Acetic acid, glacial - Generic Drug Details

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What are the generic drug sources for acetic acid, glacial and what is the scope of freedom to operate?

Acetic acid, glacial is the generic ingredient in fifteen branded drugs marketed by Actavis Mid Atlantic, Chartwell Rx, Kv Pharm, Rising, Sciegen Pharms, Sun Pharma Canada, Warner Chilcott, Hikma, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, Bausch And Lomb, Pharmafair, Bayer Pharms, Cosette Pharms Nc, Taro, Wockhardt, and Saptalis Pharms, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for acetic acid, glacial

US Patents:	0
Tradenames:	15
Applicants:	18
NDAs:	24
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	375
Clinical Trials:	1
DailyMed Link:	acetic acid, glacial at DailyMed

Recent Clinical Trials for acetic acid, glacial

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

Sponsor	Phase
National Institute of Perinatology	Phase 4
National Council of Science and Technology, Mexico	Phase 4

See all acetic acid, glacial clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for acetic acid, glacial

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for acetic acid, glacial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sciegen Pharms	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040607-001	Feb 24, 2005	AT	RX	No	Yes
Bayer Pharms	TRIDESILON	acetic acid, glacial; desonide	SOLUTION/DROPS;OTIC	017914-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bausch And Lomb	ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE	acetic acid, glacial; aluminum acetate	SOLUTION/DROPS;OTIC	040063-001	Feb 25, 1994		DISCN	No	No
Bayer Pharms	DOMEBORO	acetic acid, glacial; aluminum acetate	SOLUTION/DROPS;OTIC	084476-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Bayer Pharms	NEO-CORT-DOME	acetic acid, glacial; hydrocortisone; neomycin sulfate	SUSPENSION/DROPS;OTIC	050238-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Taro	HYDROCORTISONE AND ACETIC ACID	acetic acid, glacial; hydrocortisone	SOLUTION/DROPS;OTIC	088759-001	Mar 4, 1985	AT	RX	Yes	Yes
Chartwell Rx	ACETIC ACID	acetic acid, glacial	SOLUTION/DROPS;OTIC	040166-001	Jul 26, 1996		DISCN	No	No