Ascorbic acid - Generic Drug Details

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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 eighteen branded drugs marketed by Mcguff, Fresenius Kabi Usa, Pharmobedient, Zydus Pharms, Sandoz Canada Inc, Apotex, Hospira, Roche, Abraxis Pharm, Watson Labs, Teligent, Salix Pharms, Novel Labs Inc, Taro, and Norgine, and is included in twenty NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for ascorbic acid

US Patents:	11
Tradenames:	18
Applicants:	13
NDAs:	18
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	230
Patent Applications:	9,443
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
Center for Cell and Gene Therapy, Baylor College of Medicine	EARLY_PHASE1
Baylor College of Medicine	EARLY_PHASE1
The Methodist Hospital Research Institute	EARLY_PHASE1

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
Norgine	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		DISCN	Yes	No			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
Sandoz Canada Inc	INFUVITE PEDIATRIC	ascorbic acid; biotin; cholecalciferol; cyanocobalamin; dexpanthenol; folic acid; niacinamide; pyridoxine; riboflavin; thiamine; tocopherol acetate; vitamin a; vitamin k	INJECTABLE;INTRAVENOUS	021265-001	Feb 21, 2001	AP	RX	Yes	Yes
Hospira	M.V.I. ADULT	ascorbic acid; biotin; cyanocobalamin; dexpanthenol; ergocalciferol; folic acid; niacinamide; pyridoxine hydrochloride; riboflavin 5'-phosphate sodium; thiamine hydrochloride; vitamin a; vitamin e; vitamin k	INJECTABLE;INTRAVENOUS	021625-001	Jan 30, 2004		DISCN	Yes	No
Norgine	PLENVU	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	209381-001	May 4, 2018		DISCN	Yes	No			Y
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881-001	Aug 2, 2006	AA	RX	Yes	Yes