RX 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 20%

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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