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Last Updated: March 19, 2024

OSMITROL 5% IN WATER IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Osmitrol 5% In Water In Plastic Container, and when can generic versions of Osmitrol 5% In Water In Plastic Container launch?

Osmitrol 5% In Water In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in OSMITROL 5% IN WATER IN PLASTIC CONTAINER 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.

Drug patent expirations by year for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Recent Clinical Trials for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Clinical Network ServicesPhase 1
Linear Clinical ResearchPhase 1
CPR Pharma Services Pty Ltd, AustraliaPhase 1

See all OSMITROL 5% IN WATER IN PLASTIC CONTAINER clinical trials

Pharmacology for OSMITROL 5% IN WATER IN PLASTIC CONTAINER
Drug ClassOsmotic Diuretic
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Diuresis

US Patents and Regulatory Information for OSMITROL 5% IN WATER IN PLASTIC CONTAINER

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 5% IN WATER IN PLASTIC CONTAINER mannitol INJECTABLE;INJECTION 013684-005 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 5% IN WATER IN PLASTIC CONTAINER

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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