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Mannitol - Generic Drug Details

What are the generic sources for mannitol and what is the scope of patent protection?

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

Anatomical Therapeutic Chemical (ATC) Classes for mannitol

A06AD	Osmotically acting laxatives
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

B05BC	Solutions producing osmotic diuresis
B05B	I.V. SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05CX	Other irrigating solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

R05CB	Mucolytics
R05C	EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

V04CX	Other diagnostic agents
V04C	OTHER DIAGNOSTIC AGENTS
V04	DIAGNOSTIC AGENTS
V	Various

US Patents and Regulatory Information for mannitol

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 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%	mannitol	INJECTABLE;INJECTION	016080-005	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	MANNITOL 20% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	020006-004	Jul 26, 1993	AP	RX	No	No
Icu Medical Inc	MANNITOL 20% IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	019603-004	Jan 8, 1990	AP	RX	No	No
Baxter Hlthcare	OSMITROL 10% IN WATER IN PLASTIC CONTAINER	mannitol	INJECTABLE;INJECTION	013684-006	Approved Prior to Jan 1, 1982	AP	RX	No	No
B Braun	MANNITOL 20%	mannitol	INJECTABLE;INJECTION	014738-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	OSMITROL 10% IN WATER	mannitol	INJECTABLE;INJECTION	013684-002	Approved Prior to Jan 1, 1982	AP	RX	No	No
Fresenius Kabi Usa	MANNITOL 25%	mannitol	INJECTABLE;INJECTION	080677-001	Approved Prior to Jan 1, 1982	AP	RX	No	No

Expired US Patents for mannitol

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

EU/EMA Drug Approvals for mannitol

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