Mannitol - Generic Drug Details

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What are the generic drug sources for mannitol and what is the scope of freedom to operate?

Mannitol is the generic ingredient in twenty-six branded drugs marketed by B Braun, Hospira, Miles, Icu Medical Inc, Abraxis Pharm, Fresenius Kabi Usa, Igi Labs Inc, Intl Medication, Luitpold, Merck, Watson Labs, Baxter Hlthcare, and Pharmaxis Europe, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eighteen drug master file entries for mannitol. Ten suppliers are listed for this compound.

Summary for mannitol

US Patents:	0
Tradenames:	26
Applicants:	13
NDAs:	22
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	176
Clinical Trials:	225
Patent Applications:	7,113
Drug Prices:	Drug price trends for mannitol
What excipients (inactive ingredients) are in mannitol?	mannitol excipients list
DailyMed Link:	mannitol at DailyMed

See drug prices for mannitol

Recent Clinical Trials for mannitol

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

Sponsor	Phase
University Hospital, Geneva	Phase 3
Morten Hostrup, PhD	N/A
Ecole Polytechnique Fédérale de Lausanne	Early Phase 1

See all mannitol clinical trials

Pharmacology for mannitol

Drug Class	Osmotic Diuretic
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Diuresis

Medical Subject Heading (MeSH) Categories for mannitol

Diuretics, Osmotic
Sweetening Agents

US Patents and Regulatory Information for mannitol

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Glossary

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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 15% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684-008	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Icu Medical Inc	SORBITOL-MANNITOL IN PLASTIC CONTAINER	mannitol; sorbitol	SOLUTION;IRRIGATION	018316-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	089240-001	May 6, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Baxter Hlthcare	OSMITROL 5% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684-005	Approved Prior to Jan 1, 1982	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for mannitol

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmaxis Europe	ARIDOL KIT	mannitol	POWDER;INHALATION	022368-001	Oct 5, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for mannitol

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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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