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Last Updated: March 29, 2024

MANNITOL 25% Drug Patent Profile


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US Patents and Regulatory Information for MANNITOL 25%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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
Intl Medication MANNITOL 25% mannitol INJECTABLE;INJECTION 083051-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hospira MANNITOL 25% mannitol INJECTABLE;INJECTION 016269-006 Aug 25, 1994 AP RX 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
Fresenius Kabi Usa MANNITOL 25% mannitol INJECTABLE;INJECTION 080677-001 Approved Prior to Jan 1, 1982 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 25%

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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