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Ascorbic acid - Generic Drug Details

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

Ascorbic acid is the generic ingredient in fifteen branded drugs marketed by Mcguff, Sandoz Canada Inc, Hospira, Roche, Abraxis Pharm, Watson Labs, Teligent, Salix Pharms, Novel Labs Inc, Taro, and Salix, and is included in fifteen NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for ascorbic acid. One supplier is listed for this compound.

Summary for ascorbic acid

US Patents:	13
Tradenames:	15
Applicants:	11
NDAs:	15
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	171
Clinical Trials:	208
Patent Applications:	4,930
Drug Prices:	Drug price trends for ascorbic acid
What excipients (inactive ingredients) are in ascorbic acid?	ascorbic acid excipients list
DailyMed Link:	ascorbic acid at DailyMed

See drug prices for ascorbic acid

See drug sales revenues for ascorbic acid

Recent Clinical Trials for ascorbic acid

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

Sponsor	Phase
The Canadian College of Naturopathic Medicine	Phase 2
Ottawa Hospital Research Institiute	Phase 2
Centre Hospitalier de Bethune	Phase 2

See all ascorbic acid clinical trials

Pharmacology for ascorbic acid

Drug Class

Vitamin C

Medical Subject Heading (MeSH) Categories for ascorbic acid

Antioxidants

Vitamins

Anatomical Therapeutic Chemical (ATC) Classes for ascorbic acid

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

S01XA	Other ophthalmologicals
S01X	OTHER OPHTHALMOLOGICALS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ascorbic acid

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		RX	Yes	Yes			Y
Teligent	M.V.I.-12 LYOPHILIZED	ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine; riboflavin 5'-phosphate sodium; thiamine; vitamin a; vitamin e	INJECTABLE;INJECTION	018933-002	Aug 8, 1985		DISCN	No	No
Hospira	VITAPED	ascorbic acid; biotin; cyanocobalamin; ergocalciferol; folic acid; niacinamide; pantothenic acid; phytonadione; pyridoxine; riboflavin; thiamine; vitamin a palmitate; vitamin e	INJECTABLE;INJECTION	020176-001	Dec 29, 1993		DISCN	No	No
Hospira	M.V.I.-12 ADULT	ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e	INJECTABLE;INJECTION	008809-004	Aug 8, 1985		DISCN	No	No
Novel Labs Inc	PEG-3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ASCORBATE AND ASCORBIC ACID	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	090145-001	Jan 25, 2012	AA	RX	No	No
Mcguff	ASCOR	ascorbic acid	SOLUTION;INTRAVENOUS	209112-001	Oct 2, 2017		RX	Yes	Yes