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Last Updated: March 18, 2024

OSMITROL 10% IN WATER Drug Patent Profile


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When do Osmitrol 10% In Water patents expire, and when can generic versions of Osmitrol 10% In Water launch?

Osmitrol 10% In Water is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 10% IN WATER 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 OSMITROL 10% IN WATER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Baxter Hlthcare OSMITROL 10% IN WATER mannitol INJECTABLE;INJECTION 013684-002 Approved Prior to Jan 1, 1982 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Baxter Hlthcare OSMITROL 10% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-006 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 OSMITROL 10% IN WATER

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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