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 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.

Sponsor	Phase
The Canadian College of Naturopathic Medicine	Phase 2
Ottawa Hospital Research Institiute	Phase 2
University Hospital, Lille	Phase 2

Sponsor

Phase

The Canadian College of Naturopathic Medicine

Phase 2

Ottawa Hospital Research Institiute

Phase 2

University Hospital, Lille

Phase 2

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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
Hospira	M.V.I. ADULT (PHARMACY BULK PACKAGE)	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	021643-001	Feb 18, 2004		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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